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Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
NCT03260023 · View on ClinicalTrials.gov ↗
Study Summary
The study will consist of two parts : In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 participants at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-participant dose escalation. In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of participants with recurrent or metastatic HPV-16 positive advanced malignancies. In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in participants with HPV-16 positive advanced malignancies. In both phases, evaluation of tumor response will be done locally according to RECIST 1.1. All participants will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first.
Conditions Studied
Interventions
- DRUG Avelumab
- BIOLOGICAL TG4001
Study Locations (20)
Other
- I.C.O. Paul Papin — Angers
- CHU Besançon — Besançon
- Hôpital Saint André - CHU de Bordeaux — Bordeaux
- Hôpitaux Civils de Colmar - Hôpital Pasteur — Colmar
- CLCC Georges-François Leclerc — Dijon
- Centre Léon Bérard — Lyon
- Hopital de la Timone — Marseille
- Institut Curie — Paris
- I.C.O. Gauducheau — Saint-Herblain
- Centre Paul Strauss - ICANS - Institut de cancérologie Strasbourg Europe — Strasbourg
- Institut Claudius Regaud - IUCT - Oncopole — Toulouse
- Institut Gustave Roussy — Villejuif
- ICO Badalona - Hospital Germans Trias i Pujol — Badalona
- Hospital Virgen de las Nieves — Granada
- Fundación de Investigación biomédica H. 12 de Octubre — Madrid
- Fundación de Investigación Biomédica Hospital Clínico San Carlos — Madrid
- Hospital Virgen de La Victoria — Málaga
- Hospital General de Valencia — Valencia
Florida
- Mayo Clinic — Jacksonville
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03260023
The ClinicalTrials.gov registry entry for NCT03260023 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Transgene, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with HPV-Related Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Avelumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03260023 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03260023 about?
NCT03260023 is a clinical study titled "Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers". The study will consist of two parts : In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 participants at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-participant dose escalation. In the phase II part 1, evaluation ...
What is the current status of trial NCT03260023?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2017-09-01. Estimated completion is 2026-12.
What conditions does trial NCT03260023 study?
This clinical trial studies the following 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03260023?
The interventions under investigation include: Avelumab (DRUG), TG4001 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03260023?
This trial is sponsored by Transgene, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03260023 being conducted?
This trial has 20 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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