Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
Trial Parameters
Brief Summary
To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).
Eligibility Criteria
Inclusion Criteria: 1. Participants with locally advanced or metastatic RMC (RMC cohort) or ES (ES cohort) histologically confirmed by expert pathology review and loss of SMARCB1 staining by IHC. Participants with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible for the RMC cohort. 2. Eligible participants should either demonstrate serum CA-125 levels ≥ 70 units/ml during screening or positive H score of \>25 for MUC16 (CA-125) by IHC in tumor tissues collected within 12 months from screening as noted in participant EMR: 1. The H score is calculated using the standard formula commonly used in IHC: H score = \[(0 x % negative cells) + (1 x % weak positive cells) + (2 x % moderate positive cells) + (3 x % strong positive cells). For instance, if 50% of tumor cells show weak staining, 30% of tumor cells show moderate staining, and 20% of cells