Moffitt logo

Clinical Trials Search

Clinical Trial 19693

Cancer Type: Gastrointestinal Tumor
Interventions:

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Rutika Mehta

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Randomized Phase 3 Study of Nivolumab plus Ipilimumab or Nivolumab Combined with Fluorouracil plus Cisplatin versus Fluorouracil plus Cisplatin in Subjects with Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

Summary

Objective

Primary Objectives To compare the OS of nivolumab plus ipilimumab (Arm A) to fluorouracil plus cisplatin chemotherapy (Arm C) in subjects with PD-L1 expression d 1%. To compare the OS of nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil plus cisplatin chemotherapy (Arm C) in subjects with PD-L1 expression d 1%. To compare the PFS of nivolumab plus ipilimumab (Arm A) to fluorouracil and cisplatin combination (Arm C) as assessed by a BICR in subjects with PD-L1 expression d 1%. To compare the PFS of nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil and cisplatin combination (Arm C) as assessed by a BICR in subjects with PD-L1 expression d 1%. Secondary Objectives To compare the OS of nivolumab plus ipilimumab (Arm A) and nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil and cisplatin combination (Arm C) in all randomized subjects. To compare the PFS of nivolumab plus ipilimumab (Arm A) and nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil and cisplatin combination (Arm C) as assessed by a BICR in all randomized subjects. To compare the objective response rate (ORR) of nivolumab plus ipilimumab (Arm A) and nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil and cisplatin combination (Arm C) as assessed by a BICR in subjects with PD-L1 expression d 1%. To compare the ORR of nivolumab plus ipilimumab (Arm A) and nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil and cisplatin combination (Arm C) as assessed by a BICR in all randomized subjects.

Inclusion Criteria

  • Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
  • Male or Female at least 18 years of age
  • Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

  • Exclusion Criteria

  • Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
  • Active known or suspected autoimmune disease
  • Any serious or uncontrolled medical disorder or active infection
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus
  • Other protocol defined inclusion/exclusion criteria could apply