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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

Must not have

Received any prior treatment for management of their epithelial ovarian, fallopian tube, or peritoneal primary cancer

Synchronous primary endometrial cancer or past history of primary endometrial cancer not meeting specific conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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 suspected to have advanced ovarian, peritoneal, or fallopian tube cancer.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatment for ovarian, fallopian tube, or peritoneal cancer.

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I have or had endometrial cancer that doesn't meet certain conditions.

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I haven't had any other cancer besides this one in the last 3 years.

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My biopsy shows I don't have high grade serous cancer.

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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I have active cancer spread to my brain or its coverings.

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I have not had radiation in my abdomen, pelvis, or chest in the last 3 years.

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I am not expected to have surgery to reduce my tumor size.

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I refuse to receive blood transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5220

Cytoreductive surgery

2013

Completed Phase 3

~180