Clinical Trials Logo

Clinical Trial Summary

This phase I/II trial studies how well pembrolizumab and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and carboplatin with platinum resistant chemotherapy may work better than platinum chemotherapy alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the clinical response rate of platinum chemotherapy and pembrolizumab (MK-3475) in platinum chemotherapy pretreated ovarian, fallopian tube, and primary peritoneal. II. To examine whether retreatment with platinum chemotherapy in platinum resistant ovarian, fallopian tube, and primary peritoneal cancers improves progression free survival by concurrent administration of MK-3475. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of concurrent administration of MK-3475 with platinum chemotherapy in patients with platinum resistant recurrent ovarian, fallopian tube, and primary peritoneal cancers. II. To determine the relationship between PD-L1 expression and response to the combination of MK-3475 and platinum. III. To assess the overall survival of patients treated with the combination of MK-3475 and platinum. EXPLORATORY OBJECTIVE: I. To explore whether treatment with MK-3475 and platinum alters soluble factors in sera, peripheral immune responses and immune cell profile. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, every 6 months for 1 year, and then every 12 weeks thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03029598
Study type Interventional
Source University of Washington
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 14, 2017
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT01010126 - Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer Phase 2
Recruiting NCT05920798 - A Study of FRaDCs for Ovarian Cancer Phase 1/Phase 2
Recruiting NCT03968406 - Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers Phase 1
Active, not recruiting NCT03508570 - Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis Phase 1
Completed NCT00301756 - Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors Phase 2
Completed NCT00066456 - Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00045682 - CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Phase 2
Active, not recruiting NCT03353831 - Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer Phase 3
Active, not recruiting NCT04781088 - Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 2
Completed NCT02853318 - Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 2
Active, not recruiting NCT03325634 - Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer Phase 1
Completed NCT01039207 - Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Phase 2
Withdrawn NCT00551265 - Oregovomab With or Without Cyclophosphamide in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Responded to Second-Line Chemotherapy N/A
Completed NCT00093626 - Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer Phase 2
Terminated NCT02569957 - Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 2
Recruiting NCT04469764 - Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer Phase 2
Active, not recruiting NCT01081262 - Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer Phase 3
Active, not recruiting NCT04019288 - AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 1/Phase 2
Completed NCT01459380 - Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Phase 1
Terminated NCT03924245 - Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers Phase 1