# Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

Source: https://onco.cc/trials/nct03260023/  
OnCo record `nct03260023` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: ctgov-ingest
- Registry id: 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
- Enrolled: 143
- Outcomes: Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1, Overall Response Rate: Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab 16.67%; Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1: Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab 3 months vs Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab 2.8 months, HR 0.87; Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification: Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab 4.3 months vs Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab 2.1 months vs Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab 3 months vs Phase II Part 2 - Cohort A - Anal Cancer - Avelumab 3 months vs Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab 1.6 months vs Phase II Part 2 - Cohort A - Genital Cancer - Avelumab 7.2 months

## Sources

- ClinicalTrials.gov NCT03260023: https://clinicaltrials.gov/study/NCT03260023

## Connected records

- cancers: [Node-positive and metastatic penile cancer](https://onco.cc/cancers/node-positive-penile-cancer/), [Penile cancer](https://onco.cc/cancers/penile/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Avelumab](https://onco.cc/drugs/avelumab/)
- companies: [Transgene](https://onco.cc/companies/transgene/)

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