{"entity":{"id":"nct03260023","kind":"trial","name":"Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers","aka":[],"tldr":"A phase 1/2 trial of Avelumab in penile cancer, run by Transgene, active and no longer recruiting.","summary":"Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers is a phase 1/2 interventional study registered as NCT03260023 by Transgene, with 143 participants enrolled, started 2017-09-01 and due to reach its primary completion in 2024-09-18. Interventions recorded: TG4001, Avelumab. Conditions listed: HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03260023","url":"https://clinicaltrials.gov/study/NCT03260023"}],"tags":["ctgov-ingest"],"related":[],"cancers":["penile","node-positive-penile-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":["transgene"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03260023","phase":"1/2","setting":"A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.","sponsor":"Transgene","started":"2017-09-01","startedType":"actual","yearReported":2025,"enrolled":143,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1, Overall Response Rate","primary":true,"unit":"%","arms":[{"name":"Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab","n":30,"value":16.67,"note":"95% CI 5.64 to 34.72; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03260023?tab=results"},{"endpoint":"Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1","primary":true,"unit":"months","arms":[{"name":"Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab","n":46,"value":3,"note":"90% CI 2.0 to 4.4; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication"},{"name":"Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab","n":44,"value":2.8,"note":"90% CI 1.7 to 4.2"}],"hr":0.87,"p":"0.2810","source":"https://clinicaltrials.gov/study/NCT03260023?tab=results"},{"endpoint":"Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification","primary":true,"unit":"months","arms":[{"name":"Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab","n":25,"value":4.3,"note":"90% CI 1.7 to 12.7; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication"},{"name":"Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab","n":24,"value":2.1,"note":"90% CI 1.4 to 2.8"},{"name":"Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab","n":14,"value":3,"note":"90% CI 1.5 to 5.6"},{"name":"Phase II Part 2 - Cohort A - Anal Cancer - Avelumab","n":13,"value":3,"note":"90% CI 1.4 to NA"},{"name":"Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab","n":7,"value":1.6,"note":"90% CI 1.4 to 5.6"},{"name":"Phase II Part 2 - Cohort A - Genital Cancer - Avelumab","n":7,"value":7.2,"note":"90% CI 2.8 to NA"}],"source":"https://clinicaltrials.gov/study/NCT03260023?tab=results"}]},"route":"/trials/nct03260023/","neighbours":{"cancer":[{"id":"node-positive-penile-cancer","kind":"cancer","name":"Node-positive and metastatic penile cancer","route":"/cancers/node-positive-penile-cancer/"},{"id":"penile","kind":"cancer","name":"Penile cancer","route":"/cancers/penile/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"avelumab","kind":"drug","name":"Avelumab","route":"/drugs/avelumab/"}],"company":[{"id":"transgene","kind":"company","name":"Transgene","route":"/companies/transgene/"}]}}