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Starting soon Phase 1/2

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

NCT07679841 · tracked via the Priya Life Science France tracker
Phase
Phase 1/2
Started
2026-09
Last updated
2026-09-30

Condition(s) studied

Vulvar Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Imiquimod 5% cream →Nivolumab →

Imiquimod 5% cream: 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: At DL1 and DL-1: Administration IV at a dose of 40 mg, every two weeks for 6 weeks (3 doses)

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: I1. Female patient ≥ 18 years of age on day of signing informed consent. I2. Histologically confirmed primary VSCC, with all of the following characteristics: * At least 1 lesion that can be measured in at least 1 dimension with ≥ 10 mm in largest diameter * Clinically stage FIGO I-III (2021 FIGO staging) * Eligible for primary tumour surgery * Surgical complexity due to either bulky tumors \> 4 cm OR multifocal tumor (defined as the presence of two or more foci of cancer on the vulva), the largest lesion must be ≥ 10 mm and all lesions ≥ 10 mm are designated as "target" lesion(s) for all subsequent tumor evaluations OR any tumor for which a surgical excision would have anatomical or functional consequences deemed significant by the treating surgeon I3. Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary tumor tissue (biopsy) with an associated pathology report. This tumor sample must meet the following quality/quantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2 I4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 I5. Patients with adequate organ function: * Absolute Neutrophil Count (ANC) ≥ 1 10\^9/L * Platelets ≥ 100 10\^9/L (without transfusion for platelets within 7 days) * Hemoglobin ≥ 9 g/dL * Creatinine clearance according to CKD-EPI ≥ 30 mL/min * Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) * AST and ALT ≤ 3 x ULN I6. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to C1D1 and must agree to use effective forms of contraception from the time of the negative pregnancy test up to 5 months after the last dose of nivolumab. I7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. I8. Patients must be covered by a medical insurance. Exclusion Criteria: E1. Patients participating in another clinical trial with therapeutic intent. E2. Patients previously treated with any anti-cancer treatment including anti-PD-1, anti-PDL1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX 40, CD37). E3. Patients not respecting the minimal washout period or receiving or anticipation of need during the study of the following medications/procedure: * Major surgery: 2 weeks * Live vaccines: 4 weeks * Systemic corticosteroids (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy: 1 week E4. Patients with known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin on a location other than the vulva, or carcinoma in situ (e.g. of the breast, cervix or bladder) that have undergone potentially curative therapy are not excluded. E5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. E6. Patients with evidence of significant uncontrolled infection or concomitant disease, or psychiatric illness/social situations that could affect compliance with the protocol or interpretation of results. E7. Patients with prior organ or bone marrow transplant. E8. Patients with known active hepatitis B, C, or HIV infection or any active infection requiring systemic therapy. E9. Patients with known or suspected active autoimmune disease. Note: Patients with skin disorders (such as vitiligo, psoriasis or alopecia), type I diabetes mellitus, hypothyroidism only requiring hormone replacement or conditions not expected to recur in the absence of an external trigger are eligible. E10. Pregnant or breastfeeding women.

Primary outcome measure(s)

  • 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) — From Cycle 1 Day 1 to week 6
    Dose-limiting toxicity (DLT) defined as any adverse event (AE) related to imiquimod and/or nivolumab, occurring during the induction period (first 6 weeks of treatment, i.e., DLT period) and graded according to the NCI-CTCAE V6.0 classification: * Grade 4 non-laboratory AE including skin toxicity; * Grade 3 non-laboratory AE lasting \>14 days despite optimal supportive care with the following exceptions: Influenza-like symptoms and application site reaction related to imiquimod * Any grade 3 or grade 4 laboratory value with clinical symptoms requiring medical intervention or hospitalization, and persisting for more than 14 days; * Any imiquimod site application AE or nivolumab related AE postponing the surgery of at least 14 days * Any other AE evaluated as clinically significant by investigator and sponsor, for instance delaying the nivolumab administration for more than 14 days * Any toxic death, grade 5 AE
  • Phase II: To evaluate the clinical efficacy of imiquimod and nivolumab combination in adult patients with resectable primary VSCC — From Cycle 1 Day 1 to surgery (up to 3 cycles - each cycle is 14 days)
    Clinical ORR (objective response rate) as per RECIST 1.1 category documented by calipers using standardized digital photography with reference ruler at the time of surgery

Trial sites (11)

FacilityCityRegionStatus
CH de Bourg-en-Bresse Bourg-en-Bresse France
Centre Jean Perrin Clermont-Ferrand France
CHU Clermont-Ferrand Clermont-Ferrand France
Groupe Hospitalier Mutualiste de Grenoble Grenoble France
Centre Oscar Lambret Lille France
Centre Léon Bérard Lyon France
HCL - Centre Hospitalier Lyon Sud Lyon France
Hôpital Privé Jean Mermoz Lyon France
Institut Paoli-Calmettes Marseille France
CHU de Saint Etienne Saint-Priest-en-Jarez France
IUCT Oncopole Claudius Regaud Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07679841 on ClinicalTrials.gov ↗ ← All trials in France