Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma

Cannot have received: anti-PD-1 therapy (nivolumab)

Exception: prior adjuvant PD-1 blockade permitted

Prior therapy with an anti-PD-1 (including nivolumab)... Prior adjuvant PD-1 blockade (but not prior adjuvant Cytotoxic T lymphocyte-associated antigen (CTLA)-4 blockade) is permitted

Cannot have received: anti-PD-L1 therapy

Prior therapy with...anti-programmed death ligand (anti-PD-L1, anti-PDL2...) agents

Cannot have received: anti-PD-L2 therapy

Prior therapy with...anti-programmed death ligand (anti-PD-L1, anti-PDL2...) agents

Cannot have received: anti-CTLA-4 therapy (ipilimumab)

Exception: prior adjuvant CTLA-4 blockade permitted

Prior therapy with...anti-CTLA4 (including ipilimumab)... Prior adjuvant PD-1 blockade (but not prior adjuvant Cytotoxic T lymphocyte-associated antigen (CTLA)-4 blockade) is permitted

Cannot have received: interferon

Prior therapy with...interferon

Cannot have received: HD IL-2

Prior therapy with...HD IL-2

Cannot have received: checkpoint inhibitor

any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Cannot have received: chemotherapy

Exception: within 2 weeks prior to first dose of nivolumab/ipilimumab or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Prior chemotherapy, targeted small molecule therapy or other anti-cancer therapy within 2 weeks prior to first dose of nivolumab/ipilimumab or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Cannot have received: targeted small molecule therapy

Exception: within 2 weeks prior to first dose of nivolumab/ipilimumab or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Prior chemotherapy, targeted small molecule therapy or other anti-cancer therapy within 2 weeks prior to first dose of nivolumab/ipilimumab or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Cannot have received: anti-cancer therapy

Exception: within 2 weeks prior to first dose of nivolumab/ipilimumab or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Prior chemotherapy, targeted small molecule therapy or other anti-cancer therapy within 2 weeks prior to first dose of nivolumab/ipilimumab or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Cannot have received: investigational agent

Exception: within 4 weeks prior to first dose of nivolumab/ipilimumab

Treatment with any other investigational agent within 4 weeks prior to first dose of nivolumab/ipilimumab

Cannot have received: radiotherapy

Exception: prior radiotherapy that precludes the proposed treatment with HFRT or any radiotherapy within 28 days of first dose of nivolumab/ipilimumab

Prior radiotherapy that precludes the proposed treatment with HFRT or any radiotherapy within 28 days of first dose of nivolumab/ipilimumab