[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hpv-related-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hpv-related-squamous-cell-carcinoma":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,85,122,153,182,205,237,269],{"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":24,"conditions":25,"keywords":47,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983",false,"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.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"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 Positive Oropharyngeal Squamous Cell Carcinoma","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",[48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"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":75,"type":76},"2026-06-12","ACTUAL",{"date":78,"type":76},"2023-03-07",{"date":80,"type":20},"2027-01-01",{"name":82,"class":83},"Christian Hinrichs","OTHER",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"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":93,"type":20},15,[95,23],"PHASE1","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.",[98,35,34,39,38,41,37,43,44,45,42,26,28,29,99,32,31],"HPV-Associated Cervical Carcinoma","Vulvar Cancer",[57,101,102,103,104,105,106,49,60,52,107,108,109,110,111,112,113,114],"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":75,"type":76},{"date":117,"type":76},"2025-08-11",{"date":119,"type":20},"2026-10-01",{"name":82,"class":83},2,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100559388","phase-3-a-study-comparing-personalized-radiation-therapy-with-standard-radiation-therapy-in-people-with-hpv-positive-throat-cancer-100559388","NCT06563479","A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer","Phase III Randomized and Double-blinded Trial of De-escalated Radiation in FMISO PET-selected Good Risk Versus Standard of Care Radiation in Unselected HPV Positive Oropharyngeal Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown primary. Surgical removal of primary site is allowed.\n* Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc, Hayward, CA). Any CLIA certified testing method can be used.\n* Clinical stage Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET\u002FCT.\n* ECOG Performance Status of 0-1 or KPS \\>\u002F=70\n* Age ≥ 18\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) ≥ 1,500 cells\u002Fmm\\^3\n  * Platelets ≥ 100,000 cells\u002Fmm\\^3\n  * Hemoglobin ≥ 10.0 g\u002Fdl\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  o 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: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n* The patient must provide study-specific informed consent prior to study entry\n* Optional section of the protocol: Patients must be able to undergo MRI scans, i.e. not claustrophobic\n\nExclusion Criteria:\n\n* Patients with prior head and neck radiation therapy where there is \\>30% overlap with the current head and neck radiation fields. Exceptions can be made if determined by the PI\u002FCo-PI that the patient can proceed with protocol activities\n* Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue\n* Patients with simultaneous primary cancers outside of the oropharynx\n\n  o Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI\u002FCo-PI 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 to be 90% or greater\n\n  o Note: Exceptions can be made for patients with prior malignancies outside the oropharynx if determined by the PI\u002FCo-PI the patient can proceed with protocol activities.\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable\n* No particle therapy\n* Patients who are deemed non-compliant to all the protocol related activities\n* Contraindications to receive either cisplatin or the combination of carboplatin\u002F5-fluorouracil at the prescribed doses.\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",{"count":130,"type":20},291,[132],"PHASE3","The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following:\n\n* Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy\n* How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.",[37],[136,137,138,139,140,141,142],"oropharynx","tonsil","base of the tongue","oropharyngeal walls","radiation treatments","cisplatin","24-200","2026-06-02",{"date":145,"type":76},"2026-06-03",{"date":147,"type":76},"2024-08-19",{"date":149,"type":20},"2027-08",{"name":151,"class":83},"Memorial Sloan Kettering Cancer Center",9,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":160,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":121},"100589083","phase-2-cascade-2002-protect-study-probiotics-to-treat-anal-precancer-trial-100589083","NCT06949800","CASCADE 2002: PROTECT Study, \"PRObiotics to TrEat Anal preCancer Trial","Probiotics to Treat HSIL and Reduce Persistent High Risk HPV Infection in Women and Men Living With HIV","Inclusion Criteria:\n\n1. Signed informed consent\n2. Participant in ULACNet-101 or participant screened specifically for ULACNet-102.\n3. Biopsy-proven anal HSIL (men or women) shown as part of participation in the ULACNet-101 study or at a screening visit for ULACNet-102.\n4. At least one focus of anal HSIL must be large enough to be monitored for response, i.e.,not completely removed after the screening biopsy.\n5. Total volume of HSIL is less than 50% of the anal canal or perianal region.\n6. Must be actively on treatment with effective antiretroviral therapy (ART) regimen for at least three months preceding enrollment (Visit 1, Day 1) in ULACNet-101 or at screening for ULACNet-102.\n7. HIV RNA \\\u003C200 copies\u002Fml at baseline.\n8. Cluster of differentiation 4 (CD4) nadir above 200 cells per microliter (uL)\n9. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1 (Karnofsky \\>= 70%).\n10. Participants must meet the following laboratory parameters within 3 months before enrollment:\n\n    1. Leukocytes: ≥3,000\u002Fmm\\^3.\n    2. Absolute neutrophil count: ≥1,500\u002Fmm\\^3.\n    3. Platelets: ≥100,000\u002Fmm\\^3.\n    4. Elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin \\\u003C2 times the upper limit of normal.\n11. Not pregnant or breast feeding and one of the following:\n\n    1. Of non-childbearing potential (i.e. persons aged 60 years or older or who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses for at least 12 months and without an alternative medical cause).\n    2. Persons aged less than 60 years of childbearing potential and agree to practice highly effective contraception from initiation of taking EXE-346 or placebo through 14 days after taking the last dose of EXE-346 or placebo. Highly effective methods of contraception include one or more of the following:\n\n    i.Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant.\n\nii.Hormonal (oral, intravaginal, transdermal, implantable or injectable); Progestogen-only hormonal contraceptives without inhibition of ovulation are not considered to be highly effective.\n\niii. An intrauterine hormone-releasing system. iv. An intrauterine device. v. Bilateral tubal occlusion or removal. vi. Sexual abstinence, only if the participant refrains from heterosexual intercourse from initiation taking EXE-346 or placebo through 14 days after taking the last dose of EXE-346 or placebo and it is the usual lifestyle of the participant.\n\nExclusion Criteria:\n\n1. History of any anogenital cancer.\n2. Presence of untreated cervical HSIL or cervical cancer.\n3. Anal HSIL on clinical examination or biopsy that clinicians are concerned for cancer.\n4. Receipt of chemotherapy, radiotherapy or immunosuppressive medication in three months preceding enrollment in ULACNet-101 or at the screening visit for ULACNet-102.\n5. Immunosuppression as a result of underlying illness or treatment including:\n\n   1. Use of high dose corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) for \\>=7 days (inhaled, otic, topical and ophthalmic corticosteroids are permitted).\n   2. Primary immune deficiency disease.\n   3. Use of synthetic or biologic disease-modifying anti-rheumatic drugs.\n   4. History of bone marrow or solid organ transplant.\n   5. History of any other clinically significant autoimmune or immunosuppressive disease.\n6. Participant initiated a new treatment with antibiotics within the 2 weeks prior to screening or plans to start antibiotic therapy during the study period.\n7. Participant is taking NSAIDs as a long-term treatment (ie, consistent use for at least 4 days\u002Fweek each month). Acute use of NSAIDs is allowed.\n8. Participant has known hypersensitivity to EXE-346 or any product components.\n9. Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n10. Warts so extensive that they preclude the clinician from determining the extent and location of HSIL.\n11. Sustained, manually confirmed, sitting systolic blood pressure \\>150 mm Hg or \\\u003C90 mm Hg or a diastolic blood pressure \\>95 mm Hg as measured by 3 readings taken 15 minutes apart at screening or Visit 1.\n12. History of significant thrombocytopenia, history of thrombosis with thrombocytopenia (TTS) syndrome or heparin-induced thrombocytopenia.\n13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.\n14. Participant has participated in any clinical study of an approved or unapproved investigational medicinal product within the 30 days prior to screening.\n15. Any other finding that, in the opinion of the Investigator deems the participant unsuitable for the study","21 Years",{"count":162,"type":20},90,[23],"This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population",[166,37,167],"HSIL, High Grade Squamous Intraepithelial Lesion","Anal HSIL",[169,170,171],"HIV","Anal intraepithelial neoplasia (AIN) 3","p16+ AIN 2","NOT_YET_RECRUITING","2026-04-29",{"date":175,"type":76},"2026-05-01",{"date":177,"type":20},"2026-06-01",{"date":179,"type":20},"2027-05-31",{"name":181,"class":83},"University of California, San Francisco",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100438345","phase-2-trial-of-cemiplimab-or-cemip-chemo-followed-by-biomarker-guided-treatment-for-pts-whpv-hn-ca-100438345","NCT04988074","Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w\u002FHPV H&N Ca","A Phase II Trial of Cemiplimab, or Cemiplimab-Chemotherapy, Followed by Biomarker-guided De-escalated Curative-intent Locoregional Treatment for Patients With Advanced HPV-related Head and Neck Cancer. The MINIMA Study","MINIMA","Inclusion Criteria:\n\n* Subjects must have pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.\n* HPV testing must be compliant with the following criteria:\n\n  * p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al89).\n  * p16 IHC positivity is to be validated using an HPV nucleic acid based secondary assay (HPV ISH, HPV PCR, HPV cfDNA) before or during the neoadjuvant phase.\\*\n  * HPV DNA ISH is acceptable if positive, however a negative HPV DNA ISH should be confirmed by HPV RNA ISH or other nucleic acid based method.\n* HPV16 type (non-HPV16 related cancers are not eligible)\\*\n\n  * \\*In the rare event that a subject starts treatment based on p16 IHC alone and HPV type determination is not yet available, subject may commence neoadjuvant treatment based on p16 IHC alone, as along as HPV nucleic acid testing is pending. Patients with non-HPV16 associated tumors will have to leave the study. Given the prevalence of HPV16 (\\~90-95%) and usual rapid turnaround of HPV16 RNA-ISH (other assays) this is not expected, but the primary goal is not to have unnecessary treatment delay for subjects.\n* Availability of ≥8 unstained 5 micron slides. Subjects who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study. In patients where biopsy is not safe, or logistically feasible this requirement can be waived by the PI or a lower number of slides can be accepted.\n* Subjects must be at least 18 years of age.\n* AJCC 7th edition: Stage III, IV without bulky N2b\u002Fc disease (defined as N3 equivalent volume) and without bulky T4 (≤30cc).\n\n(AJCC 8th edition: Stage II or III, or stage I with N1 or N2 nodes (\\>3cm or multiple), without bulky nodal disease (defined as N3 equivalent volume) and without bulky T4 disease (defined as 30cc tumor volume)).\n\n* Measurable disease (either primary site and\u002For nodal disease) by RECIST 1.1 criteria.\n* No previous radiation or chemotherapy for a head and neck cancer.\n* No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy\u002Fexcision of the tumor with residual disease is acceptable).\n* ECOG performance status 0-1 (Karnofsky ³70%).\n* Normal Organ Function\n\n  * Leukocytes ≥2500\u002Fmm3,\n  * Platelets ≥75,000\u002Fmm3,\n  * Absolute neutrophil count ≥1,500,\n  * Hemoglobin \\>9.0 gm\u002FdL,\n  * AST and ALT \\\u003C2.5 X ULN\n  * Alkaline phosphatase \\\u003C2.5 X ULN\n  * Albumin \\>2.9 gm\u002FdL,\n  * Total bilirubin ≤1.5 mg\u002Fdl,\n  * Creatinine clearance \\>45 mL\u002Fmin (or SCr \\\u003C1.6 mg\u002FdL) within 4 weeks prior to start of treatment.\n\n    * The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate CrCl for enrollment or dosing\n* Subjects must sign a study-specific informed consent form prior to study entry. Subjects should have the ability to understand and the willingness to sign a written informed consent document.\n* Sex, and Reproductive Status:\n\n  * Women of childbearing potential (WOCBP=premenopausal woman capable of becoming pregnant) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug.\n  * Women must not be breastfeeding.\n  * WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for up to 5 months post-treatment completion.\n  * Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for up to 7 months post treatment completion.\n  * Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.\n\nExclusion Criteria:\n\n* Unequivocal demonstration of distant metastases (M1 disease).\n* Unidentifiable\u002Funknown primary site (neither imaging nor exam nor biopsy can identify the primary). Treating physicians should agree that the primary is sufficiently identified to proceed with clinical care\u002Ftreatment (e.g. in the case of imaging localization, but absence of biopsy proven pathology)\n* Intercurrent medical illnesses which would impair subject tolerance to therapy or limit survival. Including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance. Once clinically stable, as defined by the PI, they are eligible.\n* Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns (please see above paragraph under inclusion criteria regarding WOCBP)\n* Prior surgical therapy other than incisional\u002Fexcisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment on study as outlined above\n* Subjects receiving other investigational agents.\n* Peripheral neuropathy \\>grade 1\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has a known history of active tuberculosis (Bacillus Tuberculosis infection)\n* Has hypersensitivity to cemiplimab or any other drug used in this protocol.\n* Has had a prior systemic anti-cancer treatment within the last 8 weeks\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 or thyroid cancers, any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment other than hormonal therapies (e.g., adjuvant after breast cancer, or low grade prostate cancer).\n* Has active autoimmune disease that has required systemic treatment in the past year (i.e., with use of steroids or immunosuppressive drugs). Replacement therapy e.g., levothyroxine, insulin, or physiologic corticosteroid doses for adrenal or pituitary insufficiency, etc. are not considered a form of systemic treatment.\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has a history of Human Immunodeficiency Virus (HIV) (HIV ½ antibodies).\n* Has known active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). However, if eradicated subject is eligible.\n* Has received a live vaccine within 28 days of planned start of study therapy.\n\n  * Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 28 days prior to initiation of treatment.",{"count":191,"type":20},32,[23],"To determine if it is feasible to use neoadjuvant immunotherapy (or immunotherapy plus chemotherapy) to reduce treatment intensity and improve long-term quality of life while maintaining very high cure rates.",[37],"2026-02-27",{"date":197,"type":76},"2026-03-03",{"date":199,"type":76},"2021-12-13",{"date":201,"type":20},"2027-12",{"name":203,"class":83},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",1,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":211,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":227,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":121},"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":213,"type":20},145,[23],"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)",[217,39,218,37,219,220,221,222,223,224,225,226],"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",[217,39,226,225,224,223,222,221,220,219],"2025-07-28",{"date":230,"type":76},"2025-07-30",{"date":232,"type":76},"2021-07-02",{"date":234,"type":20},"2032-06-01",{"name":236,"class":83},"Jonathan Schoenfeld, MD, MPH",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":252,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":4},"100554935","phase-1-phase-12-study-of-autologous-scg142-tcr-t-cells-in-patients-with-hpv1652-positive-carcinoma-100554935","NCT06505551","Phase 1\u002F2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16\u002F52-positive Carcinoma","A Phase 1\u002F2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas","Main Inclusion Criteria:\n\n1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.\n2. Tumor tissue positive for HPV16 or HPV52.\n3. Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and\u002For combination chemo-immunotherapy.\n4. Human leukocyte antigen (HLA)-A\\*02:01 genotype.\n5. Measurable disease as defined by RECIST v1.1.\n6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.\n7. Anticipated life expectancy ≥3 months.\n8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.\n\nMain Exclusion Criteria:\n\n1. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.\n2. Active brain metastasis or leptomeningeal metastases.\n3. History of other malignancy within 2 years prior to Screening.\n4. History of organ transplant.\n5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n6. History of active cardiac disease.\n7. History of active pulmonary disease.\n8. Active, known, or suspected autoimmune disease.\n9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.\n10. Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR\u002FTCR-T cell therapy.\n11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and\u002For any component of SCG142.\n12. Any serious medical condition or abnormality in clinical laboratory tests.",{"count":245,"type":20},66,[95,23],"This is a phase 1\u002F2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and\u002For combination chemo-immunotherapy",[37,249,45,44,250,43,251],"HPV-Related Cervical Squamous Cell Carcinoma","HPV-Related Vaginal Squamous Cell Carcinoma","HPV-Related Head and Neck Cancer",[253,57,26,254,255,99,31,32,29,256,257,101,258],"Human Papilloma Virus","Head and Neck Cancer","Oropharyngeal Cancer","Anogenital Cancer","TCR T Cell","T cell receptor T cell","2024-07-10",{"date":261,"type":76},"2024-07-17",{"date":263,"type":20},"2024-10",{"date":265,"type":20},"2028-12",{"name":267,"class":268},"SCG Cell Therapy Pte. Ltd.","INDUSTRY",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":279,"conditions":280,"keywords":288,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100484019","phase-1-autologous-t-cells-targeting-hpv16-hpv18--survivin-in-patients-with-rr-hpv-related-oropharyngeal-cancers-100484019","NCT05582590","Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R\u002FR HPV-related Oropharyngeal Cancers","A Phase 1 Open-Label Dose-Escalation Study of the Safety of Adoptively Transferred Autologous CD8+ T Lymphocytes Targeting HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 and Survivin in Patients With Relapsed or Refractory HPV-related Oropharyngeal Cancers","Inclusion Criteria:\n\n1. The patient will be typed for HLA-A\\*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor.\n2. Patients with cytologically or histologically confirmed locally advanced or metastatic HPV related oropharyngeal cancers with confirmed detection of HPV-16 and\u002For HPV-18.\n3. Patients with HPV-related oropharyngeal cancers who have received at least 1 prior line of standard-of-care (SOC) treatment (for example, per the current NCCN Guidelines for Patients with Oropharyngeal Cancer) consisting of systemic immunotherapy and\u002For chemotherapeutic treatment.\n\n   1. The last dose of cytotoxic chemotherapy and\u002For steroids must be administered at least 28 days prior to the leukapheresis procedure.\n   2. Any adverse event(s) that the patient may have experienced from prior therapy must have resolved to ≤ Grade 1 according to NCI CTCAE version 5.0.\n4. Measurable disease per RECIST v1.1 criteria (at least 1 lesion that can be measured accurately in at least 1 dimension with the longest diameter ≥ 10 mm \\[MRI or CT scan sliced thickness ≤ 5 mm\\]).\n5. Pulse oximetry ≥ 92% on room air.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Life expectancy of at least 3 months.\n8. Be willing to comply with the study schedule and all other protocol requirements.\n9. Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have 2 negative pregnancy tests prior to treatment. All sexually active WOCBP and all sexually active male patients must agree to use highly effective methods of birth control throughout the study.\n10. Ability of the patient to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment. Patients taking adjuvant hormonal therapy for definitively treated cancers (e.g., breast cancer, prostate cancer) are eligible.\n2. Major surgery within 28 days prior to the first study drug administration (minimally invasive procedures, such as diagnostic biopsies, are permitted).\n3. Known central nervous system involvement.\n4. Treatment with an allogeneic hematopoietic stem cell transplantation.\n5. Treatment with any investigational agent(s) at the time of informed consent.\n6. Left ventricular ejection fraction (LVEF) \\\u003C 45%, congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.\n7. The following hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support):\n\n   1. Hemoglobin \\\u003C 9.0 g\u002FdL.\n   2. Platelet count \\\u003C 100,000\u002FμL.\n   3. Absolute neutrophil count (ANC) \\\u003C 1000\u002F μL.\n8. The following chemistry laboratory results at Screening:\n\n   1. Serum creatinine ≥ 1.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) ≤ 50 mL\u002Fmin\u002F1.73 m\\^2.\n   2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3x the upper limit of normal (ULN) or serum total bilirubin \\> 2 mg\u002FdL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome).\n9. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\> 1.5x ULN within 1 week prior to the start of lymphodepletion chemotherapy, unless on a stable dose of an anticoagulant.\n10. Are pregnant or breastfeeding.\n11. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment.\n\n    1. Inactivated annual influenza vaccination is allowed.\n    2. Vaccines such as COVID-19 vaccine, e.g., SARS-CoV-2 vaccine \\> 7 days before administration is acceptable. For vaccines requiring more than 1 dose, the full regimen should be completed prior to Cycle 1 Day 1.\n12. Active bacterial, viral, or fungal infection within 72 hours of the start of lymphodepletion chemotherapy; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection.\n13. Have human immunodeficiency virus (HIV) active infection as indicated by positive HIV polymerase chain reaction (PCR) test, human T-cell leukemia virus type 1 infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being hepatitis B surface antigen \\[HbsAg\\] positive, or anti-HBe-antibody positive), or are positive for HBV DNA. HCV ribonucleic acid (RNA) must be undetectable by laboratory test.\n14. Any condition including the presence of laboratory abnormalities, that places the patient at an unacceptable risk if the patient was to participate in the study.\n15. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n    Note: 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 permitted.\n16. Patients who experienced the following immune checkpoint inhibitor-related AEs even if the AE resolved to ≤ Grade 1 or baseline:\n\n    1. ≥ Grade 3 ocular AE\n    2. Changes in liver function tests that met the criteria for Hy's Law (\\> 3× ULN of either ALT\u002FAST with concurrent \\> 2× ULN of total bilirubin (total and direct) and without alternate etiology)\n    3. ≥ Grade 3 neurologic toxicity\n    4. ≥ Grade 3 colitis\n    5. ≥ Grade 3 renal toxicity",{"count":277,"type":20},36,[95],"This is a multicenter, open-label, Phase I, first-in-human trial to characterize the safety and clinical activity of an antigen-specific CD8+ T-cell product in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers. Patients must have received at least one prior standard treatment regimen consisting of systemic immunotherapy and\u002For chemotherapy. The investigative agent is an autologous adoptive T-cell product derived from the patient's endogenous cytolytic T cells that are directed toward HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 antigens, and a tumor-associated antigen (Survivin) by ex vivo exposure to an artificial antigen presenting cell to which HLA-A2 antigen-peptides have been fit within the pocket of an MHC class 1 molecule. Patients must express HLA-A\\*0201.",[255,253,254,281,282,283,284,37,285,286,287],"Head and Neck Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Cancer, Metastatic","Head and Neck Cancer Metastatic","HPV-Related Mucosal Head and Neck Squamous Cell Carcinoma","Relapsed Oropharyngeal SCC","Refractory Oropharyngeal Squamous Cell Carcinoma",[289,290,291,292,63,53,293,294],"relapsed or refractory HPV-related oropharyngeal cancer","human papilloma virus-related cancer","HPV-related head and neck cancer","HPV-related oropharyngeal cancer","NEXI-003","Head and neck cancer","2024-01-12",{"date":297,"type":76},"2024-01-16",{"date":299,"type":20},"2025-03-31",{"date":301,"type":20},"2027-08-25",{"name":303,"class":268},"NexImmune Inc."]