Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 58
Summary
- Conditions
- Platinum-Resistant Fallopian Tube Carcinoma
- Malignant Peritoneal Neoplasm
- Malignant Retroperitoneal Neoplasm
- Peritoneal Carcinomatosis
- Stage IVB Cervical Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Platinum-Resistant Ovarian Carcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Recurrent Cervical Carcinoma
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IVA Cervical Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Recurrent Endometrial Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Stage IV Fallopian Tube Cancer AJCC v8
- Recurrent Ovarian Carcinoma
- Stage IV Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IV Cervical Cancer AJCC v8
- Recurrent Primary Peritoneal Carcinoma
- Stage IVB Ovarian Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) of intraperitoneal (i.p.) nivolumab in combination with ipilimumab. SECONDARY OBJECTIVES: I. To describe the pharmacokinetics (PK), toxicities, and immune-related adverse events associated with i.p. checkpoint inhibitor therapy...
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) of intraperitoneal (i.p.) nivolumab in combination with ipilimumab. SECONDARY OBJECTIVES: I. To describe the pharmacokinetics (PK), toxicities, and immune-related adverse events associated with i.p. checkpoint inhibitor therapy. II. To estimate the clinical benefit rate (rate of partial response [PR], complete response [CR], and stable disease [SD] using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 modified to include immune-related response criteria) for the expansion cohort. EXPLORATORY OBJECTIVES: I. To determine blood based transcriptional changes associated with pharmacokinetics (PK) time points and determine their correlation with serum drug concentrations, clinical response, and immune related adverse events. II. To determine baseline and on-treatment molecular alteration (ribonucleic acid [RNA] and protein) associated with i.p. and nivolumab (Nivo) (for the expansion cohort). OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups. GROUP I: Patients receive nivolumab i.p. over 90 minutes on days 1, 15, and 29. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive nivolumab as in group I and ipilimumab i.p. on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of the study treatment, patients are followed up every 6 weeks for at least 100 days.
Tracking Information
- NCT #
- NCT03508570
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Amir A Jazaeri M.D. Anderson Cancer Center