CompletedPhase 1

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

United States27 participantsStarted 2017-08-04

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception.
✕. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mL.

What they're measuring

number of patients with dose limiting toxicities with weekly paclitaxel/carboplatin plus nivolumab

Timeframe: 6 weeks

number of patients with dose limiting toxicities weekly paclitaxel/carboplatin plus nivolumab and ipilimumab

Timeframe: 6 weeks

Trial details

NCT IDNCT03245892

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-04

View on ClinicalTrials.gov More High Grade Serous Ovarian trials