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Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) Versus Observation

Primary Objective To demonstrate an absolute improvement in Neoadjuvant Rectal Cancer (NAR) score for the experimental regimen as compared to concurrently randomized control patients. Secondary Objectives To compare overall survival (OS) To compare disease-free survival (DFS) To compare the rate of pathologic complete response (nodes and tumor) Pathologic response to preoperative therapy will be determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). To compare the rate of sphincter preservation Exploratory Objectives To estimate the rate of disease progression during chemotherapy (prior to chemoradiation) To compare the rate of clinical complete response rate (cCR) Presence or absence of complete clinical response will be assessed immediately prior to surgery by perioperative digital rectal exam and either sigmoidoscopy or proctoscopy. Clinical complete response (cCR) is defined as no visible or palpable rectal primary tumor. To compare the rate of negative circumferential margin To compare the rate of completion of all cycles of neoadjuvant chemotherapy To compare the rate of completion of full course of chemoradiation To compare the toxicity and safety between interventions To explore the correlative molecular predictors of response and distant failure To explore the relationship between radiographic findings and pathologic outcomes

Primary Objective To demonstrate an absolute improvement in Neoadjuvant Rectal Cancer (NAR) score for the experimental regimen as compared to concurrently randomized control patients. Secondary Objectives To compare overall survival (OS) To compare disease-free survival (DFS) To compare the rate of pathologic complete response (nodes and tumor) Pathologic response to preoperative therapy will be determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). To compare the rate of sphincter preservation Exploratory Objectives To estimate the rate of disease progression during chemotherapy (prior to chemoradiation) To compare the rate of clinical complete response rate (cCR) Presence or absence of complete clinical response will be assessed immediately prior to surgery by perioperative digital rectal exam and either sigmoidoscopy or proctoscopy. Clinical complete response (cCR) is defined as no visible or palpable rectal primary tumor. To compare the rate of negative circumferential margin To compare the rate of completion of all cycles of neoadjuvant chemotherapy To compare the rate of completion of full course of chemoradiation To compare the toxicity and safety between interventions To explore the correlative molecular predictors of response and distant failure To explore the relationship between radiographic findings and pathologic outcomes