M.D. Anderson Cancer Center
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).
Primary Objectives • To determine the objective response rate (ORR) and disease control rate (DCR), per RECIST 1.1, of ubamatamab alone and in combination with cemiplimab in patients with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies, RMC or ES, who have progressed on at least one prior line of therapy. Secondary Objectives • To determine the efficacy and safety of ubamatamab alone or in combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies such as RMC or ES who have progressed on at le…
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 tis…
Given by IV
Given by IV
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