NIVOLUMAB for Vulvar squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- I1. Female patient ≥ 18 years of age on day of signing informed consent."}
• {"criterion_text":"- 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 •\tClinically 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- I4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2"}
• {"criterion_text":"- I5. Patients with adequate organ function: Absolute Neutrophil Count (ACN) ≥ 1 109/L, Platelets ≥ 100 109/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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- I8. Patients must be covered by a medical insurance."}

Exclusion criteria

• {"criterion_text":"- E1. Patients participating in another clinical trial with therapeutic intent."}
• {"criterion_text":"- E10. Pregnant or breastfeeding women."}
• {"criterion_text":"- E2. Patients previously treated with any anti-cancer treatment including anti-PD-1, anti-PD-L1, 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)."}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- E5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- E7. Patients with prior organ or bone marrow transplant."}
• {"criterion_text":"- E8. Patients with known active hepatitis B, C, or HIV infection or any active infection requiring systemic therapy."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Safety run-in: 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 (see protocol)","definition_or_measurement_approach":"DLT occurring during first 6 weeks (induction period), graded per NCI-CTCAE v6.0."}
• {"endpoint_text":"- Phase 2: Clinical ORR as per RECIST 1.1 category documented by calipers using standardized digital photography with reference ruler at the time of surgery","definition_or_measurement_approach":"Clinical overall response rate (ORR) assessed per RECIST 1.1 categories; documented by caliper measurements and standardized digital photography with reference ruler at time of surgery."}

Secondary endpoints

• {"endpoint_text":"- Pathological response: The pathological tumor response (pTR) is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (<10%), pTR-1 (10%-49%), pTR-2 (≥50%), pTR-3 (100%, complete response) The pTR will be quantified in increments of 10%.","definition_or_measurement_approach":"pTR quantified as percentage of tumor bed (pathologic response area / (pathologic response area + viable tumor)); categories pTR-0 to pTR-3; quantified in 10% increments."}
• {"endpoint_text":"- Rate of patients with positive margin defined as <8mm","definition_or_measurement_approach":"Positive surgical margin defined as margin < 8 mm; rate of patients meeting this definition."}
• {"endpoint_text":"- Rate of patients with positive Sentinel Lymph Node (SLN)","definition_or_measurement_approach":"Proportion of patients with pathologically positive sentinel lymph node."}
• {"endpoint_text":"- Rate of patients undergoing radiotherapy","definition_or_measurement_approach":"Proportion of patients who receive radiotherapy as part of treatment."}
• {"endpoint_text":"- Surgical complications: see section 7.7 of protocol","definition_or_measurement_approach":"Surgical complications assessed per definitions provided in protocol section 7.7."}
• {"endpoint_text":"- Overall Survival (OS): defined as the time between treatment initiation (C1D1) and death from any cause. Patients still alive at the time of analysis will be censored at the date of last news they are known to be alive.","definition_or_measurement_approach":"Time from C1D1 to death from any cause; censoring at date last known alive."}
• {"endpoint_text":"- Recurrence Free Survival (RFS): defined as the time from C1D1 to the first documented disease recurrence or death from any cause, whichever occurs first. Patients who are alive and without evidence of recurrence at the time of analysis will be censored at the date of their last disease assessment.","definition_or_measurement_approach":"Time from C1D1 to first documented recurrence or death; censoring at last disease assessment if alive without recurrence."}
• {"endpoint_text":"- Quality of life questionnaire (EORTC QLQ C-30 and QLQ-VU34)","definition_or_measurement_approach":"Patient-reported QoL assessed using EORTC QLQ-C30 and QLQ-VU34 questionnaires."}
• {"endpoint_text":"- Safety: Incidence and severity of AE according to NCI CTCAE V6.0","definition_or_measurement_approach":"Adverse events recorded and graded per NCI CTCAE v6.0; incidence and severity summarized."}

France

Earliest CTIS Part Ii Submission Date

13-04-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

9

Number Of Sites

3

Number Of Participants

50

Primary sponsor

Full Name

Centre Leon Berard

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"PHRC interrégional","duties_or_roles":"Source of monetary support","organisation_type":""}