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A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer

A Pilot Study of Nivolumab With or Without Ipilimumab in Combination With Front-Line Neoadjuvant Dose Dense Paclitaxel and Carboplatin Chemotherapy and Post-Surgical Dose Dense Paclitaxel and Carboplatin Chemotherapy in Patients With High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT03245892•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out what effects, good or bad, the addition of nivolumab or the combination of nivolumab plus ipilimumab to typical chemotherapy has on the treatment of advanced high-grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin. The typical chemotherapy treatment is Carboplatin and Paclitaxel.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients must have clinically and radiographically suspected International Federation of Gynecology and Obstetrics (FIGO) stage (Appendix 2) 3 or 4 high grade serous ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS). Patients will be selected for NACT according to established criteria (Society of Gynecologic Oncology and the American Society of Clinical Oncology Guideline, https://www.ncbi.nlm.nih.gov/pubmed/27650684). Patients must have undergone core needle biopsy for histologic confirmation prior to start of treatment. See Appendix 3 for guidelines to aid in histologic diagnosis.
•Institutional confirmation of pathology on or laparoscopic biopsy performed at MSKCC with sufficient tissue for analysis or willingness to undergo repeat laproscopic biopsy if diagnostic biopsy was performed at an outside hospital.
•Appropriate stage for study entry based on the following diagnostic workup:
•* History/physical examination within 28 days prior to registration;
•* CT imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease (patients who cannot receive contrast may instead undergo MRI of abdomen and pelvis along with non-contrast chest CT);
•* Further protocol-specific assessments as detailed below.
•Age ≥18
•ECOG Status of 0, 1, or 2 within 28 days prior to registration.
•Adequate hematologic function within 14 days prior to registration defined as follows:
•* ANC ≥1,000/mcl. This ANC cannot have been induced by granulocyte colony stimulating factors.
+17 more criteria

Exclusion Criteria

•Subjects with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 3 years. Subjects are also excluded if their previous cancer treatment contraindicates this protocol's therapy.
•Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded. Prior radiation for localized cancer of the breast, head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
•Patients who have received any prior treatment for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer.
•Patients with any histology other than high grade serous evident on pretreatment biopsy.
•Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: Stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions.
•Severe, active co-morbidity defined as follows:
•Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment (with the exception of uncomplicated UTI)
•Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association Class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate).
•Partial or complete gastrointestinal obstruction
•Patients with anticipated contraindications to interval tumor reductive surgery.
+8 more criteria

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

August 4, 2017

Primary Completion Date

December 4, 2025

Completion Date

December 4, 2025

Last Updated

December 17, 2025

Enrollment

ACTUAL participants

Conditions

High Grade Serous OvarianFallopian TubePrimary Peritoneal Cancer

Interventions

Carboplatin and Paclitaxel

DRUG

Nivolumab

DRUG

Cytoreductive surgery

PROCEDURE

Ipilimumab

DRUG

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

View study

RECRUITINGPHASE3

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

NCT05281471

Platinum-resistant Ovarian CancerPlatinum-refractory Ovarian Cancer+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

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Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab