Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To determine the median immune-related progression-free survival (irPFS) in the experimental arms. SECONDARY OBJECTIVES: I. To determine the rate of grade III or higher treatment related toxicity in each experimental arm. II. To describe the immunological and gene expression c...

PRIMARY OBJECTIVES: I. To determine the median immune-related progression-free survival (irPFS) in the experimental arms. SECONDARY OBJECTIVES: I. To determine the rate of grade III or higher treatment related toxicity in each experimental arm. II. To describe the immunological and gene expression changes induced by tremelimumab and the combination of tremelimumab and durvalumab in epithelial ovarian cancer (EOC) tumor tissues and blood. III. To determine the median overall survival (OS), objective response rate (ORR), and irPFS rate at 10 months. IV. To determine the proportion of patients that discontinue treatment due to side effects. EXPLORATORY OBJECTIVES: I. To determine second progression-free survival (PFS) (PFS2) following initial progression in each arm. II. To determine the response rate to durvalumab (MEDI4736) following treatment with tremelimumab (in the sequential arm). III. To evaluate the patient reported symptom burden in each experimental arm. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (SEQUENTIAL): Participants receive tremelimumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Participants then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. ARM II (COMBINATION): Participants receive tremelimumab IV and durvalumab IV over 60 minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Participants then receive durvalumab IV on day 1. Treatment repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. After study treatment, participants are followed up at 30 days and then every 2 months thereafter.

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