Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT03260023

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

A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions HPV-Related Anal Squamous Cell Carcinoma HPV-Related Carcinoma HPV-Related Cervical Carcinoma HPV-Related Penile Squamous Cell Carcinoma HPV-Related Vulvar Squamous Cell Carcinoma

Interventions Avelumab TG4001

Updated 21 times since 2017 Last updated: Jan 15, 2026 Started: Sep 1, 2017 Primary completion: Sep 18, 2024 Completion: Dec 31, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on HPV-Related Anal Squamous Cell Carcinoma and HPV-Related Carcinoma, this trial is ongoing. The trial is conducted by EMD Serono Research & Development Institute, Inc. and has accumulated 21 data snapshots since 2017. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

21 versions recorded

Feb 2026 — Present [monthly]

Active Not Recruiting PHASE1/PHASE2
Jan 2026 — Feb 2026 [monthly]

Active Not Recruiting PHASE1/PHASE2
Sep 2025 — Jan 2026 [monthly]

Active Not Recruiting PHASE1/PHASE2
Mar 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2
Sep 2024 — Mar 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2

▶ Show 16 earlier versions

Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
May 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Sep 2023 — May 2024 [monthly]

Recruiting PHASE1_PHASE2
Mar 2022 — Sep 2023 [monthly]

Recruiting PHASE1_PHASE2
Sep 2021 — Mar 2022 [monthly]

Recruiting PHASE1_PHASE2

Status: Active Not Recruiting → Recruiting
Apr 2021 — Sep 2021 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Jan 2021 — Apr 2021 [monthly]

Recruiting PHASE1_PHASE2
Nov 2019 — Jan 2021 [monthly]

Recruiting PHASE1_PHASE2
Oct 2019 — Nov 2019 [monthly]

Recruiting PHASE1_PHASE2
Sep 2019 — Oct 2019 [monthly]

Recruiting PHASE1_PHASE2
Apr 2019 — Sep 2019 [monthly]

Recruiting PHASE1_PHASE2
Jan 2019 — Apr 2019 [monthly]

Recruiting PHASE1_PHASE2
Jun 2018 — Jan 2019 [monthly]

Recruiting PHASE1_PHASE2
Dec 2017 — Jun 2018 [monthly]

Recruiting PHASE1_PHASE2
Oct 2017 — Dec 2017 [monthly]

Recruiting PHASE1_PHASE2

Status: Not Yet Recruiting → Recruiting
Sep 2017 — Oct 2017 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Pfizer
Transgene

Data source: Transgene

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Angers, France , Badalona, Spain , Besançon, France , Bordeaux, France , Colmar, France , Dijon, France , Granada, Spain , Jacksonville, United States , Lyon, France , Madrid, Spain and 9 more locations