Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations

Sponsor
UNICANCER
Study ID
NCT04357873
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pembrolizumab; vorinostat — DRUG
    Pembrolizumab: 200 mg every 3 weeks, up to 35 administrations Vorinostat: 400 mg once daily, until progression

Study Details

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)

Key Dates

Start date
Oct 28, 2020
Status verified
Feb 2024
Primary completion
Dec 15, 2022
Completion
Nov 26, 2024

Study Design

Enrollment
112 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pembrolizumab + vorinostat
    Pembrolizumab: 200 mg every 3 weeks, up to 35 administrations Vorinostat: 400 mg once daily, until progression

Primary Outcome Measure

Objective Response Rate (ORR), investigator assessment [ Time Frame: From inclusion to first and subsequent tumor assesment or progression, up to 24 months ]

Related Studies