Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients

Sponsor
Centre Leon Berard
Study ID
NCT07679841
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Vulvar Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Imiquimod 5% cream — DRUG
    At the starting dose (DL1) : 5 consecutive days per week for 4 weeks At DL-1: 3 consecutive days per week for 4 weeks
  • Nivolumab — DRUG
    At DL1 and DL-1: Administration IV at a dose of 40 mg, every two weeks for 6 weeks (3 doses)

Study Details

COLOMBE is a multicenter, single arm, phase 1/2 trial designed to evaluate the safety and efficacy of imiquimod cream with IV low dose nivolumab in primary resectable vulvar squamous cell carcinoma patients prior to surgery, leveraging the preoperative "window of opportunity" period, an unavoidable interval due to surgical scheduling.

Key Dates

First listed
Jul 1, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adult female patient with VSCC
    Patients must have histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC).

Primary Outcome Measure

Phase I Safety run-in: Dose-limiting toxicity (DLT) related to imiquimod and/or nivolumab, occurring during the induction period (first 6 weeks of treatment) [ Time Frame: From Cycle 1 Day 1 to week 6 ]

Central Contacts

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