A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER

Launched by HOSPITAL ISRAELITA ALBERT EINSTEIN · Jul 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with advanced or returning vulvar cancer who have already completed chemotherapy. Specifically, it is looking at whether adding a medication called cemiplimab as a “maintenance” therapy—given after initial chemotherapy—can help keep the cancer under control longer compared to just providing the best supportive care, which focuses on managing symptoms and overall well-being. Cemiplimab is given through an IV every three weeks for up to 24 weeks, and patients who benefit may continue treatment up to 48 weeks.

Women eligible for this study are those aged 18 or older who have vulvar squamous cell carcinoma that has advanced or returned after treatment and who have completed 4 to 6 cycles of platinum-based chemotherapy without the cancer getting worse. Participants must have a good overall health status and no serious ongoing side effects from previous treatments. Those who join will be randomly assigned to either receive cemiplimab plus supportive care or just supportive care alone. The goal is to see if cemiplimab can help prevent the cancer from coming back or getting worse while maintaining quality of life. This study is not yet recruiting but will include about 42 participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1) Female participants. 2) At least 18 years old on the day of signing the informed consent. 3) Histologically confirmed diagnosis of vulvar squamous cell carcinoma, clinical stages III-IVA or recurrent disease not amenable to curative-intent therapy, or metastatic disease (stage IVB) - according to FIGO 2018 (International Federation of Gynecology and Obstetrics).4) Measurable disease (as per RECIST v1.1) prior to starting first-line chemotherapy. Lesions located in a previously irradiated area are deemed as measurable if progression has been shown in such lesions. 5) Previous chemotherapy performed in localized disease setting, with curative intent and platinum-based is allowed, provided that the time off this treatment is longer than 6 months. 6) Previous first-line chemotherapy should have been comprised of at least 4 cycles and no more than 6 platinum-based chemotherapy cycles. 7) No evidence of progressive disease after completing first-line chemotherapy (e.g., ongoing complete response (CR), (partial response) PR or stable disease (SD) as per RECIST v1.1 guidelines). 8) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
• Exclusion Criteria:
• • 1) History of allergy or hypersensitivity to the study drug components. 2) Persisting NCI CTCAE v5.0 Grade \> 1 toxicity related to previous therapy; however, Grade ≤ 2 sensory neuropathy and Grade ≤ 2 chronic kidney disease are acceptable. 3) Previous immune therapy with IL-2, IFN-α, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-T cytotoxic lymphocyte related to antigen-4 (CTLA-4), or any other antibody or drug specifically targeted to T-cell co-stimulation or immune checkpoint pathways. 4) Untreated or active primary brain tumor, metastases to central nervous system, leptomeningeal disease or spinal cord compression. 5) History of allogenic organ transplant. 6) Ongoing or recent evidence (within 5 years) of significant autoimmune disease requiring treatment with systemic immunosuppressants. 7) History of other primary malignancy within the last 3 years, except locally curable cancers which have been apparently cured, such as skin basal- or squamous-cell cancer, superficial bladder cancer, breast carcinoma in situ or cervical carcinoma in situ. 8) Uncontrolled infection by human immunodeficiency virus, hepatitis B or C infection; or immunodeficiency diagnosis. 9) Have received a live vaccine within 4 weeks of the planned start of the study drug. 10) Have received any previous systemic biological therapy within 5 half-lives of the first study therapy dose.
• • Exception: participants previously treated with bevacizumab, cetuximab, rituximab or other non-immunomodulating antibodies with half-lives longer than 7 days are allowed after a discussion with the sponsor, if at least 28 days have elapsed since last treatment. 11) Pregnant or breastfeeding women.