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Molecular Profile Unknown unknown
Therapy Nivolumab
Indication/Tumor Type melanoma
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 melanoma not applicable Nivolumab Phase II Actionable In a Phase II trial, Opdivo (nivolumab) monotherapy resulted an overall response rate (ORR) of 25% (3/12) and pathologic complete response rate (pCR) of 25% (3/12) in patients with stage III or IV melanoma, compared to a ORR of 73% (8/11) and pCR of 45% (5/11) with the combination of Opdivo (nivolumab) and Yervoy (ipilimumab), but demonstrated lower toxicity than the combination therapy (PMID: 30297909; NCT02519322). 30297909
Unknown unknown melanoma not applicable Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 238) that supported FDA approval, adjuvant Opdivo (nivolumab) treatment resulted in improved rate of recurrence-free survival at 12-month compared to Yervoy (ipilimumab) (70.5% vs 60.8%, HR=0.65, P<0.001) in patients with resected stage III or IV melanoma (PMID: 28891423, NCT02388906). detail... 28891423
Unknown unknown melanoma not applicable Nivolumab Phase III Actionable In an analysis of two Phase III trial, Opdivo (nivolumab) treatment after disease progression demonstrated safety and clinical benefit, with 76% (65/85) of patients still alive at time of analysis in melanoma patients who received the last dose of Opdivo (nivolumab) more than 6 weeks after progression (PMID: 28662232). 28662232
Unknown unknown melanoma not applicable Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 037) that supported FDA approval, 31.7% (38/120) of patients with advanced melanoma treated with Opdivo (nivolumab) experienced an objective response whereas only 10.6% (5/47) of advanced melanoma patients treated with investigator's choice of therapy demonstrated an objective response (PMID: 25795410; NCT01721746). 25795410 detail...
PubMed Id Reference Title Details
(25795410) Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Full reference...
(28662232) Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. Full reference...
(28891423) Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. Full reference...
(30297909) Neoadjuvant immune checkpoint blockade in high-risk resectable melanoma. Full reference...
Opdivo (nivolumab) FDA Drug Label Full reference...
Opdivo (nivolumab) FDA Drug Label Full reference...