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COLOMBE - A multicentre, single arm, phase 1/2 study, aiming to assess the safety and efficacy of nivolumab and imiquimod combination in vulvar squamous cell carcinoma patients
EU CTIS ID: 2025-524759-29-00
What this study is testing
Phase I : Safety run-in: to evaluate the safety of imiquimod and nivolumab combination in adult patients with resectable primary VSCC Phase 2: to evaluate the clinical efficacy of imiquimod and nivolumab combination in adult patients with resectable primary VSCC
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (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
- 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.
You likely can't join if
- E1. Patients participating in another clinical trial with therapeutic intent.
- E10. Pregnant or breastfeeding women.
- 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).
- 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.
See the full eligibility criteria
Who can join
- 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 (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
- 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.
What rules you out
- E1. Patients participating in another clinical trial with therapeutic intent.
- E10. Pregnant or breastfeeding women.
- 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).
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.