Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
← catalyst calendarSponsored by Transgene (industry) · TNG.PA — their whole pipeline →. With Merck KGaA, Darmstadt, Germany, EMD Serono Research & Development Institute, Inc., Pfizer.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
143actual
Sites
20
Countries
France, Spain, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-09-01 | actual | When the study began enrolling |
| Primary completion | 2024-09-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2017-08-24 | actual | When this record first appeared on the registry |
| Results posted | 2025-12-02 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- HPV-Related Carcinoma
- HPV-Related Cervical Carcinoma
- HPV-Related Anal Squamous Cell Carcinoma
- HPV-Related Penile Squamous Cell Carcinoma
- HPV-Related Vulvar Squamous Cell Carcinoma
Interventions
- Biological: TG4001
- Drug: Avelumab
Primary outcomes
what the primary-completion date above is the date OFPhase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies
measured From Day 1 to Day 28
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
measured From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.
Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1
measured From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification
measured From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2023-12-06 · 2.7 MB · Prot_SAP_002.pdf
Publications
- PMID 37506588 — reports results
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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