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Fig. 1 | BMC Cancer

Fig. 1

From: A multicenter open-label phase II trial to evaluate nivolumab and ipilimumab for 2nd line therapy in elderly patients with advanced esophageal squamous cell cancer (RAMONA)

Fig. 1

Study scheme. Patients may be escalated to nivolumab/ipilimumab combination therapy after a 3 cycle nivolumab-only run-in phase and positive safety assessment. GA: geriatric assessment (G8 / DAFI). ***: treatment escalation according to safety assessment results (please see full protocol). **: Chemotherapy (+/− radiotherapy) (e.g. CROSS, FLOT or similar protocols) OR any palliative systemic chemotherapy. * Stage 4 OR stage 3 non-responder to radio-chemotherapy OR any relapse after chemo-radiation OR any relapse after surgery if patient is ineligible or intolerant to standard frontline therapy OR refuses other treatment. PD1: off study despite post-progression ipi/nivo in case of toxicity and/or clinical deterioration. PD2: off study if confirmed progression according to Recist criteria V 1.1 or non-response according to immune-related response criteria. Ipilimumab 1 mg/kg IV Q6W. Nivolumab 240 mg IV Q2W. Restaging (incl. Endoscopic biopsies +PD-L1 staining)

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