Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03508570
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Peritoneal Neoplasm
  • Malignant Retroperitoneal Neoplasm
  • Metastatic Cervical Carcinoma
  • Metastatic Endometrial Carcinoma
  • Metastatic Fallopian Tube Carcinoma
  • Metastatic Malignant Female Reproductive System Neoplasm
  • Metastatic Ovarian Carcinoma
  • Metastatic Primary Peritoneal Carcinoma
  • Peritoneal Carcinomatosis
  • Platinum-Refractory Fallopian Tube Carcinoma
  • Platinum-Refractory Malignant Female Reproductive System Neoplasm
  • Platinum-Refractory Ovarian Carcinoma
  • Platinum-Refractory Primary Peritoneal Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Malignant Female Reproductive System Neoplasm
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Cervical Carcinoma
  • Recurrent Endometrial Carcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Malignant Female Reproductive System Neoplasm
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Stage IVA Fallopian Tube Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVA Primary Peritoneal Cancer AJCC v8
  • Stage IVB Cervical Cancer AJCC v8
  • Stage IVB Fallopian Tube Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Stage IVB Primary Peritoneal Cancer AJCC v8
  • Stage IVB Uterine Corpus Cancer AJCC v8

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given i.p.
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given i.p.
  • Pharmacokinetic Study — OTHER
    Correlative studies

Study Details

This phase Ib trial studies the side effects and best dose of nivolumab with or without ipilimumab in treating patients with female reproductive cancer that has come back (recurrent) or is high grade and has spread extensively throughout the peritoneal cavity (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Sep 21, 2018
Status verified
May 2025
Primary completion
Nov 11, 2024
Completion
Nov 11, 2024

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (nivolumab)
    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.
  • Experimental: Group II (nivolumab and ipilimumab)
    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.

Primary Outcome Measure

Maximum tolerated dose (MTD)/recommended phase II dose (RP2D) of intraperitoneal (i.p.) nivolumab in combination with ipilimumab [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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