Trials / Completed
CompletedNCT04357873
Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations
Phase II Basket Trial Evaluating the Efficacy of a Combination of Pembrolizumab and Vorinostat in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Interventional study evaluating the efficacy of an immunotherapy (pembrolizumab) in combination with a targeted therapy (vorinostat) in patient with recurrent and/or metastatic squamous cell carcinoma (localisations : head and neck, lung, cervix, anus, vulva, and penis)
Detailed description
Open-label, non-randomized, multi-center, basket phase II trial, evaluating the efficacy of pembrolizumab in combination with vorinostat in adult patients with recurrent and/or metastatic squamous cell carcinoma of different locations. Antitumor activity of the combination will be evaluated using the objective response rate (ORR) during treatment (investigator assessment).
Conditions
- Squamous Cell Lung Cancer
- Vulvar Cancer
- Penile Cancer
- Cervix Cancer
- Head and Neck Squamous Cell Carcinoma
- Anal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pembrolizumab; vorinostat | Pembrolizumab: 200 mg every 3 weeks, up to 35 administrations Vorinostat: 400 mg once daily, until progression |
Timeline
- Start date
- 2020-10-28
- Primary completion
- 2022-12-15
- Completion
- 2024-11-26
- First posted
- 2020-04-22
- Last updated
- 2025-02-19
Locations
14 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04357873. Inclusion in this directory is not an endorsement.