Inclusion criteria | Exclusion criteria |
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Histologically or cytologically confirmed unresectable, incompletely resected, recurrent, or metastatic squamous cell carcinoma of the vulva. Patients with unresectable disease are defined as T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy | Patients who in the opinion of the investigator cannot safely receive a minimum of 30Â Gy in 10 fractions are not eligible for the trial |
Participants must have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions | Participants who have received prior systemic anti-cancer therapy including investigational agents within 4Â weeks prior to first dose of study treatment |
Documented Microsatellite stability status by routine methods including MMR IHC, MSI PCR or MSI by Next Generation Sequencing (NGS) | Participants who have received a live vaccine within 30Â days prior to the first dose of study drug |
Participants with no prior therapy are eligible and patients with recurrent disease must not have had more than two lines of cytotoxic therapy | Participants with a history of gastrointestinal or colovesicular fistulae |
ECOG performance status of 0 or 1 | Has active autoimmune disease that has required systemic treatment in the past 2Â years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) |
Absolute neutrophil count (ANC): ≥ 1500/µL Platelets: ≥ 100,000/µL Hemoglobin: ≥ 9.0 g/dL or ≥ 5.6 mmol/L Creatinine: ≤ 1.5 × ULN AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN Total bilirubin: ≤ 1.5 × ULN | Has known active CNS metastases and/or carcinomatous meningitis |