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OncoMatch/Clinical Trials/NCT05932212

AK104 for Recurrent or Metastatic Vulvar Cancer

Is NCT05932212 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AK104 and AK104+ Paclitaxel+Cisplatin or Carboplatin for vulvar cancer.

Phase 2RecruitingAkesoNCT05932212Data as of May 2026

Treatment: AK104 · AK104+ Paclitaxel+Cisplatin or CarboplatinThis is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.

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Extracted eligibility criteria

Cancer type

Cervical Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: systemic therapy

should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy

Cannot have received: immune checkpoint inhibitor

Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.)

Cannot have received: systemic or curative (surgery or radiotherapy) anti-tumor therapy

Systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration

Lab requirements

Blood counts

Adequate organ function as assessed in the laboratory tests

Kidney function

Adequate organ function as assessed in the laboratory tests

Liver function

Adequate organ function as assessed in the laboratory tests

Adequate organ function as assessed in the laboratory tests

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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