M.D. Anderson Cancer Center
To find out if the combination of HC-7366 and nivolumab (with or without ipilimumab) can help to control ccRCC. The
Primary Objectives To assess two combinations of HC-7366: * Doublet Cohort: HC-7366 with nivolumab monotherapy * Triplet Cohort: HC-7366 with nivolumab/ipilimumab dual immune checkpoint inhibition * For safety through assessment of trial-limiting toxicities including need for high dose corticosteroids (= 40 mg prednisone equivalents for two weeks or more) * For antitumor activity through assessment of Overall response rate (ORR) and Disease control rate (DCR: CR or partial response (PR) or stable disease (SD)) per RECIST v1.1 Secondary Objectives The secondary objectives of the study a…
Eligibility Criteria 1. Ability to understand and the willingness to sign a written informed consent document 2. Male or female ≥ 18 years of age 3. Confirmed diagnosis of clear cell RCC 4. Stage IV metastatic RCC per American Joint Committee on Cancer 5. Triplet Cohort (IO/IO): No prior systemic therapy for advanced RCC or prior adjuvant therapy allowed. 6. Doublet Cohort: Participant must have progressed on at least one PD1 based doublet regimen (IO/IO or IO/TKI). Prior adjuvant therapy is allowed and does count as one line of systemic therapy. 7. Eastern Cooperative Oncology Group (ECOG) p…
Given by IV
Given by po
Given by IV
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