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Molecular Profile Unknown unknown
Therapy Ipilimumab + Nivolumab
Indication/Tumor Type renal cell carcinoma
Response Type not applicable

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown renal cell carcinoma not applicable Ipilimumab + Nivolumab Phase I Actionable In a Phase I trial, the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) demonstrated safety using 2 different dosing regimens (N3I1=nivolumab 3mg/kg+ipilumumab 1mg/kg; N1I3=nivolumab 1mg/kg+ipilumumab 3mg/kg) in patients with metastatic renal cell carcinoma, and resulted in an objective response rate of 40.4% (19/47) in both N3I1 and N1I3 arms and a 2-year overall survival of 67% in the N3I1 arm and 70% in the N1I3 arm (PMID: 28678668; NCT01472081). 28678668
Unknown unknown renal cell carcinoma not applicable Ipilimumab + Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 214) that supported FDA approval, the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) resulted in improved median overall survival (not reached vs. 26.0 months), objective response rate (42%, 40 complete responses (CR), vs. 27%, 5 CR), and progression-free survival (11.6 vs 8.4 months) compared to Sutent (sunitinib) in patients with intermediate or poor risk renal cell carcinoma (PMID: 29562145; NCT02231749). 29562145 detail... detail...
PubMed Id Reference Title Details
(28678668) Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study. Full reference...
(29562145) Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. Full reference...
Opdivo (nivolumab) FDA Drug Label Full reference...
Yervoy (ipilimumab) FDA Drug Label Full reference...