Nivolumab +/- Ipilimumab for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDon Dizon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Don Dizon

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Preclinical and early-phase clinical data suggest that immune modulation represents a treatment strategy that is worthy of further investigation in relapsed epithelial ovarian cancer. One method by which tumor cells may evade immune surveillance is by activation of the programmed cell death (PD-1) pathway, mediated by expression of PD-1 on the surface of T lymphocytes, which conveys an inhibitory signal after binding to its ligand PD-L1 on the surface of tumor cells. Nivolumab and Ipilimumab have shown activity as monotherapies in solid tumors and very early data suggest that nivolumab may be particularly active for ovarian clear cell carcinoma.(Hamanishi et al., 2015). Given the uniformly poor prognosis for patients with clear cell carcinoma in general, we are interested in formally evaluating this agent in all extra-renal clear cell carcinomas.

Eligibility Criteria

This trial is for adults with clear cell carcinoma of ovarian, fallopian tube, primary peritoneal, or extra-renal origin who have progressed after prior treatments. They must have good organ function and performance status, no history of certain immune diseases or severe allergies to monoclonal antibodies, not be pregnant or breastfeeding, and agree to use effective contraception.

Inclusion Criteria

My ovarian, fallopian, or peritoneal cancer worsened after platinum and taxane treatment.

My clear cell cancer has worsened after at least one treatment for its advanced stage.

leukocytes ≥3,000/mcL

+23 more

Exclusion Criteria

You have had a serious allergic reaction to any type of medication called monoclonal antibodies.

I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.

I have previously received treatments targeting the immune system for cancer.

+14 more

Participant Groups

The study is testing the effectiveness of Nivolumab alone or in combination with Ipilimumab in treating clear cell carcinomas. These drugs are designed to help the immune system recognize and attack cancer cells by blocking pathways that cancer uses to hide from immune cells.

4Treatment groups

Experimental Treatment

Group I: Arm 2 Nivolumab and Ipilimumab OvarianExperimental Treatment2 Interventions

Nivolumab 240 mg every 2 weeks Ipilimumab 1mg/kg day 1 Cycle=6 weeks

Group II: Arm 2 Nivolumab and Ipilimumab Extra-renalExperimental Treatment2 Interventions

Nivolumab 240 mg every 2 weeks Ipilimumab 1mg/kg day 1 Cycle=6 weeks

Group III: Arm 1 Nivolumab OvarianExperimental Treatment1 Intervention

Nivolumab 240 mg Day 1 Cycle = 2 weeks

Group IV: Arm 1 Nivolumab Extra-renalExperimental Treatment1 Intervention

Nivolumab 240 mg Day 1 Cycle = 2 weeks

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: