Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

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PRIMARY OBJECTIVES: I. To assess the pathologic complete response rate (pathCR) rate following administration of neoadjuvant carboplatin, paclitaxel and radiation therapy versus neoadjuvant carboplatin, paclitaxel, radiation therapy and nivolumab in patients with a resected locoregionally advanced e...

PRIMARY OBJECTIVES: I. To assess the pathologic complete response rate (pathCR) rate following administration of neoadjuvant carboplatin, paclitaxel and radiation therapy versus neoadjuvant carboplatin, paclitaxel, radiation therapy and nivolumab in patients with a resected locoregionally advanced esophageal or gastroesophageal junction adenocarcinoma. II. To assess the disease-free survival (DFS) following administration of adjuvant nivolumab and ipilimumab versus adjuvant nivolumab in patients with a resected locoregionally advanced esophageal or gastroesophageal junction adenocarcinoma who received neoadjuvant treatment with carboplatin, paclitaxel and radiation therapy with or without nivolumab. SECONDARY OBJECTIVES: I. To assess the overall survival (OS) following administration of adjuvant nivolumab and ipilimumab versus nivolumab in patients with a resected locoregional esophageal or gastroesophageal junctional adenocarcinoma who received neoadjuvant treatment with carboplatin, paclitaxel and radiation therapy with or without nivolumab. II. To assess the disease free survival (DFS) following administration of neoadjuvant carboplatin, paclitaxel, and radiation therapy with or without nivolumab in patients with a locoregional esophageal or gastroesophageal junction adenocarcinoma III. To assess the toxicity associated with the administration of neoadjuvant nivolumab in combination with carboplatin, paclitaxel and radiation therapy in patients with a locoregional esophageal or gastroesophageal junction adenocarcinoma. IV. To assess the toxicity associated with the administration of adjuvant nivolumab and ipilimumab versus adjuvant nivolumab in patients with a resected locoregional esophageal or gastroesophageal junction adenocarcinoma who received neoadjuvant treatment with carboplatin, paclitaxel and radiation therapy with or without nivolumab. IMAGING OBJECTIVES: I. To determine if the percent change in mean volumetric apparent diffusion coefficient (ADC), measured from pre-treatment to mid-treatment, is predictive of pathCR in patients with a locoregional esophageal or gastroesophageal junctional adenocarcinoma undergoing chemo and chemoradiotherapy plus (+)/minus (-) nivolumab. II. To identify an optimal delta ADC cutoff in predicting pathCR. OUTLINE: STEP I: Patients are randomized to 1 of 2 arms. ARM A: Patients receive carboplatin intravenously (IV) and paclitaxel IV once weekly and undergo radiation therapy once daily (Monday-Friday) beginning on day 1. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive carboplatin, paclitaxel, and radiation therapy as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. STEP II: Patients are randomized to 1 of 2 arms following standard of care surgery. ARM C: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. ARM D: Patients receive nivolumab as in Arm C and receive ipilimumab IV over 90 minutes on day 1 of cycles 1, 4, 7, and 10. Treatment repeats every 2 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for up to 5 years.

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