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Alkylating agents

Chemotherapy + Immunotherapy for Ovarian Cancer

Phase 1
Waitlist Available
Led By Claire Friedman
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Age ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will test the effectiveness of adding nivolumab or a combination of nivolumab and ipilimumab to the standard chemotherapy treatment of Carboplatin and Paclitaxel for advanced high-grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin.

Who is the study for?
This trial is for adults with advanced high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. Participants must be in good physical condition (ECOG Status of 0-2), have not received prior treatment for their cancer, and have adequate organ function. They cannot join if they've had other cancers within the last 3 years, previous radiotherapy to the abdomen/pelvis/thorax, active autoimmune diseases, or are pregnant/nursing.Check my eligibility
What is being tested?
The study tests adding Nivolumab alone or combined with Ipilimumab to standard chemotherapy (Carboplatin and Paclitaxel) before surgery in treating these cancers. It aims to see whether this combination improves outcomes compared to chemotherapy alone.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the liver or lungs, infusion reactions from the drugs being administered into a vein, fatigue from treatment exhaustion, blood cell count changes increasing infection risk and bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced ovarian, peritoneal, or fallopian tube cancer and will receive chemotherapy before surgery.
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I am 18 years old or older.
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I am 18 years old or older.
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I've had a CT or MRI scan within the last 28 days showing advanced stage cancer.
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My biopsy was confirmed at MSKCC or I'm willing to have another if it wasn't.
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I am suspected to have advanced ovarian, peritoneal, or fallopian tube cancer.
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My white blood cell count is healthy without medication.
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My hemoglobin level is at least 8.0 mg/dl, possibly with help from transfusions.
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I've been mostly active in the last month.
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My recent scans show my cancer is at an advanced stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of patients with dose limiting toxicities weekly paclitaxel/carboplatin plus nivolumab and ipilimumab
number of patients with dose limiting toxicities with weekly paclitaxel/carboplatin plus nivolumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nivolumab plus Ipilimumab plus Paclitaxel & CarboplatinExperimental Treatment4 Interventions
Patients will be treated with nivolumab plus ipilimumab plus standard of care dose dense paclitaxel & carboplatin chemotherapy for 3 cycles (up to a maximum of six), each cycle is 3 weeks, followed by cytoreductive surgery then three more cycles of the same treatment regimen. Paclitaxel 80mg/m2 IV will be administered over approx 1 hour on Days 1,8, & 15 of each 21 day cycle. Carboplatin AUC6 will be administered as an approx 30 minute IV infusion, following paclitaxel admin on Day 1 of each 21 day cycle. Nivolumab 360mg will be infused IV over approx 30 min on Day 1 of Cycles 1-6 (to 9) of each 21 day cycle. Ipilimumab 1mg/kg will be infused IV over approx 30 min on Day 1 of Cycles 1 & 3, as well as Cycle 4 & Cycle 6. Of note, if patients receive more than 3 cycles in the pre-operative setting, then ipilimumab will be administered with the first & third cycle in the post-operative setting. Nivolumab will then be infused Day 1 of each 28 day maintenance phase cycle.
Group II: Carboplatin and Paclitaxel Chemotherapy With Nivolumab (Closed)Experimental Treatment3 Interventions
Patients will be treated with nivolumab plus standard of care dose dense paclitaxel and carboplatin for three cycles, where each cycle is 3 weeks, followed by cytoreductive surgery then three more cycles of the same treatment regimen administered as adjuvant treatment. Paclitaxel 80mg/m2 will be administered over approximately 1 hour as an IV infusion on Days 1,8, and 15 of each 21-day cycle. Carboplatin AUC6 will be administered as approximately a 30 minute IV infusion, following paclitaxel administration on Day 1 of each 21-day cycle. Carboplatin dose calculation instructions can be found in Appendix 4. Nivolumab 360mg will be infused IV over approximately 30min on Day 1 of Cycles 1-6. During the maintenance phase, Nivolumab 480mg will be infused IV on day 1 of each 28 day cycle, for up to 12 months. During the maintenance period, each cycle is 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2640
Cytoreductive surgery
2013
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,768 Total Patients Enrolled
73 Trials studying Ovarian Cancer
56,895 Patients Enrolled for Ovarian Cancer
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,207 Total Patients Enrolled
12 Trials studying Ovarian Cancer
1,217 Patients Enrolled for Ovarian Cancer
Claire FriedmanPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration given its stamp of approval to Carboplatin and Paclitaxel?

"As a Phase 1 clinical trial, the safety of carboplatin and paclitaxel has been limitedly studied. Our team at Power assigned it a score of 1 on our assessment scale."

Answered by AI

For what therapeutic purposes is Carboplatin and Paclitaxel commonly prescribed?

"Carboplatin and Paclitaxel can be used to treat menacing neoplasms, incurable melanoma, and squamous cell carcinomas."

Answered by AI

How many patients have enrolled in this experiment?

"This trial is no longer open for recruitment. It was first posted on August 4th 2017 and its last update took place April 13th 2022. Currently, 131 studies are looking to enrol patients with Fallopian tubes issues while 1,872 trials require participants for Carboplatin/Paclitaxel treatments ."

Answered by AI

Are there vacancies for individuals to join this scientific experiment?

"This study, which went live on 8/4/2017 and was last updated on 4/13/2022, is not presently recruiting any additional participants. Nevertheless, there are over two thousand other medical trials currently in the process of enrolment."

Answered by AI
~7 spots leftby Aug 2025