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NCT03260023 · ClinicalTrials.gov registry record · Phase 1
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
A Phase 1 study of HPV-Related Carcinoma and HPV-Related Cervical Carcinoma, sponsored by Transgene.
- Active
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
- 20
- Study locations
NCT03260023 is a Phase 1 study of HPV-Related Carcinoma and HPV-Related Cervical Carcinoma that is active but no longer recruiting, run by Transgene. The registered enrollment target is 143 participants, roughly in line with the 141-participant average among 10 other HPV-Related Carcinoma trials with a reported enrollment target. The trial reports 20 study locations across 3 states.
The verdict
NCT03260023, a Phase 1 study of HPV-Related Carcinoma and HPV-Related Cervical Carcinoma, is active but no longer recruiting, sponsored by Transgene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 141-participant average among 10 other HPV-Related Carcinoma trials with a reported enrollment target. The listed sponsor is Transgene, which has 7 total studies on file at ClinicalTrials.gov.
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.
NCT03260023 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Other, Florida, Minnesota.
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.
What interventions are being tested in trial NCT03260023?
The interventions under investigation include: Avelumab (DRUG), TG4001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03260023?
This trial is sponsored by Transgene, which has 7 total clinical trials registered on ClinicalTrials.gov.
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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