[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hpv-positive-oropharyngeal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hpv-positive-oropharyngeal-squamous-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,44,112,148,173,212,234,257,281,302,328,362,399,431,453,476,508,535,563,591,619,646],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100639699","phase-1-combining-neo-adjuvant-atr-inhibition-with-nodal-sbrt-for-early-stage-resectable-hpv-opsccs-100639699",false,"NCT07578467","Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","A Phase Ib\u002FII Study Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","Inclusion Criteria:\n\n* Age ≥ 18\n* Patients that have been diagnosed with HPV-positive throat cancer (OPSCC) at an early stage (stage I or II), confirmed by a biopsy.\n* Patients' blood calcium level is within a safe range\n* Patients' blood, kidney, and liver health are strong enough, shown through specific medical test results\n* If a participant is female, she must not be pregnant or breastfeeding.\n* If a participant is male, he must agree to use highly effective birth control from the start of the study until a short period after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients with late-stage tumors (Stage III or IV)\n* If the cancer has already spread to distant parts of the body (M1) when first diagnosed\n* Prior advanced head and neck cancer requiring radiation or major surgery\n* Patients whose original tumor site cannot be identified\n* Patients that have a known additional malignancy that is progressing or requires active treatment\n* Patients that had a surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119. This does not include procedures that are used to diagnose or determine extent of study disease (such as biopsies).\n* Patients taking medications that strongly affect how the body processes certain drugs (CYP enzymes) at the same time as the study treatment.\n* Patients with active infections and\u002For receiving systemic antibiotics or anti-viral medications.\n* Patients with uncontrolled HIV or active hepatitis B or C are usually not eligible. However, those whose infections are well-controlled on treatment for at least a month and meet certain viral load limits can participate\n* Current or past diagnosis of leukemia within the past 5 years.\n* Patients with a history of non-malignant gastrointestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.\n* Patient has uncontrolled hypertension at time of enrollment.\n* Patients who recently had serious kidney problems or kidney disease.\n* Patients cannot have taken another experimental drug within 30 days-or within a period equal to five times that drug's half-life-before starting this study\n* Medical illness that, in the opinion of the Investigator, may impact the safety of the patient\n* Patients who use recreational drugs or have mental health conditions that might make it hard to follow study visits, based on the doctor's judgment.\n* Known hypersensitivity to ATRN-119 or its ingredients\n* Patients with serious liver disease or liver problems that could affect how the body processes the study drug\n* Patients who are fairly limited in daily activities (ECOG score of 2 or higher)\n* Patients with serious other health problems that the doctor thinks could prevent them from completing the study\n* Pregnancy or lactation\n* Inability to provide informed consent","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This research study is testing whether a new study drug (called ATRN-119) is safe and effective when combined with a single, highly targeted dose of radiation therapy (called stereotactic body radiation therapy or SBRT) to treat early-stage throat cancer that is caused by HPV.\n\nThe goal of this study is to treat cancer effectively while reducing side effects and helping patients maintain a better quality of life over the long term. Researchers hope that this approach will be just as successful-or possibly more successful-than current treatments, which already have high cure rates.\n\nParticipants will:\n\n* Take 800mg of ATRN-119 every day for 10 days\n* Receive 1 treatment (called a \"fraction\") of SBRT to the neck on day 3 of ATRN-119 dosing.\n* Keep a short diary to track ATRN-119 dosing. The diary will be provided by study team\n* Receive standard of care treatment after treatment with ATRN-119 + SBRT including TransOral Robotic Surgery (TORS) to remove the primary tumor with Neck Dissection and adjuvant therapy (if indicated)\n* Receive additional safety checkups and tests by researchers during routine visits with their cancer doctor for 2 years after study treatment",[27,28,29,30,31],"HPV Positive Oropharyngeal Squamous Cell Carcinoma","Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","HPV Associated Cancers","Oropharyngeal HPV Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":20},"2026-05-31",{"date":40,"type":20},"2030-05-31",{"name":42,"class":43},"Abramson Cancer Center at Penn Medicine","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":76,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983","NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.",{"count":52,"type":20},20,[24],"This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[56,57,58,59,60,61,62,63,64,65,66,67,68,27,69,70,71,72,73,74,75],"Cervical Cancer","Throat Cancer","Oropharynx Cancer","Anal Cancer","Vulva Cancer","Vaginal Cancer","Penile Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","RECRUITING","2026-06-10",{"date":104,"type":36},"2026-06-12",{"date":106,"type":36},"2023-03-07",{"date":108,"type":20},"2027-01-01",{"name":110,"class":43},"Christian Hinrichs",3,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100488427","phase-1-e7-t-cell-receptor-tcr--t-cell-induction-therapy-for-locoregionally-advanced-hpv-associated-cancers-100488427","NCT05639972","E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers","A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.\n2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative.\n10. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate aminotransferase (AST) (SGOT)\u002F alanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n11. Participants must be able to understand and be willing to sign the written informed consent document.\n12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.\n\nNote: Patients may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.\n2. Current treatment with another investigational agent.\n3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n5. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.\n6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated.\n8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":120,"type":20},15,[23,24],"The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.\n\nThis study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years.\n\nParticipants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.",[124,65,64,27,68,70,67,72,73,74,71,56,58,59,125,62,61],"HPV-Associated Cervical Carcinoma","Vulvar Cancer",[86,127,128,129,130,131,132,78,89,81,133,134,135,136,137,138,139,140],"Cell therapy","Adoptive cell therapy","Immunotherapy","Radiation","Chemoradiation","CAR-T, cell therapy","Gene therapy","Cervical cancer","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy",{"date":104,"type":36},{"date":143,"type":36},"2025-08-11",{"date":145,"type":20},"2026-10-01",{"name":110,"class":43},2,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":147},"100632410","phase-2-risk-adapted-therapy-in-hpv-positive-oropharyngeal-cancer-using-circulating-tumor-ct-hpv-dna-profiling-react-20-100632410","NCT07513324","Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed, stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. Participants with HPV-associated disease of unknown primary (cT0) are eligible.\n\n  * Participants who undergo upfront surgery are permitted to enroll if their post-operative pathology necessitates that they receive adjuvant therapy.\n  * Participants who undergo upfront induction chemotherapy with platinum-based therapy are eligible if they have less than a complete clinical or radiologic response to induction as judged by the treating investigator(s).\n  * Participants with locoregionally recurrent disease are eligible if they completed definitive or curative-intent treatment and meet criteria 3.1, 6e below.\n* HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following: (a) IHC staining for p16 with ≥70% expression, and\u002For (b) DNA testing (PCR or ISH) for high-risk subtypes 16, 18, 31, 33, or 35.\n* Tumor tissue available for PD-L1 CPS testing.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Intermediate or high-risk HPV+ disease defined by any one of the following:\n\n  * TTMV-HPV DNA score \\>200 at baseline and failure to clear by \\>95% by week 4-5 of treatment\n  * undetectable or low (≤200) TTMV-HPV DNA at baseline prior to treatment with clinical or pathologic T3-4 or N2-3 disease\n  * known HPV subtypes 18, 31, 33, or 35 (but excluding cT1-2N0 participants)\n  * known N3 disease or fixed neck nodes as judged by the treating investigator(s)\n  * any stage disease with known detectable TTMV-HPV DNA 6 weeks or onward from completion of definitive or curative-intent therapy without clinical or radiographic disease and with no additional intervening therapy administered.\n* Participants should have adequate organ and marrow function to receive adjuvant immunotherapy as outlined below:\n\n  * Absolute neutrophil count (ANC) ≥1500\u002FµL\n  * Platelets \\> 100,000\u002FµL\n  * Hemoglobin ≥9.0g.\u002FdL or ≥5.6 mmol\u002FLa\n  * Creatinine OR Measured or calculated b creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n  * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n  * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n  * International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Participants or persons of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 72 hours prior to the start of therapy. Note: Contraception requirements should conform with CTFG guidelines. The pembrolizumab standard for use of highly effective contraceptive methods for POCBP is 120 days (5 half-lives) after the last dose. Abstaining from breastfeeding after study intervention is at least 5 half-lives or 120 days.\n\nExclusion Criteria:\n\n* Participants with AJCC 2017 8th edition stage IV (M1, metastatic) disease.\n* Pregnant or lactating women.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or another stimulatory or co-inhibitory T-cell receptor treatment.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of pembrolizumab.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days of first pembrolizumab dosing.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Participants with a history of allogeneic tissue\u002Fsolid organ transplant are excluded.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of uncontrolled human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority. Well-controlled typically includes a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening and achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n* Has a known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease is permitted if chance of recurrence is thought to be low (in discussion with the Sponsor-investigator).\n* ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\na Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n\nb Creatinine clearance (CrCl) should be calculated per institutional standard.",{"count":155,"type":20},116,[24],"The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.",[159,160],"HPV-positive Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma",[162,163],"HPV-positive oropharyngeal squamous cell carcinoma","Oropharyngeal squamous cell carcinoma","2026-06-08",{"date":166,"type":36},"2026-06-09",{"date":168,"type":20},"2026-07-01",{"date":170,"type":20},"2030-01-01",{"name":172,"class":43},"Dana-Farber Cancer Institute",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100639509","phase-2-phase-2-study-of-nai-hpv-vaccine-and-nab-paclitaxel-in-hpv-positive-oropharyngeal-cancer-followed-by-de-intensified-radiation-compared-with-standard-chemoradiation-100639509","NCT07628062","Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation","Open-Label, Single-Arm Phase 2 Study Of Nogapendekin Alfa Inbakicept, PD-L1 T-HaNK, And Bevacizumab And Randomized Phase 2B Study Of Nogapendekin Alfa Inbakicept, Bevacizumab, And Tumor Treatment Fields With Or Without PD-L1 T-HaNK In Participants With Recurrent Or Progressive Glioblastoma","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed squamous cell carcinoma of the oropharynx that is HPV-positive (p16 immunohistochemistry positive and\u002For HPV DNA positive). Patients with cervical lymph node metastases from an unknown primary can be included if p16-positive and likely OPSCC origin.\n5. Locally advanced, stage III\u002FIV HPV-associated OPSCC that is a candidate for definitive chemoradiation. Specifically, tumors classified as T3 or T4 and\u002For node-positive disease (N2 or N3), without distant metastases (M0). Patients with very low-risk disease (e.g. T1-T2 N0-1) are excluded, as these might be handled with less intensive standard therapy or surgery rather than this trial approach.\n6. No prior definitive treatment for the current OPSCC. Patients must be treatment-naïve with respect to chemotherapy, radiation, or investigational therapy for this cancer. Prior diagnostic biopsy is allowed, but no prior curative surgery or radiation to the head and neck.\n7. Participants should be suitable for organ-preserving therapy (i.e., radiation) with no immediate need for surgical resection (the trial is non-surgical upfront).\n8. Must be willing to accept the randomized treatment assignment after the safety lead-in. During the initial safety phase, all participants receive experimental therapy; once randomization begins, patients and investigators will not choose the arm - it will be assigned by the randomization schedule. Enrolled patients should have no clear contraindication to either arm's therapy (for instance, a patient who absolutely cannot receive cisplatin due to allergy or comorbidity might not be suitable, since cisplatin is required in both arms). The inclusion\u002Fexclusion criteria are structured to ensure a homogeneous population suitable for both the experimental approach and SOC chemoradiation.\n9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n10. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Per cisplatin prescribing information, female participants of child-bearing potential must agree to use effective contraception for up to 14 months and non-sterile male participants must agree to use a condom for up to 11 months after last dose of cisplatin. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.\n\nExclusion Criteria:\n\n1. HPV-negative or Non-OPSCC: Tumors that are p16-negative or not in the oropharynx are excluded.\n2. Any evidence of distant metastases (M1 disease) excludes the patient, since the trial is for curative-intent local\u002Fregional therapy.\n3. Previous radiation in the head\u002Fneck region or prior chemotherapy\u002Fimmunotherapy for this cancer disqualifies the patient. We require a clean baseline to assess our regimen.\n4. Active autoimmune disease or immunosuppression. The experimental arm includes immunotherapy (IL-15 receptor agonist and IBRX-042 vaccine), patients with active serious autoimmune disorders or those requiring immunosuppressive medications (e.g. chronic steroids \\>10 mg prednisone daily) are excluded to avoid severe immune-related complications. Well-controlled or mild autoimmune conditions may be considered on a case-by-case basis if risk is low.\n5. Inadequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to baseline:\n\n   1. Absolute neutrophil count (ANC) \\\u003C 1,500 cells\u002FμL without granulocyte colony-stimulating factor support\n   2. Platelet count \\\u003C 100,000\u002FμL without transfusion\n   3. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\> 2.5 × ULN, with the following exception:\n\n      Participants with documented liver metastases: AST and\u002For ALT \\> 5 × ULN\n   4. Serum bilirubin ≤ 3 × ULN\n   5. Creatinine clearance ≤ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n   6. Serum albumin \\\u003C 3.0 g\u002FdL.\n6. Significant cardiovascular disease (such as New York Heart Association cardiac disease class II or greater), myocardial infarction within 3 months prior to baseline, unstable arrhythmias, or unstable angina.\n7. Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n8. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and\u002For a detectable HIV viral load.\n9. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.\n10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n11. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study.\n12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n13. Pregnant and nursing women.",{"count":181,"type":20},70,[24],"This Phase 2a\u002F2 study evaluates the safety, tolerability, and efficacy of neoadjuvant and adjuvant NAI, hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). The study includes a Phase 2a safety lead-in followed by a randomized Phase 2 comparison of a de-intensified experimental chemoradiation approach versus standard-of-care chemoradiation.",[185,160,186],"HPV-Positive Oropharyngeal Squamous Cell Carcinoma","Head and Neck Cancer",[188,189,190,191,131,192,193,194,195,196,197,198,199,200,201],"Locally Advanced HPV-Positive OPSCC","Human Papillomavirus-Associated Oropharyngeal Cancer","HPV-16","Squamous Cell Carcinoma of the Oropharynx","Cisplatin","Intensity-Modulated Radiation Therapy","De-Intensification Strategy","Neoadjuvant Therapy","Adjuvant Immunotherapy","hAd5 HPV Vaccine","ANKTIVA","Phase 2","NavDx","Head and Neck Squamous Cell Carcinoma","2026-06-01",{"date":204,"type":36},"2026-06-04",{"date":206,"type":20},"2026-07-22",{"date":208,"type":20},"2031-06-27",{"name":210,"class":211},"ImmunityBio, Inc.","INDUSTRY",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100631202","phase-2-reduced-elective-nodal-and-ctv-dose-for-hpv-oropharyngeal-squamous-cell-carcinoma-100631202","NCT07497607","Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma","Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)","REDUCE-30","Inclusion Criteria:\n\n1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.\n2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.\n3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.\n4. Patients must have measurable disease based on PET\u002FCT imaging completed within 45 days +\u002F- 1 week from date of eligibility confirmation.\n5. Age ≥18 years.\n6. ECOG performance status ≤2.\n7. Patients must be deemed eligible for planned SOC cisplatin per treating investigators and\u002For treating medical oncologist.\n8. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastatic or recurrent disease.\n\n  2\\. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive).\n\n  3\\. Prior radiotherapy resulting in overlap of radiation therapy fields.\n\n  4\\. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study.\n\n  5\\. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator.\n\n  6\\. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the Investigator.\n\n  7\\. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or not preferable, in the opinion of the Investigator.",{"count":221,"type":20},31,[24],"This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.",[160,27],"2026-05-13",{"date":227,"type":36},"2026-05-18",{"date":225,"type":36},{"date":230,"type":20},"2036-05-13",{"name":232,"class":43},"Sara Medek",1,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":241,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":233},"100606184","phase-2-cue-101with-pembrolizumab-for-locally-advanced-hpvhnsccs-100606184","NCT07172256","CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs","A Pilot Study of CUE-101 in Combination With Pembrolizumab in Subjects With Newly Diagnosed, Locally Advanced HPV-16 Associated Head and Neck Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oropharynx (cT1-4 N0-N3 M0)\n* Participants must be deemed unresectable by a head and neck surgeon for one or more of the following reasons:\n\n  1. Inability to obtain a R0 resection with a minimally invasive surgical approach, such as Transoral Robotic Surgery (TORS)\n  2. Risk of significant functional deficit with a surgical treatment approach\n  3. Other anatomical (such as retropharyngeal location of the carotid artery) or tumor characteristics that in the surgeon's judgment would be a contra-indication to a minimally invasive surgical approach.\n* Participants with newly diagnosed HNSCC who underwent partial surgical resection and have gross residual disease are eligible for the study if additional treatment is required.\n* Participant must have a tumor that is HPV-16 positive and express p16INK4A. Archival tissue or formalin fixed, paraffin-embedded (FFPE) tissue from a biopsy and\u002For surgery must be available for HPV-16 and p16INK4A testing on all participants enrolled. All tumors must test positive for HPV-16 using ISH analysis or using HPV16 specific PCR testing and p16INK4A expression in tumor cells using IHC analysis.\n* Archival tissue or formalin fixed, paraffin-embedded (FFPE) tissue from a biopsy and\u002For surgery must be available for PD-L1 staining. Tumors must be scored for CPS.\n* Participants must have HLA-A\\*0201 genotype as determined by genomic testing.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) for non-nodal lesions and \\> 15mm (\\>1.5 cm) for nodal lesions with CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam. See section 11 (Measurement of Effect) for the evaluation of measurable disease.\n* Age ≥18 years. Since no dosing or adverse event data are currently available on the use of CUE-101 alone or in combination with pembrolizumab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status of 0 or 1 (Karnofsky ≥60%, see Appendix A).\n* Participants must have adequate organ and marrow function as defined below in the protocol\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* A male participant must agree to use of a highly effective method of contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) as defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal or\n  2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n  3. Highly effective methods of contraception:\n\n  i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal.\n\nii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable.\n\niii. Non-hormonal (copper) intrauterine device. iv. Intrauterine hormone-releasing system. v. Bilateral tubal occlusion\u002Fligation. vi. Sexual abstinence, i.e., refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant).\n\nvii. Vasectomized sexual partner (provided that partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has received medical assessment of the surgical success).\n\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Has distant metastases or radiographically detectable (even if asymptomatic and\u002For previously treated) central nervous system metastases and\u002For carcinomatous meningitis as assessed by local site investigator and radiology review.\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Participants who received prior radiotherapy treatment or systemic anticancer therapy including any other investigational agents for the HNC under study prior to first dose of study drug.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug.\n* History of allergic reactions attributed to compounds of similar chemical or biologic. composition to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-101 or pembrolizumab.\n* Participants with any history of known or suspected autoimmune disease with the specific exceptions of the following:\n\n  1. Vitiligo.\n  2. Resolved childhood atopic dermatitis.\n  3. Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).\n  4. Participants with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.\n* History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.\n* Treatment with corticosteroids (\\>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 7 days prior to the first dose of study drug administration. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed. Physiological replacement with hydrocortisone up to a maximum dose of 10 mg per day is allowed.\n* History of clinically significant cardiovascular disease including:\n\n  1. Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug.\n  2. Clinically significant cardiac arrhythmias.\n  3. Uncontrolled hypertension: systolic blood pressure (BP) \\> 180 mmHg, diastolic BP \\>100 mmHg.\n  4. Deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack within the 16 weeks prior to the initiation of study drug.\n  5. QTcB prolongation \\> 480 msec.\n  6. Congestive heart failure (New York heart Association class III-IV).\n  7. Pericarditis\u002Fclinically significant pericardial effusion.\n  8. Myocarditis.\n* Clinically significant pulmonary compromise (e.g., requirement for supplemental oxygen)\n* Clinically significant GI disorders including:\n\n  1. History of GI perforation within 1 year prior to study drug administration. Participants with a history of GI perforation that occurred more than 1 year ago can only be enrolled if the sponsor-investigator no longer considers the previously affected area to be at risk for perforation.\n  2. History of clinically significant GI bleeding within 3 months prior to the initiation of study drug.\n  3. History of acute pancreatitis within 3 months prior to the initiation of study drug.\n  4. Diverticulitis that is clinically significant in the opinion of the sponsor-investigator based on the extent or severity of known disease and\u002For the occurrence of clinically significant disease flares within four weeks prior to the initiation of study drug administration.\n* Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within seven days prior to the initiation of study drug. Participants requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than 1 week prior to the initiation of study drug\n* Second primary invasive malignancy that has not been in remission for \\> 2 years. Exceptions that do not require a 2-year remission include: non-melanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score \\\u003C6); or resected melanoma in situ.\n* History of trauma or major surgery within 4 weeks prior to first dose of study drug.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed.\n* Has Grade \\> 2 audiometric hearing loss. Note: Audiometric abnormalities without corresponding clinical symptoms of Grade \\> 2 hearing loss will not be grounds for exclusion.\n* Has Grade \\> 2 neuropathy.\n* Has Grade \\> 2 bleeding due to the underlying malignancy.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Active or history of alcohol or other substance abuse within 1 year prior to the initiation of study drug administration.\n* Participants with uncontrolled intercurrent illness.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, as determined by the treating investigator.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Any investigative site personnel directly affiliated with this study.\n* Prisoners or other individuals who are involuntarily detained.\n* Pregnant women are excluded from this study because it is unknown whether CUE-101 and\u002For pembrolizumab is an agent with the potential for teratogenic or abortifacient effects. It is unknown whether pembrolizumab is excreted in human milk. Since many drugs are excreted in human milk, and because of the potential for serious adverse reactions in the nursing infant, participants who are breast feeding are not eligible for enrollment.",true,{"count":243,"type":20},30,[24],"This is a phase 2, pilot, randomized, open-label 3-arm study to assess the safety, tolerability, and efficacy of CUE-101 monotherapy, and CUE-101 in combination with pembrolizumab as neoadjuvant therapy in HLA-A\\*0201-positive treatment naive participants with locally advanced HPV-16 associated head and neck squamous cell carcinoma (HNSCC).",[201,27,247,248],"New Diagnosis Tumor","Locally Advanced","2026-05-10",{"date":225,"type":36},{"date":252,"type":36},"2026-05-07",{"date":254,"type":20},"2031-02",{"name":256,"class":43},"Yale University",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":277,"leadSponsor":279,"locationsCount":233},"100636442","phase-1-intranasal-wsk-im05-vaccine-plus-tislelizumab-as-neoadjuvant-therapy-for-hpv-opscc-100636442","NCT07565740","Intranasal WSK-IM05 Vaccine Plus Tislelizumab as Neoadjuvant Therapy for HPV+ OPSCC","A Prospective, Single-Arm Clinical Study of Intranasal Recombinant Adenovirus Vaccine WSK-IM05 Combined With Tislelizumab as Neoadjuvant Therapy for HPV-Positive Oropharyngeal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1\\. Age ≥ 18 years, male or female.2. Histologically confirmed oropharyngeal squamous cell carcinoma meeting all of the following criteria: Newly diagnosed, HPV-positive, without distant metastases; Confirmed p16 positive by immunohistochemistry (defined as ≥70% moderate to strong nuclear and cytoplasmic staining of tumor cells)；Assessed by head and neck surgery as resectable; Willing to undergo surgical treatment.3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.4. Adequate organ and bone marrow function, defined as:Hematology: neutrophil count (NEUT) ≥ 1.5×10⁹\u002FL; platelet count (PLT) ≥ 80×10⁹\u002FL; hemoglobin ≥ 8 g\u002FdL; Liver function: AST, ALT, ALP ≤ 2.5×upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5×ULN; Albumin ≥ 2.8 g\u002FdL.Renal function: serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (CCr) \\> 60 mL\u002Fmin; Coagulation: international normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Adenovirus type 5(Ad5) neutralizing antibody titer ≤ 1:200.5. Willing to voluntarily sign the informed consent form and able to comply with protocol-required visits and procedures.\n\nExclusion Criteria:\n\n1\\. History of other malignancies (except for adequately treated and with no recurrence within 5 years:basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer,cervical carcinoma in situ, intramucosal gastrointestinal carcinoma, or other malignancies deemed eligible by the investigator).2. Any active autoimmune disease or history of autoimmune disease,including but not limited to immune-related neurological disorders, multiple sclerosis, autoimmune(demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus(SLE), connective tissue disease, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type I diabetes mellitus managed with stable insulin doses).3. History of allergic disease, severe drug allergy, or known allergy to any component of large molecule protein preparations,PD-1 monoclonal antibody injections, or the intranasal recombinant adenovirus vaccine (note: severe allergy is defined as requiring hospitalization).4. Prior receipt of any of the following treatments:a. Prior use of PD-1 antibody, PD-L1 antibody, PD-L2 antibody, CTLA-4 antibody, EGFR antibody, or EGFR-TKI.b. Prior receipt of an antitumor vaccine.c. Use of any active vaccine against infectious diseases (e.g.,inffuenza vaccine, varicella vaccine) within 4 weeks before first dose or planned during the study period.d. Major surgery or severe trauma within 4 weeks before first dose.e. Prior antitumor toxicity not recovered to ≤ CTCAE v5.0 grade 1 (excluding alopecia or sequelae of prior platinum-related neuropathy) or to the levels specified in inclusion\u002Fexclusion criteria.5. Presence of severe medical conditions, such as: Cardiac dysfunction grade II or higher (NYHA criteria), ischemic heart disease (e.g., myocardial infarction or angina), clinically significant supraventricular or ventricular arrhythmias; Poorly controlled diabetes (fasting blood glucose ≥ 10 mmol\u002FL); Poorly controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg); Echocardiography showing ejection fraction \\\u003C 50%; QTc interval: \\> 450 msec in males, \\> 470 msec in females; Any ECG abnormality that, in the investigator's opinion, poses additional risk for the study drug.6. History of interstitial lung disease, non-infectious pneumonitis, or high suspicion of interstitial lung disease; or conditions that might interfere with detection or management of suspected drug-related pulmonary toxicity. Patients with a prior history of drug-induced or radiation-induced non-infectious pneumonitis who are asymptomatic may be enrolled. Active tuberculosis or past tuberculosis that remains uncontrolled after treatment.7. Patients with hyperthyroidism or organic thyroid disease. Hypothyroidism managed with a stable dose of thyroid replacement hormone may be enrolled (as conffrmed by the investigator and\u002For endocrinologist).8. Active infection, or unexplained fever within 48 hours before first dose, or use of systemic antibiotics within 1 week before signing informed consent.9. Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10⁴ copies\u002FmL) or active hepatitis C (positive HCV antibody with HCV RNA above the lower limit of detection), or known positive HIV test or known acquired immunodeffciency syndrome (AIDS).10. Clear history of neurological or psychiatric disorders, such as epilepsy or dementia.11. Clear history of drug abuse or alcohol abuse within 3 months.12. Pregnant or breast feeding women; participants (and their partners) who plan to conceive within 3 months after the study period, have unprotected sexual intercourse, or are unwilling to use adequate contraceptive measures (e.g., condom,intrauterine device, or partner sterilization).13. Receipt of any investigational drug within 4 weeks before first dose, or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.14. Any other condition that,in the investigator's judgment, might interfere with the study, including inability to complete study treatment and follow-up.",{"count":265,"type":20},9,[23],"This phase I, open-label, single-arm trial uses a \"3+3\" dose-escalation design to evaluate the safety, tolerability, and preliminary efffcacy of intranasal WSK-IM05 vaccine combined with tislelizumab as neoadjuvant therapy in patients with resectable HPV-positive oropharyngeal squamous cell carcinoma. Participants receive two cycles of WSK-IM05 (intranasal) and tislelizumab (200 mg IV) on day 1 of each 3-week cycle, followed by surgery. After surgery, patients receive standard of care (chemoradiotherapy or radiotherapy as indicated) plus 15 cycles of adjuvant tislelizumab. The main outcomes include dose-limiting toxicities and treatment-related adverse events.",[159],[162,270,271,272],"Neoadjuvant therapy","PD-1 inhibitor","Pathological response","2026-05-06",{"date":275,"type":36},"2026-05-11",{"date":249,"type":20},{"date":278,"type":20},"2028-05-10",{"name":280,"class":43},"West China Hospital",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":287,"targetDuration":289,"studyType":290,"phases":4,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":233},"100485420","de-escalated-radiation-for-human-papillomavirus-positive-squamous-cell-carcinoma-of-the-oropharynx-100485420","NCT05600842","De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven (from primary lesion and\u002For lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status.\n* Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible;\n* History\u002Fphysical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss;\n* Age ≥ 18;\n* PET\u002FCT within 6 weeks prior to registration;\n* Patients must sign a study-specific informed consent form prior to study entry.\n* Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.\n\nExclusion Criteria:\n\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;\n* Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded;\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Receipt of prior radiotherapy that would result in overlap with proposed field.",{"count":288,"type":20},111,"2 Years","OBSERVATIONAL","This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.",[27],"2026-04-29",{"date":295,"type":36},"2026-05-05",{"date":297,"type":36},"2022-11-03",{"date":299,"type":20},"2026-11",{"name":301,"class":43},"University of California, Irvine",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":310,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100462919","phase-2-a-study-on-using-cell-free-tumor-dna-ctdna-testing-to-decide-when-to-startroutine-treatment-in-people-with-human-papilloma-virus-hpv--associated-oropharynx-cancer-opc-100462919","NCT05307939","A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)","Phase II Trial Evaluating Selective Minimal Residual Disease Directed Adjuvant Radiation in Human Papilloma Virus Associated Oropharynx Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18\n* ECOG 0-2\n* HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization.\n* HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies\u002FmL pre-operatively.\n* Surgical resection of all gross disease with no gross disease visualized on post-operative imaging.\n\n  o For patients with pT0 (unknown primary) evaluation for the primary should include PET\u002FCT, direct laryngoscopy, ipsilateral tonsillectomy, and targeted biopsy. This should be followed by a neck dissection.\n* Two, undetectable (\\\u003C1 copy\u002FmL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred).\n* A minimum of one of the following pathologic criteria: (Arm A)\n\n  * AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3\n  * AJCC 7 ≥pN2\n  * Lymphovascular invasion\n  * Perineural invasion\n  * Close pathologic margin (≤ 3 mm)\n* Signed informed consent form by the participant or their legally authorized representative (LAR).\n* A minimum of one of the following pathologic criteria (Arm B):\n\n  * Microscopic positive margin\n  * Extracapsular extension\n* Signed informed consent form by the participant or their legally authorized representative (LAR).\n\nAdditional criteria for Arm B only:\n\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * White Blood Count (WBC) ≥ 2 K\u002FmcL\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula:\n  * CCr male = \\[(140 - age) x (wt in kg)\\] divided by \\[(Serum Cr mg\u002Fdl) x (72)\\]\n  * CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  \\- Bilirubin \\\u003C 2 mg\u002Fdl o AST or ALT \\\u003C 3 x the upper limit of normal\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n\nExclusion Criteria:\n\n* Metastatic disease\n* Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)\n* Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI\u002Fco-PI\n* Prior head and neck radiation\n* Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies\u002FmL\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  o Note: Exceptions can be made for patients with simultaneous primaries outside of the oropharynx if determined by the PI\u002FCo-PI, then the patient can proceed with protocol activities\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater\n\n  o Note: Exceptions can be made for patients with prior invasive malignancy if determined by the PI\u002FCo-PI, then the patient can proceed with protocol activities\n* Prior systemic chemotherapy for the study cancer\n\n  o Note: prior chemotherapy for a different cancer is allowable\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.",{"count":243,"type":20},[24],"This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery.\n\nIn Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable.\n\nIn Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.",[86,58,65,64,27],[314,315,316,317,318],"ctDNA","NavDx test","21-434","HPV-OPC","Memorial Sloan Kettering Cancer Center","2026-04-10",{"date":321,"type":36},"2026-04-13",{"date":323,"type":36},"2022-03-24",{"date":325,"type":20},"2027-03-24",{"name":318,"class":43},8,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":21,"phases":337,"briefSummary":338,"conditions":339,"keywords":350,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},"100597801","phase-2-a-study-of-sacituzumab-govitecan-in-combination-with-cetuximab-in-people-with-head-and-neck-squamous-cell-cancer-hnscc-100597801","NCT07063212","A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)","A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion.\n\n  * Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and\u002For radiation based approaches\n  * Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial\n  * HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I.\n  * Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if they are measurable and progression has been demonstrated in these lesions.\n* Male or female patients 18 years of age or older on the day of consent.\n* ECOG Performance Status of 0 to 1.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  o Serum creatinine \\\u003C 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr)\n\n  ≥ 30 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN.\n  * AST and ALT \\\u003C 2.5 x the upper limit of normal\n  * Albumin ≥ 3 g\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n* Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.\n* Female patients are eligible to participate if they are not pregnant, not breastfeeding and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential\n  * A woman of childbearing potential who agrees to use highly effective contraception from signing of the ICF through six months after the last study treatment administration.\n\nNotes:\n\ni. Female of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year. ii. Highly effective contraception methods include:\n\n* Total abstinence\n* Male or female sterilization\n* Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3):\n\n  * Category 1: Use of oral, injected, or implanted hormonal methods of contraception.\n  * Category 2: Placement of an intrauterine device or intrauterine system.\n  * Category 3: Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * A female participant who is of childbearing potential must have a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test within 72 hours prior to the first administration of study treatment or be surgically\u002Fbiologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal. Note: Postmenopausal females are defined as those who are:\n* Age \\> 50 years with amenorrhea for ≥ 12 months.\n* Age ≤ 50 years with six months of spontaneous amenorrhea and follicle stimulating hormone level within postmenopausal range (\\> 40 mIU\u002FmL).\n\n  * Male patients must agree to use contraception and refrain from sperm and egg donation from the time period between signing of the ICF and through five months after the last dose of study drug\n  * The subject must provide voluntary study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent\u002Fmetastatic setting.\n\n  o Ambiguity regarding lines of treatment a patient has received will be subject to PI review and approval.\n* Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and\u002For consultation with allergy\u002Fimmunology.\n* Patients who have previously received topoisomerase I inhibitors for HNSCC\n* Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome\n* Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.\n* Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.\n\n  * Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this criterion and may qualify for the study.\n  * Note: If subjects underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study drug.\n  * Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis which must be recovered, \\\u003C Grade 1) related to immunotherapy and\u002For radiation treatment that are long lasting, but stable on treatment and not requiring agents that are excluded by this protocol may qualify for the study.\n* Patients with simultaneous primary cancers aside from HNSCC will be excluded unless otherwise approved by PI.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI\n* Severe, active co-morbidity defined as the following:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute infection requiring intravenous therapy at the time of registration\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defect\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain metastases and are taking ≤ 20 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.\n* Known acquired immunodeficiency syndrome due to untreated\u002Fpoorly controlled human immunodeficiency virus. Other diagnosed immunodeficiency syndromes or disorders will require the review and approval of the site PI.\n* Positive test for hepatitis B surface antigen (HBsAG) or hepatitis C virus antibody (anti-HCV), indicating acute or chronic infection. Patients who test positive for anti-HCV but negative for HCV ribonucleic acid (RNA) are permitted to enroll.\n* Herbal remedies known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise between the PI and treating investigator.\n* Female patients who are pregnant, breastfeeding, or plan on becoming pregnant during the study.",{"count":336,"type":20},40,[24],"The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and\u002For metastatic head and neck squamous cell cancer (HNSCC).",[340,341,342,343,58,344,345,346,347,348,349,27],"Squamous Cell Carcinoma of Head and Neck","Sinus Cancer","Nasal Cavity Cancer","Oral Cavity Cancer","Hypopharynx Cancer","Larynx Cancer","Oral Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma",[340,341,342,343,58,344,345,346,347,348,349,27,351,352,318],"Sacituzumab Govitecan","25-094","2026-02-17",{"date":355,"type":36},"2026-02-19",{"date":357,"type":36},"2025-07-02",{"date":359,"type":20},"2028-01-02",{"name":318,"class":43},7,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":21,"phases":371,"briefSummary":372,"conditions":373,"keywords":383,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":4},"100625084","phase-2-a-single-arm-phase-ii-trial-in-p16-positive-oropharynx-cancer-of-selective-dose-de-escalation-of-nodal-volumes-at-minimal-risk-and-primary-site-disease-saved-100625084","NCT07418034","A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)","SAVED","4.1 Step 1 Registration 4.1.1 Step 1 Inclusion\n\n(Y) 1. Is there pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n\n(Y) 2. Is the patient ≥ 18 years of age?\n\n(Y) 3. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\n(Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):\n\nTORS candidate patients must be:\n\n• cT0-4 and N0, N1, N3\n\nNon-TORS candidate patients must be either:\n\n* cT1-4 N0, N1, N3\n* cT1-3 N2 with \\\u003C 10 pack years\n\n4.1.2 Step 1 Exclusion\n\n(N) 1. Patient who are clinical N2 and have ≥10 pack years smoking history\n\n(N) 2. Patients who are clinical T4N2\n\n(N) 3. Patients with distant metastasis (M1)\n\n4.2 Step 2 Registration 4.2.1 Step 2 inclusion\n\n(Y) 1. Does the patient have pathologically (histologically or cytologically) proven P16+ status?\n\n(Y) 2. Does the patient have appropriate imaging (PET\u002FCT preferred, CT neck with IV contrast and CT chest without contrast as recommended alternative to PET\u002FCT) completed within 90 days of enrollment?\n\n(Y) 3. Does the patient have clinical or pathological M0 staging? (Y) 4. Patients who have undergone TORS must have pathological stage pT1-4 N0, N1 or N3. TORS patients found to be clinical N2 post TORS or have contralteral neck dissection and positive nodes will be excluded.\n\n(Y) 5. Is the patient a candidate for bilateral radiation based on evaluation by ENT, Rad Onc, or Med Onc and review at multi-disciplinary tumor board?\n\n(Y) 6. Non-TORS patients who are cT1-3 N0, N1, N2 and have \\\u003C10 PY must have completed a ctDNA evaluation prior to Step 2 enrollment.\n\n(Y) 7. Non-TORS patients who are cT1-3 N2 must have a positive ctDNA result prior to Step 2 enrollment.\n\n(Y) 8. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n\n(Y) 9. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n\n(Y) 10. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n\n4.2.2 Step 2 Exclusion\n\n(N) 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n\n(N) 2. Does the patient have distant metastasis?\n\n(N) 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low\u002Fintermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n\n(N) 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n\n(N) 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n\n(N) 6. Did the patient have prior cancer-related surgeries of curative intent of the head and neck excluding superficial removal of cutaneous skin malignancies?\n\n(N) 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n\n(N) 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n\n(N) 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?",{"count":370,"type":20},132,[24],"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care.\n\nStudies have reported that lowering radiation doses for some patients can reduce side effects while still effectively controlling the cancer.\n\nPatients with this type of head and neck cancer typically receive either surgery or radiation as their first treatment.\n\nFor patients who receive surgery first, radiation to the surgical area and nearby neck lymph nodes is often recommended afterward. In these patients, the study will test whether lowering the radiation dose to low-risk lymph nodes on the side of the neck opposite the tumor can reduce side effects while still effectively controlling the cancer (Method A).\n\nFor patients who receive radiation as their first treatment, the study will test one or both of two radiation approaches aimed at reducing both short-term and long-term side effects. These approaches include reduced lymph node radiation (Method A, described above) and a tumor dose reduction approach (Method B), which lowers the radiation dose delivered directly to the tumor.\n\nInformation such as tumor size, the number of cancerous or suspicious lymph nodes, and risk factors like smoking history will be used to determine which patients may be eligible for reduced lymph node radiation (Method A), reduced tumor radiation (Method B), or both. Patients who may qualify for tumor dose reduction (Method B), either alone or combined with Method A, will need an additional blood test called a circulating tumor DNA (ctDNA) test to determine eligibility.\n\nThe ctDNA test measures small amounts of tumor-related DNA in the blood, which are often elevated at the time of diagnosis. Studies have shown that cancer is more likely to return when ctDNA levels remain positive after treatment. This study will evaluate whether ctDNA levels measured before and during treatment can help identify patients who can safely receive lower radiation doses to the tumor (Method B).\n\nOverall, this study aims to safely evaluate two radiation de-escalation approaches in order to lessen short- and long-term side effects while maintaining excellent cancer control.",[186,374,201,375,376,377,160,378,379,380,381,27,29,382],"Head and Neck Squamous Cell Cancer","Oropharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma (OPSCC)","Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma (SCC)","Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Oropharyngeal Squamous Cell Cancer","HPV 16 Positive Oropharyngeal Tumors (OPC)",[384,186,58,385,386,387,388,314,389],"Transoral Robotic Surgery (TORS)","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","Radiation Therapy","P16 positive","2026-02-10",{"date":392,"type":36},"2026-02-18",{"date":394,"type":20},"2026-05",{"date":396,"type":20},"2033-05",{"name":398,"class":43},"University of Maryland, Baltimore",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":21,"phases":408,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":430},"100540678","phase-1-a-study-to-evaluate-lenti-hpv-07-immunotherapy-against-hpv-cervical-or-oropharyngeal-cancer-100540678","NCT06319963","A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer","An Open-Label Phase 1\u002F2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer","Inclusion Criteria:\n\n* histologically confirmed invasive HPV-related oropharyngeal or cervical cancer\n* ECOG performance status of 0 or 1\n* adequate hepatic, renal, pulmonary, and bone marrow\u002Fhematological function\n\nExclusion Criteria:\n\n\\- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection",{"count":407,"type":20},72,[23,24],"The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).\n\nThe main questions aim to answer are:\n\n* Is Lenti-HPV-07 safe?\n* Does Lenti-HPV-07 induce an immune response?\n\nParticipants will be assigned to a group based on their cancer type\n\n* either study drug group A: recurrent and\u002For metastatic cancer\n* or study drug group B: newly diagnosed with locally advanced cancer\n\nAfter they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.",[66,27],[412,56,135,413,414,415,416,417,418,419,420],"HPV16","Immuno-oncotherapy","Head and Neck Cancers","T-cell vaccine","Lentiviral Vector","Anti-tumor immunity","Early E- and E7 antigens","HPV18","Human Papillomavirus","2026-01-29",{"date":423,"type":36},"2026-02-02",{"date":425,"type":36},"2024-08-08",{"date":427,"type":20},"2026-12",{"name":429,"class":211},"Theravectys S.A.",4,{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":21,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":233},"100302329","phase-2-adaptive-treatment-de-escalation-in-favorable-risk-hpv-positive-oropharyngeal-carcinoma-100302329","NCT03215719","Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma","Adaptive De-escalation of Radiation Therapy Dose in HPV-Positive Oropharyngeal Carcinoma (ART) Demonstrating Favorable Mid-Treatment Response","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which include the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.\n* If the primary site is biopsied, Patient's tissue must be positive for p16 by immunohistochemical staining (\\>70% staining). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is not available for p16 immunohistochemistry.\n* Patients must have detectable HPV ctDNA Score Report at Screening or have a detectable baseline HPV ctDNA Score Report (Naveris test) if no primary site is biopsied. Must have detectable screening plasma HPV DNA (also referred to as ctHPV DNA).\n* Clinical stage T1-T3, N1-N2b (AJCC 7th Edition) with no distant metastases based on the following diagnostic workup:\n* Fiberoptic exam with laryngopharyngoscopy (mirror and\u002For fiberoptic and\u002For direct procedure) within 8 weeks prior to registration.\n* One of the following combinations of imaging is required within 8 weeks of registration:\n\n  1. CT scan of the neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast);\n  2. Or an MRI of the neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast)\n  3. Note: A CT scan of the neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as both staging and planning tools.\n* Patients must provide their personal smoking history prior to registration. Patients cannot have a cumulative personal smoking history that exceeds 10 pack-years.\n\n  1. Number of pack-years = \\[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\\] \u002F 20\n  2. Note: Twenty cigarettes is considered equivalent to one pack. Cigar and pipe tobacco consumption is not included in calculating lifetime pack-years.\n* Zubrod Performance Status of 0-1 within 8 weeks prior to registration;\n* Adequate hematologic function within 2 weeks prior to registration, defined as follows:\n\nAbsolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3; Platelets ≥ 100,000 cells\u002Fmm3; Hemoglobin ≥ 8.0 g\u002Fdl; Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.\n\n* Adequate renal function within 2 weeks prior to registration, defined as follows:\n\n  a.Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin determined by 24 hour collection or estimated by Cockcorft-Gault formula: i.CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] ii.CCr female = 0.85 x (CrCl male)\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;\n* Patients who are HIV positive but who have no prior AIDS-defining illness and have CD4 cells of at least 350\u002Fmm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).\n* The patient must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Missing or undetectable baseline plasma HPV DNA level\n* Cancers considered to be from an oral cavity site (oral tongue, floor of mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;\n* Carcinoma of the neck of unknown primary site origin (even if p16 positive);\n* Distant metastasis or adenopathy below the clavicles;\n* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.\n* Simultaneous primary cancers or separate bilateral primary tumor sites;\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Severe, active co-morbidity defined as follows:\n\n  1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n  2. Transmural myocardial infarction within the last 6 months;\n  3. Acute bacterial or fungal infection intravenous antibiotics at the time of registration;\n  4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;\n  5. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those listed in 4.1.10.\n  6. Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition with immune compromise greater than that noted in section 4.1.12; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients.\n* Pregnancy; this exclusion is necessary because the treatment in this study may be significantly teratogenic\n* Prior allergic reaction to cisplatin.\n* Exclusion Criteria for MRI: Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.\n* Electrical implants such as cardiac pacemakers or perfusion pumps\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants\n* Ferromagnetic objects such as jewelry or metal clips in clothing\n* Claustrophobia\n* History of seizures\n* Patients with GFR \\\u003C 15 ml\u002Fmin\u002F1.73m2 or who are on dialysis will not have DCE-MRI scan. These patients will have conventional anatomical MRI without contrast.",{"count":439,"type":20},120,[24],"This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.",[375,27],[388],"2026-01-02",{"date":446,"type":36},"2026-01-06",{"date":448,"type":36},"2017-10-18",{"date":450,"type":20},"2028-12",{"name":452,"class":43},"NYU Langone Health",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":466,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":475},"100522881","phase-2-selective-adjuvant-therapy-for-hpv-mediated-oropharynx-sccs-based-on-residual-circulating-tumor-dna-levels-saval-100522881","NCT06088381","Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)","A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)","SAVAL","Inclusion Criteria\n\n1. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or p16+ squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n2. Does the patient have clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET\u002FCT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET\u002FCT) with imaging within 60 days of enrollment?\n3. Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue?\n4. Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary tumor board?\n5. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n6. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n7. Is the patient ≥ 18 years of age?\n8. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n9. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\nExclusion Criteria\n\n1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n2. Does the patient have distant metastasis?\n3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low\u002Fintermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n6. Did the patient have prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies?\n7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?",{"count":462,"type":20},61,[24],"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment.\n\nThe goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.",[186,201,58,347,27],[384,186,58,385,386,387],"2025-11-05",{"date":469,"type":36},"2025-11-10",{"date":471,"type":36},"2024-03-07",{"date":473,"type":20},"2030-12-18",{"name":398,"class":43},5,{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":16,"minAge":482,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":21,"phases":485,"briefSummary":486,"conditions":487,"keywords":498,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":147},"100431631","phase-2-risk-adapted-therapy-in-hpv-oropharyngeal-cancer-using-circulating-tumor-cthpv-dna-profile---the-react-study-100431631","NCT04900623","Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study","Inclusion Criteria:\n\n* Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study:\n* Subject must have histologically or cytologically confirmed, stage I, II, or III (N3 disease excluded), HPV associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging.\n\n  \\-- Patients with HPV-associated disease of unknown primary (cT0) are eligible\n* HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following:\n\n  * Immunohistochemical staining for p16 with ≥70% expression\n  * Confirmatory DNA testing (PCR or ISH) for high-risk subtype\n* Willing to provide blood and tissue from a diagnostic biopsy and blood samples before, during, and after treatment.\n* Detectable HPV ctDNA blood sample at baseline, prior to treatment, using the NavDx® assay that detects HPV subtype 16\n* Age 22 years or older\n* ECOG performance status ≤ 2\n* Participants should have adequate organ and marrow function if they are to receive chemotherapy (cisplatin, or carboplatin and paclitaxel) with radiation concurrently as determined by standard institutional guidelines and investigator preference (parameters suggested below).\n\n  * absolute neutrophil count (ANC) ≥ 1000\n  * platelet count ≥ 100,000\n  * total bilirubin of 1.5 or less\n  * creatinine of 1.6 or less (or a CrCl ≥50 mL\u002Fmin) per institutional standards.\n* Planning to receive non-surgical management for HPV+ oropharyngeal cancer\n* Ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy. \"Women of childbearing potential (WOCBP)\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level above 40 mIU\u002FmL.\n* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.\n\nExclusion Criteria:\n\n* Patients with AJCC 2017 8th edition stage IVC (metastatic) disease; or patients with fixed cervical nodal disease suggesting extranodal extension or N3 disease as suggested by lymph nodes measuring \\>6 cm.\n* Subject who has had prior radiation and\u002For chemotherapy for head and neck cancer.\n* Any history of oncologic surgical resection (transoral robotic surgery, TORS) or oncologic neck dissection prior to undergoing definitive RT or chemoradiation. Note: prior tonsillectomy as part of identification of the primary tumor site or biopsy and excisional nodal biopsy is\u002Fare acceptable provided the patient would be standardly treated to definitive treatment doses of therapy off protocol. Patients with HPV-associated unknown primary should not have undergone a neck dissection to be eligible.\n* Undetectable baseline HPV ctDNA result by NavDx® testing or detectable baseline HPV ctDNA result for subtypes 18, 31, 33, or 35.\n* Pregnant or lactating women.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease is permitted if chance3 of recurrence is thought to be low.","22 Years",{"count":484,"type":20},145,[24],"This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test.\n\nThe names of the test and treatments involved in this study are:\n\n* NavDx® HPV ctDNA testing (HPV blood test)\n* Radiation therapy\n* Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)",[488,27,489,67,490,491,492,493,494,495,496,497],"HPV-Associated Oropharyngeal Squamous Cell Carcinoma","HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Stage","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage","HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Pathologic Stage",[488,27,497,496,495,494,493,492,491,490],"2025-07-28",{"date":501,"type":36},"2025-07-30",{"date":503,"type":36},"2021-07-02",{"date":505,"type":20},"2032-06-01",{"name":507,"class":43},"Jonathan Schoenfeld, MD, MPH",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":21,"phases":518,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":233},"100539682","de-escalation-of-radiation-dose-in-hpv-associated-opc-utilising-fmiso-pet-de-radiate-100539682","NCT06307015","De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)","De-escalation of Radiation Dose in HPV-associated Oropharyngeal Squamous Cell Carcinoma Utilising FMISO PET and Magnetic Resonance Imaging as Non-Invasive Biomarkers of Hypoxia (DE-RADIATE)","DE-RADIATE","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histologically confirmed cT1-2N1-2b oropharyngeal squamous cell carcinoma or cTxN1-2 carcinoma of unknown primary\n* p16 positive (70% nuclear and cytoplasmic staining) and HPV positive (genotyping via PCR) tumours of the tonsil, base of tongue, glossotonsillar sulcus, or unknown primary site (suspected mucosal origin).\n* No contraindications to radiotherapy, platinum-based chemotherapy or surgery\n* No contraindications to PET\u002FCT or MRI\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (KPS \\> 70%)\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study\n* Patients with a history of severe renal disease(s) (eGFR \\\u003C20) than cannot tolerate gadolinium chelate contrast agents.)\n* ECOG ≥ 3\n* Previous high dose radiation therapy to the head or neck\n* Patients unwilling or unable to have PET\u002FCT or MRI\n* Geographically remote patients unable to agree to imaging schedule\n* Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.\n* Patients with significant cardiac or pulmonary disease including cardiac arrythmias or Chronic Obstructive Pulmonary Disease (COPD) that are unable to tolerate high flow O2 for oxygen contrast.\n* Patients taking carbonic anhydrase inhibitors (acetazolamide)\n* History of glaucoma\n* Any implant, foreign body, 3T MRI incompatible device, or other contraindication to MRI imaging",{"count":517,"type":20},25,[519],"NA","The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy.\n\nThe main questions it aims to answer are:\n\n1. What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection?\n2. What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT?\n3. What are the acute and late toxicities in patients selected for radiation dose de-escalation?\n4. What are the quality of life scores in patients selected for radiation dose de-escalation?\n5. What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation?\n\nPatients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response.\n\nResearchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy).",[27],[523,524,525,526],"Radiation therapy","De-escalation","FMISO PET","Hypoxia","2025-07-25",{"date":501,"type":36},{"date":530,"type":36},"2025-04-01",{"date":532,"type":20},"2031-12",{"name":534,"class":43},"Royal North Shore Hospital",{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":21,"phases":543,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":147},"100471454","phase-2-the-sinai-robotic-surgery-trial-in-hpv-related-oropharyngeal-squamous-cell-carcinoma-sirs-20-trial-100471454","NCT05419089","The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed and identified resectable primary OPSCC with positive p16 immunohistochemistry, defined as strong and diffuse nuclear and cytoplasmic staining in \\> 70% of tumor cells. Immunohistochemistry must be performed or reviewed at the central laboratory. P16 status may be determined prior to consent and must be confirmed by surgical specimen if a biopsy is unavailable. HR-HPV status and postoperative cfHPVDNA testing must be performed and resulted prior to treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery.\n* Patients enrolled in the trial must have pre-surgery baseline cfHPVDNA using the NavDX assay (Naveris, Cambridge, MA). Detectable baseline cfHPVDNA copy number is defined as ≥ 10 fragments\u002FmL and is required for inclusion in the trial.\n* Undetectable cfHPVDNA after surgery. All patients should have a repeat cfHPVDNA test within 1 to 5 weeks post-operatively and prior to treatment assignment. Undetectable cfHPVDNA is defined as \\\u003C 5 fragments\u002FmL.\n* AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal extension.\n* Age ≥ 18 years at screening\n* No previous surgery, radiation therapy, or chemotherapy for head and neck cancer (other than excision\u002Fincisional biopsy of the primary site, excisional\u002Fincisional nodal biopsy, or tonsillectomy) is allowed at time of study entry.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No active tobacco use (≥1cigarette or cigarette-equivalent per day within the last 5 years) and no cumulative smoking history of \\>20 pack years. 1 cigar = 4 cigarette-equivalent exposure\n* Ability to understand and the willingness to sign a written informed consent document.\n* Participants must have adequate bone marrow, hepatic and renal functions as defined below:\n\n  * Platelet count ≥ 90 x 109\u002Fl.\n  * Hemoglobin ≥ 10 g\u002Fdl (may achieve by transfusion).\n  * Renal function: eGFR ≥ 50 ml\u002Fmin\n\nExclusion Criteria\n\n* Age \\\u003C 18 years at screening\n* Pregnant or breast-feeding women.\n* Previous or current malignancies at other sites, except for adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, prostate cancer treated with surgery\u002Fradiotherapy, ductal carcinoma in situ of the breast treated with surgery\u002Fradiotherapy, or other cancer curatively treated and with no current evidence of disease for at least 3 years.\n* Other serious illnesses or medical conditions including but not limited to:\n\n  * Unstable cardiac disease despite treatment or myocardial infarction within 6 months prior to study entry.\n  * History of significant neurologic or psychiatric disorders including severe dementia or poorly controlled seizures\n  * Active clinically significant uncontrolled infection\n  * Active peptic ulcer disease defined as unhealed or clinically active\n  * Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis\n  * Severe chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia within 12 months of diagnosis.\n  * Prior organ transplant\n  * Interstitial lung disease\n  * Concurrent treatment with any other anti-cancer therapy\n  * Participation in an investigational therapeutic drug trial within 30 days of study entry. Participation in additional investigational radiation studies will exclude participation in SIRS. Participation in non-therapeutic, non-oncologic investigational studies (i.e. pain control studies, nutritional studies, etc.) will be allowed amongst SIRS participants, provided there is no alteration of treatment planning, oncologic therapy, or surveillance, and additional studies comply with SIRS safety criteria and stopping rules as outlined in the SIRS protocol.\n  * Active hepatitis C by history\n* Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, unequivocal radiographic or clinical supraclavicular or matted metastatic disease, \\> 3 unequivocally radiographic pathologic cervical nodes.\n* Non-HR-HPV subtype on initial biopsy or final pathology.\n* 5 or more positive nodes, irrespective of size, on final pathology.\n* p16 or HPV negative OPSCC as determined by IHC and PCR or ISH, respectively.\n* Undetectable or \\\u003C 10 fragments\u002FmL baseline cfHPVDNA prior to surgery.\n* Autoimmune disease treated with chemotherapy agents or anti TNF agents within the last 2 years.\n* Detectable repeat cfHPVDNA 1-5 weeks postoperatively via the NavDX assay, defined as \\> 5 fragments\u002FmL.",{"count":542,"type":20},83,[24],"The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery (TORS) alone can result in cancer control and survival comparable to those previously reported with standard therapy. The protocol includes patients with only with low or intermediate pathologic risk factors following surgery with detectable pre-surgery cfHPVDNA and undetectable post-surgery cfHPVDNA.\n\nThe hope is that with this approach, the long-term complications from chemotherapy and radiation can be reduced.",[159],[163,547,548,549,550,86,551,314,552,553],"OPSCC","Human papillomavirus","Transoral robotic surgery","TORS","p16","circulating tumor DNA","cfHPVDNA","2025-06-10",{"date":556,"type":36},"2025-06-13",{"date":558,"type":36},"2022-07-12",{"date":560,"type":20},"2027-06",{"name":562,"class":43},"Icahn School of Medicine at Mount Sinai",{"id":564,"slug":565,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":16,"minAge":570,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":21,"phases":573,"briefSummary":574,"conditions":575,"keywords":578,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":4},"100577414","phase-1-a-phase-iiia-clinical-trial-to-investigate-bvac-e6e7-in-subjects-with-hpv-positive-hnscc-100577414","NCT06797986","A Phase I\u002FIIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC.","A Phase I\u002FIIa Clinical Trial to Investigate the Safety, Immunogenicity and Efficacy of BVAC-E6E7 in Subjects with HPV Type 16 And\u002For 18 Positive Unresectable Recurrent or Metastatic Head","Inclusion Criteria:\n\n1. Adult male and female aged 19 and above at the time of acquisition informed consent form.\n2. Patients who have agreed to provide blood and tissue samples during the clinical trial.\n3. Patients with Head and neck squamous cell carcinoma histologically confirmed as HPV type 16 or 18 positive \\* The biopsy results obtained during screening process or the genotyping (PCR, microarray test) results from stored tissue (formalin-fixed paraffin-embedded) prior to screening should be confirmed positive to HPV type 16 or 18.\n4. Patients who are histologically or cytologically diagnosed with recurrent\u002Fmetastatic Head and neck squamous cell carcinoma (excluding Nasopharyngeal carcinoma).\n5. Patients with at least one measurable or evaluable lesion confirmed by CT or MRI according to RECIST v1.1. \\[It can be considered as an evaluable lesion if the disease has progressed in the previously irradiated area.\\]\n6. Patients who meet one of the following criteria and have no available standard treatment due to contraindication, intolerance or refusal of administration.\n\n   ① Patients who have progressed or recurred the cancer during or after the completion of primary or subsequent platinum based palliative systemic chemotherapy to treat the recurrent or metastatic Head and neck cancer.\n\n   ② Patients who have confirmed the progression of cancer within 24 weeks after the final administration of immune checkpoint blocker (ICI) or completion of combination treatment including platinum agents with a radical purpose.\n\n   ③ Patients who are ineligible for platinum based chemotherapy due to contraindications, intolerance or refusal of administration of platinum based chemotherapy.\n7. Patients with ECOG performance status of 0 or 1\n8. Patients with at least a 3-month life expectancy.\n9. Male patients who has not received the vasectomy should agree usage barrier contraceptive method (i.e. condom) and agree to use appropriate contraception for themselves and their partners for at least 6 months after the completion of IP administration.\n\n   * Appropriate contraceptive method: absolute abstinence, hormone contraceptive agent with unknown drug-interaction (e.g. levonorgestrel intrauterine system (IUS) (Mirena) or Medroxyprogesterone) and surgical sterilization operation (Vasectomy, Bilateral salpingectomy and ligation, etc.). However, Intermittent abstinences (ovulation period, symptothermal method or late-ovulation) or Coitus interruptus are not considered as appropriate contraceptive method.\n\nExclusion Criteria:\n\n1. Patients with a history of malignant tumor, excluding Head and neck squamous cell carcinoma, within 3 years prior to the screening (However, patients who are judged by investigator to have been cured of Basal cell carcinoma (BCC) \u002F Squamous cell carcinoma (SCC) of the skin, localized prostate cancer, papillary thyroid cancer, or cervical intraepithelial neoplasia (CIN) are able to enroll.)\n2. Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.\n3. Patients having below cardiovascular disease at the time of the screening process.\n\n   ① Myocardial infarction or Unstable angina within 6 months prior to the first IP administration (baseline).\n   * Severe heart failure or congestive heart failure of class Ⅲ or higher according to the New York Heart Association (NYHA).\n\n     * Ventricular arrhythmia requiring treatment. ④ Severe conduction disorder (e.g. 3rd degree AV block) ⑤ Uncontrolled hypertension according to the judgement by investigator.\n4. Patients who have confirmed clinically significant symptoms or uncontrolled central nervous system, brain metastasis, or carcinomatous meningitis (However, patients who have not confirmed the progression disease for at least 4 weeks after central nervous system or metastatic brain treatment and have not required treatment using steroid or other meditation within 7 days prior to the IP administration can be enrolled.)\n5. Patients with a history or confirmed active immune disease (e.g. rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, or T cell lymphoma) after receiving systemic treatment (e.g. disease-modifying agent, corticosteroid or immunosuppressive drug) \\[However, alternative treatment (thyroxine, insulin, physiologic corticosteroid alternative treatment due to dysfunction of adrenal gland or pituitary gland) are not considered as systemic treatments.\\]\n6. Patients who are unable to collect the blood for production of the IP, according to the judgement of investigator, due to thromboembolism disease or bleeding diatheses.\n7. Patients with a positive human immunodeficiency virus (HIV) test result\n8. Patients with active hepatitis B or C according to the hepatitis B virus (HBV) and hepatitis C virus (HCV) test result.\n\n   ① Patients positive for HBsAg and HBV DNA.\n\n   ② Patients positive for anti-HCV and HCV RNA.\n9. Patients with autoimmune disease or history of chronic or recurrent autoimmune diseases.\n10. Patients with a history of organ transplantation.\n11. Hematopoietic stem cell transplantation (HSCT) patients.\n12. Patients who have confirmed severe or uncontrolled active inflammation within 12 weeks prior to screening process.\n13. Patients with a history of hypersensitivity to the components of IP.\n14. Patients who have administrated a leukocyte product within 12 weeks prior to screening process.\n15. Patients who have received chemotherapy, radiotherapy or targeted therapy within 4 weeks prior to baseline \\[However, patients who have not recovered to NCI-CTCAE v5.0 Grade 1 or baseline levels from chemotherapy-related toxicities. (excluding Alopecia and vitiligo), even after 4 weeks, are not eligible for enrollment.\\]\n16. Patients who have administrated live-vaccine or live attenuated vaccine within 4 weeks prior to baseline.\n17. Patients who have administrated immunosuppressant within 2 weeks prior to baseline. (However, usage corresponding to the following immunosuppressant is allowed.)\n\n    * Steroid for nasal cavity, aspiration, topical, or local site (e.g. Intra-articular injection)\n    * Prednisolone 10 mg\u002Fday or systemic corticosteroid at a physiologic dose that does not exceed the equivalent amount.\n    * Steroids used for pretreatment of hypersensitivity (e.g. pretreatment of CT)\n18. Patients who meet the following laboratory test standards in the screening test\n\n    * ANC \\\u003C 1,500\u002Fmm³\n    * Platelet count \\\u003C 75,000\u002Fmm³\n    * Hemoglobin \\\u003C 9.0 g\u002FdL (If the hemoglobin recovers above 9.0g\u002FdL during the screening period, the patient is eligible for enrollment. However, blood transfusions within 7 days before screening to meet that standard is not allowed.)\n    * Serum creatinine \\>1.5 × ULN\n    * Total bilirubin \\>1.5 × ULN\n    * AST or ALT \\>2.5 × ULN (If liver metastasis confirmed \\>5 × ULN)\n19. Pregnant or lactating women\n20. Patients who have administrated IP for other clinical trials or applied investigational device within 4 weeks before screening. \\[However, the patients who correspond to one of the following, even after 4 weeks, are not eligible for enrollment.\\]\n\n    ① Patients who have participated in a clinical trial of immune therapeutic vaccine within 1 year before the screening or in an immunotherapy clinical trial within 6 weeks before the screening.\n\n    ② Patients with adverse drug reaction of Grade 2 or higher clearly associated with a previously participated immunotherapy clinical trial.\n21. Patients who are not eligible to enroll in this clinical trial according to the judgement of investigator for any other reason.","19 Years",{"count":572,"type":20},37,[23,24],"BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. This clinical trial for BVAC-E6E7 consists of two phases: PhaseⅠfocuses on safety and tolerance to determine the maximum tolerated dose (MTD), while Phase Ⅱ evaluates its efficacy.",[576,577,27],"Head and Neck Squamous Cell Carcinoma (HNSCC)","HPV (human Papillomavirus)-Associated Carcinoma",[579,580,581],"HNSCC","BVAC-E6E7","HPV Type 16 and\u002For 18 Positive","2025-01-22",{"date":584,"type":36},"2025-01-29",{"date":586,"type":20},"2025-03",{"date":588,"type":20},"2027-03",{"name":590,"class":211},"Cellid Co., Ltd.",{"id":592,"slug":593,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":21,"phases":600,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":618},"100517390","phase-1-safety-and-efficacy-of-vb1016-and-pembrolizumab-in-patients-with-head-neck-squamous-cell-carcinoma-100517390","NCT06016920","Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma","A Phase 1\u002F2a, Open-label, Dose-finding Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 and Pembrolizumab in Patients with Unresectable Recurrent or Metastatic HPV16-positive Head-Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\nGENERAL REQUIREMENTS\n\n1. ≥18 years of age (or as per national legal age of trial consent, whichever is higher) at date of signing the informed consent form (ICF)\n2. Histologically or cytologically confirmed R\u002FM HNSCC, located in the oropharynx, considered incurable by local therapy and eligible for monotherapy with pembrolizumab\n3. HPV16 positivity of R\u002FM oropharyngeal HNSCC confirmed by designated central laboratory\n4. PD-L1 positivity (CPS ≥1) using the validated PD-L1 IHC 22C3 pharmDx (DAKO) assay.\n5. Primary tumor location in the oropharynx.\n6. At least 1 measurable lesion per RECIST 1.1\n\n   ORGAN FUNCTION\n\n   Overall function:\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1\n\n   Hematological function:\n8. Platelets ≥100 × 10\\^9\u002FL (100,000\u002FµL)\n9. Neutrophils (absolute neutrophil count \\[ANC\\]) ≥1.5 × 10\\^9\u002FL (1,500\u002FµL)\n10. Hemoglobin ≥5.6 mmol\u002FL (9.0 g\u002FdL)\n\n    Hepatic and hemostatic function:\n11. Bilirubin (BILI), total ≤1.5 × upper limit of normal (ULN) (except Gilbert syndrome, then direct BILI ≤2 × ULN) or direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN.\n12. Aspartate transaminase (AST) ≤ 2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n13. Alanine transaminase (ALT) ≤ 2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n14. Alkaline phosphatase ≤ 2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n15. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)\u002Factivated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants.\n\n    Renal function:\n16. Estimated glomerular filtration rate (eGFR) ≥45 mL\u002Fmin\u002F1.73 m\\^2 using the Cockroft-Gault formula\n\n    OTHER TRIAL REQUIREMENTS\n17. Female patients of childbearing potential: negative serum pregnancy test (≤72 hours)\n18. Female patients of childbearing potential must agree to use highly effective contraception throughout the trial (14 days prior to initiation of treatment for oral contraception), and for at least 120 days (according to the current version of the IB for pembrolizumab) after the last dose of pembrolizumab and up to 6 months after the last dose of VB10.16, whichever comes last.\n\n    Male patients must agree to use male condoms during intercourse throughout the trial, and up to 3 months after the last dose of VB10.16, and must refrain from sperm donation in the same period.\n19. Patients capable of giving informed consent must provide signed and dated written informed consent prior to initiation of any study-related procedures.\n\nExclusion Criteria:\n\nHNSCC DISEASE\n\n1. Has disease that is suitable for local therapy with curative intent\n2. Has progressive disease ≤6 months after completion of curatively intended concurrent chemoradiotherapy for locoregionally advanced R\u002FM oropharyngeal HNSCC\n3. Primary tumor site of the oral cavity, hypopharynx, larynx or nasopharynx (any histology)\n4. Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator\n\n   PRIOR, CONCURRENT, OR FUTURE INTERVENTIONS\n5. Has received prior palliative radiotherapy within 2 weeks of start of trial treatment or has a prior history of radiation pneumonitis\n6. Any prior investigational or approved systemic antineoplastic drug or invasive medical device (including ICIs), either as monotherapy or as part of a combination regimen administered in the R\u002FM HNSCC setting\n7. Prior solid organ or tissue transplantation (except corneal transplant)\n8. Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)\n9. Prior chimeric antigen receptor T (CAR-T) cell therapy\n10. Prior therapy with a monoclonal or bispecific antibody or antibody fragment (or other molecule with similar mechanism of action) that engages T-cells\n11. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of trial intervention\n12. Administration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine within 30 days prior to VB10.16 treatment start\n13. Prior administration with a therapeutic HPV16 vaccine\n14. Patients receiving systemic immunosuppression with immunosuppressive agents such as cyclosporine, azathioprine, methotrexate, or tumor necrosis factor alpha (TNF α) blockers for any concurrent condition\n15. Chronic administration of systemic corticosteroids: prednisone \\>10 mg daily (or dose equivalent)\n16. Administration of G-CSF\u002FGM-CSF or transfusions with red blood cells, platelets, or plasma components ≤2 weeks prior to VB10.16 treatment start\n17. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)\n18. Has received prior surgery within 4 weeks prior to treatment\n19. Any planned major surgery\n\n    PRIOR OR CONCURRENT MORBIDITY\n\n    Malignancy:\n20. Past or current malignancy other than inclusion diagnosis, except for:\n\n    * Malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for at least 3 years before screening and felt to be at low risk for recurrence by the treating physician\n    * Adequately treated breast ductal carcinoma in situ without evidence of disease\n    * Adequately treated cervical carcinoma in situ, without evidence of disease\n    * Adequately treated non-melanoma skin cancer without evidence of disease\n    * Adequately treated superficial or in situ carcinoma of the bladder without evidence of disease\n    * Prostatic intraepithelial neoplasia without evidence of prostate cancer\n\n    Hepatic and hemostatic function:\n21. Any current bleeding disorder, active bleeding, or bleeding diathesis\n\n    Cardiovascular function:\n22. Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia\n23. History of myocardial infarction ≤ 6 months prior to planned VB10.16 treatment start\n24. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg), despite optimal medical management\n25. Any other significant cardiac disease(s) that, in the opinion of the investigator, is\u002Fare clinically significant and\u002For unacceptable\n\n    Pulmonary function:\n26. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease\n\n    Immune system and infectious diseases:\n27. Primary immunodeficiency, other immunosuppressive disorder, and\u002For other causes of immunosuppression\n28. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n29. Has a known history of human immunodeficiency virus (HIV) infection.\n30. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n31. Any active, acute, or chronic infection that is uncontrolled and\u002For requires systemic treatment\n32. Known allergies, sensitivity, or intolerance to VB10.16 (active substance or to any of the excipients), pembrolizumab (active substance or to any of the excipients), or aminoglycosides (especially kanamycin).\n\n    Central nervous system (CNS) function:\n33. Any history of intracerebral arteriovenous malformations, cerebral aneurysm, or stroke\n34. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during trial screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of trial treatment\n35. New (≤6 months), progressive and\u002For symptomatic brain metastases\n\n    OTHER\n36. Is currently participating in or has participated in a trial of an investigational agent or device in the R\u002FM setting.\n37. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the trial or interfere with the patient's participation for the full duration of the trial, such that it is not in the best interest of the patient to participate, in the opinion of the treating investigator\n38. Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the trial\n39. Has a concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, would contraindicate administration of VB10.16 and tumor biopsies\n40. Female patients who are pregnant or breastfeeding",{"count":599,"type":20},51,[23,24],"This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab. The goal of this part is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. In the second part of the trial, a phase 2a, dose expansion part, participants will receive either the highest safe dose of VB10.16 from part 1 or the 3 mg dose both in combination with pembrolizumab. The dose given to each participant will be decided in random.\n\nThe trial is designed to define the optimal dose of VB10.16 in combination with pembrolizumab for future clinical studies based on the safety, tolerability and anti-tumor effect data generated.",[27,579],[604,605,606,607,608],"Unresectable","recurrent","metastatic","HPV16 positive","PD-L1","2024-12-12",{"date":611,"type":36},"2024-12-17",{"date":613,"type":36},"2023-12-19",{"date":615,"type":20},"2028-01",{"name":617,"class":211},"Nykode Therapeutics ASA",17,{"id":620,"slug":621,"hasResults":11,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":21,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":111},"100560570","phase-2-surgery-and-reducing-ionizing-radiation-of-the-unknown-primary-100560570","NCT06578871","Surgery and Reducing Ionizing Radiation of the Unknown Primary","Surgery for the Unknown Primary in the Era of p16-positive Oropharyngeal Squamous Cell Carcinoma: Reducing Ionizing Radiation (SUPERIOR): A Randomized Trial","SUPERIOR","Inclusion criteria for the Registration phase\n\n* p16 positive PUK SCC of the neck\n* Age 18 years or older\n* Willing to provide informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Clinical nodal stage N1, AJCC 8th edition (i.e. clinical unilateral nodal disease, none larger than 6 cm)\n* Complete clinical work-up, including CT neck, physical examination with nasopharyngoscopy, and PET\u002FCT, with no evidence of a primary tumor. The PET\u002FCT scan must be without focal metabolic activity concerning for a primary tumor, in the opinion of the nuclear medicine physician. Metabolic activity, particularly in the tonsils and base of the tongue which is within normal physiologic range, does not exclude participation.\n\nInclusion criteria for the Randomization phase\n\n* Completed ipsilateral tonsillectomy and base of tongue mucosectomy with no evidence of a primary tumor\n\n  o Note, patients who had a PET\u002FCT that was initially positive, and therefore not meeting criteria in 4.10, but panendoscopy with biopsies of the fluorodeoxyglucose (FDG)-avid areas do not show malignancy, can then be enrolled and would be returned the OR for a neck dissection prior to randomization\n* Ipsilateral nodal disease on pathology with no evidence of extranodal extension\n\nExclusion Criteria:\n\n* Radiological or pathological extra-nodal extension\n* Epstein-Barr Virus (EBV)-positive\n* Clinical nodal stage (i.e. before neck dissection) N2-3, AJCC 8th edition (ie. bilateral nodes or node \\>6cm)\n* Pathological nodal stage (i.e. after neck dissection) pN3\n* Prior history of head and neck cancer within 2 years\n* Any other active invasive malignancy, except non-melanotic skin cancers, low-risk prostate cancer, and stage I-IVA papillary or follicular thyroid cancer\n* Known metastatic disease\n* Unable to complete QOL questionnaires\n* Pregnant or lactating women",{"count":628,"type":20},90,[24],"About 3% of people with head and neck cancer have cancer in their lymph nodes, but doctors are unable to find the primary tumour. This situation has become more common due to human papillomavirus (HPV), a virus linked to certain cancers. Generally, patients with HPV-related cancers have a good outlook, with around 90% surviving for at least five years.\n\nRecent advancements in medical technology, such as advanced imaging and specialized surgeries, have significantly improved doctors' ability to find these hidden tumours. These techniques can locate the primary tumour in 70-80% of cases. If the tumour remains undetected, it could be very small or potentially eliminated by the body's immune system.\n\nThe best way to treat this type of cancer is still debated. Current treatment options include surgery to remove lymph nodes or radiation therapy. There is no clear agreement on which areas should receive radiation. Often, surgery is performed on one side of the throat to try and locate the tumour's origin.\n\nResearchers are exploring ways to minimize the harmful side effects of treatment. Some studies suggest that surgery alone might be sufficient for patients with small tumours in their neck, but more research is needed. Another important question is whether radiation needs to cover the entire throat area. Recent findings suggest that omitting radiation from some areas might reduce side effects such as difficulty swallowing and dry mouth.\n\nThe SUPERIOR trial aims to investigate whether reducing the amount of radiation can still be effective and improve patients' quality of life. The study also examines whether surgery alone is adequate for certain patients with HPV-related cancers.",[201,27],[633,186,634,388,380,28,384,635,636],"HPV-Mediated PUK","P16+","Mucosal Radiation","SUPERIOR Trial","2024-08-29",{"date":639,"type":36},"2024-09-03",{"date":641,"type":20},"2025-01-01",{"date":643,"type":20},"2027-05-30",{"name":645,"class":43},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":647,"slug":648,"hasResults":11,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":21,"phases":656,"briefSummary":657,"conditions":658,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":233},"100396650","phase-2-testing-less-intensive-radiation-with-chemotherapy-to-treat-low-risk-patients-with-hpv-positive-oropharyngeal-cancer-100396650","NCT04444869","Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer","Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx \"ENID\"","ENID","Inclusion Criteria:\n\n* Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.\n* Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).\n* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.\n* Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.\n* Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:\n\n  * General history and physical examination within 30 days prior to registration;\n  * Fiberoptic exam with laryngopharyngoscopy (mirror and\u002For fiberoptic and\u002For direct procedure) within 60 days prior to registration;\n  * One of the following combinations of imaging is required within 45 days prior to registration:\n\n    1. A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast);\n    2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);\n    3. or a CT scan of neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast);\n    4. or an MRI of the neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast).\n\nNote: A CT scan of neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as both staging and planning tools.\n\n* Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.\n\nNumber of pack-years = \\[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\\] \u002F 20 Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined.\n\n* Zubrod Performance Status of 0-1 within 30 days prior to registration;\n* Adequate hematologic function within 14 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3;\n  * Platelets ≥ 100,000 cells\u002Fmm3;\n  * Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.\n* Adequate renal function within 14 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin\n* Adequate hepatic function within 14 days prior to registration defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002Fdl;\n  * AST or ALT \\\u003C 3 x the upper limit of normal.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n\nExclusion Criteria:\n\n* Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;\n* Carcinoma of the neck of unknown primary site origin (even if p16 positive);\n* T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.\n* Radiographically matted nodes, that span 6 cm or more; N3 disease\n* Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;\n* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;\n* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.\n* Simultaneous primary cancers or separate bilateral primary tumor sites;\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n  * Transmural myocardial infarction within the last 6 months;\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.",{"count":655,"type":20},28,[24],"This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.",[659,58,27,660],"Cancer of the Head and Neck","Throat Carcinoma","2024-05-16",{"date":663,"type":36},"2024-05-17",{"date":665,"type":36},"2020-09-28",{"date":667,"type":20},"2026-06",{"name":669,"class":43},"University of Missouri-Columbia"]