Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
NCT03508570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-05-22
Summary
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.
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
Interventions
- BIOLOGICAL
-
Given i.p.
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Given i.p.
- OTHER
-
Pharmacokinetic Study
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Amir A Jazaeri · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-21
- Primary Completion
- 2024-11-11
- Completion
- 2024-11-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
NCT00019552 ·Status: COMPLETED ·Phase: PHASE2
-
Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
NCT04034927 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer
NCT05276973 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT03586661 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer
NCT05185947 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase I Study of WT1 or NY-ESO-1 Vaccine and Nivolumab For Recurrent Ovarian Cancer
NCT02737787 ·Status: COMPLETED ·Phase: PHASE1
-
Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer
NCT01116648 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Nivolumab in Selected Uterine Cancer Patients
NCT03241745 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer
NCT05231122 ·Status: RECRUITING ·Phase: PHASE2
-
Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
NCT00501644 ·Status: COMPLETED ·Phase: PHASE2
-
Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma
NCT04149275 ·Status: WITHDRAWN ·Phase: PHASE2
-
Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT00886691 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer
NCT05028504 ·Status: RECRUITING ·Phase: PHASE2
-
Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT02627443 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Tolerance of Intraperitoneal (IP) Nivolumab After Extensive Debulking Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Ovarian Carcinoma
NCT03959761 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pembrolizumab and Carboplatin for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT04387227 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
NCT03914612 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer
NCT04214067 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT00951496 ·Status: COMPLETED ·Phase: PHASE3
-
Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer
NCT03704467 ·Status: COMPLETED ·Phase: PHASE1
-
RO4929097 in Treating Patients With Recurrent and/or Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT01175343 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
NCT03635567 ·Status: COMPLETED ·Phase: PHASE3
-
Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
NCT01468909 ·Status: COMPLETED ·Phase: PHASE2
-
Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
NCT00095979 ·Status: COMPLETED ·Phase: PHASE2
-
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
NCT00126542 ·Status: COMPLETED ·Phase: PHASE2