[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hpv-related-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hpv-related-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,112,147,177,204,228,252,279,309,334],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100625624","phase-2-cthpvdna-response-adapted-chemoradiation---retifanlimab-treatment-in-locally-advanced-anal-cancer-100625624",false,"NCT07425054","ctHPVDNA Response-Adapted Chemoradiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer","ctHPVDNA Adapted ChemoRadiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC)","CHART-AC","Inclusion Criteria:\n\n* Participants must have histologically proven stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Special considerations include the following:\n\n  * Participants with excision of the primary tumor but with node positive disease or residual disease at the primary if T3-T4N0 will be eligible.\n* Age ≥18 years\n* ECOG performance status 0-2\n* Creatinine clearance \\>30 ml\u002Fmin by Cockcroft-Gault Equation.\n* HIV-infected participants are eligible if they meet the following eligibility criteria:\n\n  * A CD4 T-cell count \\>= 200\u002Fmm3 and a viral load \\\u003C 200 copies\u002Fmm3\n  * No history of AIDS-related complications within past year other than history of low CD4+ T-cell count (\\>200\u002Fmm3) prior to initiation of combination antiretroviral therapy.\n  * Participant must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer.\n  * Participant MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants will be eligible regardless of antiretroviral medication provided the regimen has been stable for at least 4 weeks.\n  * Participants must be PPD negative. Alternatively, the QuantiFERON-TB assay can be used. An individual is considered positive for M. tuberculosis infection if the IFN-γ response to TB antigens is above the test cut-off (after subtracting the background IFN-γ response in the negative control). The result must be obtained within 20 weeks prior to enrollment. PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment.\n* Tumor size must be documented based on physical examination including digital rectal exam and\u002For anoscopy\u002Fproctoscopy within 4 weeks prior to enrollment.\n* Staging imaging studies must include a PET scan AND either a CT with contrast of the abdomen\u002Fpelvis or an MRI with contrast of the pelvis. It is preferred that participants receive contrast. For participants with an allergy who cannot receive pre-medication, or any other reason they can't receive IV contrast, it is recommended that they undergo an MRI of the pelvis.\n* Participant must have no history of prior chemotherapy for anal cancer.\n* Participant must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus. However, participants who undergo local excision or excisional biopsy are eligible provided there was tumor involvement of the anal canal and\u002For anal verge prior to the resection, if the margins were positive, and\u002For if the stage is T2N0 based on tumor size before the procedure. This means that participants with T1N0M0 anal margin squamous cell carcinoma who underwent surgical excision with negative margins and no involvement of the anal verge and\u002For anal canal are not eligible.\n* Participant must not be receiving any other standard anti-cancer therapy or experimental agent.\n* Participant must not have intercurrent illness including, but not limited to, ongoing or active infection or psychiatric\u002Fsocial situations that, in the judgement of the investigator, would limit compliance with study requirements.\n* Participant must not have had significant cardiovascular disease within 6 months prior to enrollment that has not been treated\u002Fcontrolled in the opinion of the treating investigators including myocardial infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary artery disease, symptomatic congestive heart failure, or uncontrolled cardiac arrhythmia.\n* Participant must not have a history of a different malignancy unless they are deemed by the investigator to be at low risk of recurrence.\n* Participants who are on anti-coagulation with warfarin within 2 weeks prior to enrollment must use an alternative anti-coagulant if planned to receive Capecitabine, otherwise, they must receive infusional 5-FU.\n\n  * NOTE: Low molecular weight heparin is permitted provided the participant's PT\u002FINR is \\\u003C 1.5. Participants who will received capecitabine and are on Dilantin for a seizure disorder must have Dilantin levels checked weekly.\n* Participants must have normal organ and marrow function as defined below:\n\n  * Hemoglobin ≥ 10.0 g\u002Fdl\n  * Platelet count ≥ 100,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Total bilirubin must be \\\u003C1.5 X institutional ULN OR conjugated bilirubin \\\u003C= institutional ULN if total bilirubin \\> 1.5 X ULN. Note that conjugated bilirubin only needs to be tested if total bilirubin \\>1.5 X ULN. Participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician.\n  * AST\u002FALT must be \\\u003C\u002F= 2.5 X institutional ULN (participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician).\n  * Albumin \\>\u002F= 3.0 g\u002FdL\n* Women must not be pregnant or breast-feeding because the study treatment may cause harm to an unborn fetus or breastfeeding child. A female of childbearing potential is defined as any woman, regardless of sexual orientation, or whether they have undergone a tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for at least six months after the completion of treatment.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants must have testing DPYD deficiency per institutional standards and must not be homozygous for DPYD deficiency.\n\nExclusion Criteria:\n\n* Any prior pelvic radiation or previous radiation that would result in overlapping radiation fields.\n* History of allergic reactions to compounds similar to capecitabine,\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.\n* Participants with inflammatory bowel disease, scleroderma, or known homozygosity for DPYD deficiency.\n* Participants with a fistula between the tumor and invaded organ\n* Participant must not have active autoimmune disease or inflammatory bowel disease that has required systemic treatment in past 2 years\n* No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)\n* No participants with immunodeficiency or receiving systemic steroid therapy equivalent to \\> 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. Topical corticosteroid or occasional inhaled corticosteroids are allowed.\n* No live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.\n* Participants must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to retifanlimab.\n* Participants are excluded if known to be homozygous for Dihydropyrimidine Dehydronase","ALL","18 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is for people who have anal cancer and have not yet had treatment. The regular treatment for people who have anal cancer is chemoradiation therapy (CRT). CRT is when chemotherapy and radiation therapy are given at the same time. Studies show that CRT works well to treat anal cancer and prevents many people from needing surgery which may require a colostomy bag. Doctors know that CRT is an effective way to treat anal cancer. But, they are doing studies to find out how much dose of radiation and chemotherapy should be given during the CRT. Higher doses of chemotherapy and radiation could increase the risk of side effects, but lowering the dose of chemoradiation has the risk of not being as effective to treat the cancer. One way to predict whether participants need higher or lower doses of radiation therapy is to do a blood test called ctDNA (circulating tumor DNA) to test for the presence of human papillomavirus (HPV). This test is done at certain times while participants are getting CRT. This has been shown to be a marker for the presence of anal cancer.\n\nIn this study, doctors will tailor lower versus higher doses of CRT based on the tumor response that is measured by ctDNA. The purpose of this study is to see if customizing the dose of chemoradiation based on the amount of ctDNA will increase survival in participants with anal cancer and\u002For decrease the risk of side effects. Some participants in this study whose cancer does not respond as well to the CRT may have the opportunity to receive a drug called Retifanlimab that stimulates the body's immune system. Retifanlimab is approved by the Federal Drug Administration (FDA) for treating anal cancer that is recurrent or metastatic since there is proven benefit in these situations.",[27,28,29],"Anal Cancer","HPV-Related Carcinoma","Squamous Cell Carcinoma of the Anus",[31,32],"Chemoradiation","Retifanlimab","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":21},"2026-06-19",{"date":41,"type":21},"2029-01",{"name":43,"class":44},"Jennifer Dorth","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":77,"overallStatus":33,"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":54,"type":21},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.",[58,59,60,27,61,62,63,64,65,28,66,67,68,69,70,71,72,73,74,75,76],"Cervical Cancer","Throat Cancer","Oropharynx Cancer","Vulva Cancer","Vaginal Cancer","Penile Cancer","Metastatic Cancer","HPV-Related Malignancy","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",[78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101],"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","2026-06-10",{"date":104,"type":37},"2026-06-12",{"date":106,"type":37},"2023-03-07",{"date":108,"type":21},"2027-01-01",{"name":110,"class":44},"Christian Hinrichs",3,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":45},"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":21},15,[122,24],"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.",[125,28,65,69,68,71,67,73,74,75,72,58,60,27,126,63,62],"HPV-Associated Cervical Carcinoma","Vulvar Cancer",[87,128,129,130,131,31,132,79,90,82,133,134,135,136,137,138,139,140],"Cell therapy","Adoptive cell therapy","Immunotherapy","Radiation","CAR-T, cell therapy","Gene therapy","Cervical cancer","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy",{"date":104,"type":37},{"date":143,"type":37},"2025-08-11",{"date":145,"type":21},"2026-10-01",{"name":110,"class":44},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":111},"100528160","phase-2-prgn-2009-in-combination-with-pembrolizumab-in-patients-with-recurrent-or-metastatic-cervical-cancer-100528160","NCT06157151","PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer","A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.","Inclusion Criteria:\n\n* Age 18 years and older.\n* Recurrent or metastatic cervical cancer (histologically or cytologically confirmed)\n* Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks.\n* Subjects must have histologically or cytologically confirmed HPV positive disease\n* Measurable disease that can be accurately measured by RECIST v1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks from the time of enrollment.\n* Must have adequate organ function\n* Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.\n* All patients must have the ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs.\n* Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control.\n* Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment.\n* History of non-infectious pneumonitis or interstitial lung disease.\n* History of endocrine autoimmune disease (exceptions: treated Graves' disease; hypothyroidism on replacement).\n* Live vaccine within 30 days prior to first dose.\n* Patients with presence of other active malignancy within 1 year prior to study entry\n* Known Central Nervous System (CNS) disease\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Known history of active tuberculosis (TB, Bacillus tuberculosis).\n* Pregnant and lactating women are excluded from this study.\n* Patients with a history of solid organ transplant.\n* Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.\n* Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.",{"count":155,"type":21},24,[24],"This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.",[58,28,65,159,160],"Recurrent Cervical Carcinoma","Metastatic Cervical Cancer",[162,58,163,164,165,166],"Human Papilloma Virus","Pembrolizumab","Therapeutic Vaccine","Cervix Cancer","Resistance to Checkpoint Inhibitors","2026-04-20",{"date":169,"type":37},"2026-04-23",{"date":171,"type":37},"2025-11-11",{"date":173,"type":21},"2030-11-30",{"name":175,"class":176},"Precigen, Inc","INDUSTRY",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"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":185,"type":21},30,[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.",[87,60,28,65,69],[190,191,192,193,194],"ctDNA","NavDx test","21-434","HPV-OPC","Memorial Sloan Kettering Cancer Center","2026-04-10",{"date":197,"type":37},"2026-04-13",{"date":199,"type":37},"2022-03-24",{"date":201,"type":21},"2027-03-24",{"name":194,"class":44},8,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":45},"100428322","detecting-hpv-dna-in-anal-and-cervical-cancers-100428322","NCT04857528","Detecting HPV DNA in Anal and Cervical Cancers","Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy","Inclusion Criteria:\n\n* Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.\n* Age ≥ 18 years\n* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy\n\nExclusion Criteria:\n\n* Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the\n* Planned to undergo radiation therapy as an adjuvant or post-operative therapy",{"count":54,"type":21},"OBSERVATIONAL","This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.",[58,27,73,66,28,215],"Uterine Cervical Cancer",[87,217,94,96,218],"radiation treatment","uterine cervix","2026-03-02",{"date":221,"type":37},"2026-03-04",{"date":223,"type":37},"2020-10-06",{"date":225,"type":21},"2027-11-15",{"name":227,"class":44},"University of Chicago",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":235,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":250,"locationsCount":45},"100539579","biomarker-approach-to-screening-for-the-early-detection-of-hpv-related-oropharyngeal-cancer-bash-opc-100539579","NCT06305676","Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)","BASH OPC","Inclusion Criteria:\n\nCases:\n\n* Aged at least 18 years\n* Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)\n* Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks\n* Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker\u002Fbiobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center\n* Aged at least 35 years\n* Have no previous diagnosis of HNC or HPV-related cancer\n* Fully understands study procedures\n* Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker\u002Fbiobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center\n\nExclusion Criteria:\n\n* Not meeting all of the above inclusion criteria for either the case or control group",true,{"count":237,"type":21},400,"Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race\u002Fethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).",[240,28],"Oropharyngeal Cancer",[240,242,243],"Early Detection","Screening","2026-02-05",{"date":246,"type":37},"2026-02-09",{"date":248,"type":37},"2024-01-22",{"date":41,"type":21},{"name":251,"class":44},"H. Lee Moffitt Cancer Center and Research Institute",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":235,"sex":259,"minAge":18,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":203},"100459391","phase-3-a-phase-iii-clinical-trial-of-a-11-valent-recombinant-human-papillomavirus-vaccine-hansenulapolymorpha-in-chinese-women-aged-9-45-years-100459391","NCT05262010","A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years","A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years","Inclusion Criteria:\n\n\\- non-gynecological related\n\n1. \\*Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;\n2. \\*Axillary body temperature \\\u003C37.3℃ on the day of enrollment;\n3. The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;\n4. Subjects have the ability to read, understand, and fill out research application forms such as diary cards\u002Fcontact cards, and promise to follow the research requirements participate in follow-up visits;\n5. No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;\n6. The subject has a negative urine pregnancy test on the day before vaccination.\n\n   \\- Gynecology related\n7. \\*Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.\n8. \\*Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed\u002Fwashed vagina (Except for normal bathing outside the vagina）, no vaginal drugs or preparations are used.\n\nExclusion Criteria:\n\nFirst dose exclusion criteria:\n\n(Visits may be rescheduled if the criteria described in the \"\\*\" option are met at screening)\n\n\\- Non-gynecological related\n\n1. \\* Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and\u002For diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;\n2. \\*3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;\n3. \\*Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;\n4. \\*3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);\n5. History of severe allergies\u002Fconditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);\n6. Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;\n7. 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg\u002Fkg\u002Fday or ≥20 mg\u002Fday prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;\n8. Previous splenectomy or impaired spleen function;\n9. Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;\n10. Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;\n11. Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;\n12. Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;\n13. The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).\n\n    \\- Gynecology related\n14. \\*Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;\n15. \\*The subject is in the menstrual period;\n16. \\*Acute lower genital tract infection (such as acute vulvitis\u002Fvaginitis\u002Fcervicitis, etc.) found by the naked eye during gynecological examination;\n17. Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.);\n18. Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);\n19. Previous hysterectomy or pelvic radiation therapy or severe cervical\u002Fvaginal dysplasia.\n\nExclusion criteria for 2nd and 3rd dose vaccination：\n\nIf any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.\n\n* Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;\n* Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.","FEMALE","45 Years",{"count":262,"type":21},13500,[264],"PHASE3","A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.",[267,28],"HPV InfectioN",[269],"HPV Infection HPV vaccine","2026-01-15",{"date":272,"type":37},"2026-01-16",{"date":274,"type":37},"2022-06-04",{"date":276,"type":21},"2028-06",{"name":278,"class":176},"National Vaccine and Serum Institute, China",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":308},"100565292","phase-2-dynamic-ctdna-assessment-in-cervical-and-anal-canal-tumors-optimizing-follow-up-and-clinical-outcomes-100565292","NCT06640283","Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes","Dynamic Assessment of ctDNA in Patients With Cervical and Anal Canal Tumors to Optimize Follow-up and Clinical Outcomes in the Brazilian Unified Health System (SUS)","ANA","Inclusion Criteria:\n\n1. Histological diagnosis of anal canal or cervical cancer.\n2. Documented presence of HPV.\n3. Locally confined or locally advanced disease, defined as:\n\n   1. Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition;\n   2. Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition.\n4. Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy.\n5. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1.\n6. Age ≥ 18 years.\n7. Signing of the Informed Consent Form (ICF).\n8. HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200.\n9. Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer.\n\nExclusion Criteria:\n\n1. Patients with unequivocal distant metastasis at diagnosis.\n2. For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal radiological progression in the first imaging exam after the completion of radiotherapy (with or without chemotherapy) or routine indication for salvage surgery immediately after the conclusion of definitive treatment.\n3. Need for recurrent blood transfusions, such as weekly frequency.\n4. Another uncontrolled disease representing a life risk, as determined by medical judgment.\n5. Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas.\n6. Pregnant individuals.\n7. Active opportunistic infection or disease.\n8. History of autoimmune diseases.",{"count":288,"type":21},150,[24],"After definitive radiotherapy (RT) treatment (with or without chemotherapy), cervical and anal canal neoplasms frequently exhibit disease persistence or recurrence. Due to the local inflammatory process post-treatment, response assessment by imaging (current gold standard) is limited, often necessitating multiple follow-ups and repeated invasive biopsies. Conventional follow-up is complex and costly, requiring equipment from secondary and tertiary services, trained radiologists, and patient exposure to radiation and contrast.\n\nIn this context of human papillomavirus(HPV)-related neoplasms, recent studies have demonstrated the role of ctDNA (circulating tumor DNA) in assessing the risk of recurrence or disease progression, providing a rationale for using the tool in two fronts:\n\n* Optimizing follow-up based on serial monitoring of ctDNA;\n* Selecting patients with positive ctDNA after RT, who are at high risk of recurrence, for treatment intensification.\n\nMonitoring with ctDNA as a standalone follow-up tool in cases evolving with negative ctDNA after RT has the potential to replace imaging exams, being a minimally invasive test performed on a peripheral blood sample. Currently, ctDNA testing has expensive methodologies not available in the Unified Health System (SUS). This project aims to develop a methodology for ctDNA evaluation focused on HPV ctDNA research that is low-cost and executable in SUS, as well to assess the accuracy of this test in the population with HPV-related tumors.\n\nAdditionally, we will evaluate whether the early introduction of immunotherapy in patients with positive ctDNA after definitive treatment can increase cure rates. Immunotherapy already has a well-defined role in the treatment of metastatic HPV-related neoplasms. Recently, the use of anti-programmed death-1 (anti-PD1) has also shown benefits in patients with locally advanced cervical cancer with a high risk of recurrence who are candidates for chemoradiotherapy (CRT). Therefore, its use focused on HPV-related tumors, as well as a better understanding of which patients benefit from this strategy, warrants further investigation.",[28,215,292,73,66],"Anal Canal Cancer",[87,190,294,295,296,297,298],"Cervical tumors","Anal canal tumors","Molecular diagnosis","Diagnostic test","Biomarkers","2025-12-18",{"date":301,"type":37},"2025-12-24",{"date":303,"type":37},"2025-03-14",{"date":305,"type":21},"2027-01",{"name":307,"class":44},"Instituto do Cancer do Estado de São Paulo",1,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":235,"sex":17,"minAge":316,"maxAge":260,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":308},"100574206","phase-2-to-evaluate-the-safety-and-immunogenicity-of-15-valent-hpv-recombinant-vaccine-in-chinese-people-aged-9-45-years-100574206","NCT06756269","To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years","A Randomised, Double-blind, Placebo and Positive Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 9-45 Years","Inclusion Criteria:\n\n1. Participants aged 9-45；\n2. Participants aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；\n3. Participants and\u002For their guardian sign an informed consent form;\n4. Axillary temperature less than 37.3 ℃（\\>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；\n5. Be able to comply with study protocol requirements；\n6. Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study, and were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period, and had no birth plan within the 30 days after receiving the whole vaccination;\n7. Agree to take effective contraceptive measures within 30 days after receiving the whole vaccination (effective contraceptives include: oral contraceptives, injection or embedding contraceptives, sustained release topical contraceptives, hormone patches, intrauterine devices), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.\n\nExclusion Criteria:\n\n1. Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；\n2. Plan to participate other clinical trials during the study period，or participated other clinical trials （including vaccine or drug）and received medication or vaccine within 3 months before enrollment ,\n3. History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;\n4. History of CIN2\u002FAIS\u002FCervical Cancer\u002FPelvic radiation therapy in female participants;\n5. History of HPV-related external genital diseases (such as genital warts, Vulvar intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Penis\u002Fperianal\u002Fperineum intraepithelial neoplasia, Penile\u002Fperianal\u002Fperineal cancer) 、anal intraepithelial neoplasia and related cancer, or head and neck cancer；history of sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydia infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma, inguinal granuloma, etc.);\n6. Has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection\u002FAIDS, SCID; Or Autoimmune Diseases (such as systemic lupus erythematosu, Rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis, Type 1 diabetes, Graves' disease, hashimoto thyroiditi, etc.);\n7. History of convulsions, epilepsy, except of febrile convulsions in children 5 years of age and younger;\n8. History of severe allergy that requires medical intervention, including but not limited to severe adverse reactions caused by vaccine or drug, eg anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia sexual purpura, local allergic necrosis (Arthus reaction), widespread urticaria, dyspnea, angioedema, etc.; History of severe side effect caused by vaccination or severe allergy to any of the components of the investigational vaccine, including histidine, sodium chloride, aluminium phosphate, Polysorbate 80 and water for injection;\n9. Severe diseases, as determined by the investigator, that affect vaccination eligibility, whether past or current, include severe cardiovascular disease, severe liver and kidney disease, malignant tumor, and serious infectious disease, such as: tuberculosis, viral hepatitis, etc.;\n10. Before the enrollment, the physical examination was untreatment or uncontrolled hypertension, (18-45 year old: systolic blood pressure ≥140mmHg and \u002F or diastolic blood pressure ≥90mmHg, 9-17 year old: systolic blood pressure ≥120mmHg and \u002F or diastolic blood pressure ≥80mmHg);\n11. Coagulation disorders: such as Congenital or acquired hemophilia, Coagulation factor deficiency, clotting disorders, thrombocytopenia, etc.;\n12. No spleen or functional spleen, and no spleen caused by any condition;\n13. Receive any Immunosuppressive therapy product within 1 month prior to the first vaccination, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination)，e.g. systemic medication for glucocorticoid (\\>20mg\u002Fday or 2mg\u002Fkg\u002Fday, continuous use ≥2 weeks), but local medication can be used (such as ointment, eye drops, inhalants) Or nasal spray);\n14. Receive any immunoglobulin or blood product within 3 months prior to the first injection, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination);\n15. 3 days before vaccination, suffering from acute illness or acute exacerbation of chronic disease; using fever reducer, Antihistamines, and Analgesics(such as: Acetaminophen, Ibuprofen, loratadine, Cetirizine, etc. )\n16. Receiving inactivated vaccine or recombinant vaccine or live-attenuated vaccine or nucleic acid vaccine or adenovirus vaccine within 14 days before vaccination;\n17. History of mental disorders or family history of mental health disorder (immediate family);\n18. Plan to move out of the city before the end of the study or leave the local area for a long time during the scheduled study visit;\n19. The investigator believes that the participant has any condition that may interfere with the assessment of the purpose of the study.","9 Years",{"count":318,"type":21},330,[24],"To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.",[322,28,323,324],"HPV Infection","HPV-Related Intraepithelial Neoplasia","Genital Wart","2025-12-16",{"date":327,"type":37},"2025-12-17",{"date":329,"type":37},"2025-01-15",{"date":331,"type":21},"2026-01-13",{"name":333,"class":176},"Shanghai Bovax Biotechnology Co., Ltd.",{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":235,"sex":259,"minAge":4,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":354,"locationsCount":308},"100560203","determining-the-frequency-of-occurrence-and-defining-the-most-appropriate-screening-test-for-anal-intraepithelial-neoplasia-ain-in-patients-with-human-papillomavirus-hpv-related-gynecological-diseases-100560203","NCT06574087","Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.","Inclusion Criteria:\n\n* HPV related gynecological disease confirmed in histo-pathological examination\n* the posibility to obtain material from gynecological organ and from anal canal",{"count":341,"type":21},248,[343],"NA","The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD survivors and additionally to establish an exact risk for each of HPV-related gynecological precancers\u002Fcancers. Moreover, the most appropriate screening test for HSIL(AIN) in this group of patients will be determined. It will be effectuated by performing two kinds of tests: hrHPV test for the 14 most common oncogenic HPV types and the liquid cytology from both the lower genital tract and anal canal with subsequent high resolution anoscopy (HRA) with potential biopsy\u002Fexcision of suspected lesions and histopathological examination.",[28,322],[96,87,347],"anal intraepithelial neoplasia","2025-07-18",{"date":350,"type":37},"2025-07-23",{"date":352,"type":37},"2023-01-13",{"date":305,"type":21},{"name":355,"class":44},"PCK Marine Hospital in Gdynia"]