Nivolumab + Ipilimumab for Uterine Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Active autoimmune disease, Brain metastasis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 92 weeks for Cohort A, 12 weeks for Cohort B

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well nivolumab alone or in combination with ipilimumab works in treating patients with uterine cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

Research Team

Suzanne George

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

This trial is for patients with advanced uterine leiomyosarcoma, a type of cancer that has spread and is typically incurable. Participants must have had at least one prior chemotherapy treatment, be in good physical condition (ECOG 0 or 1), and not be pregnant or breastfeeding. They should not have active brain metastases, severe allergies to monoclonal antibodies, HIV/AIDS, hepatitis B/C infection, uncontrolled illnesses, or a history of certain autoimmune diseases.

Inclusion Criteria

Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)

Platelets >= 100,000/mcL

My cancer is a type of uterine cancer that has spread or cannot be surgically removed.

Exclusion Criteria

Patients who are receiving any other investigational agents

History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab

History of severe hypersensitivity reaction to any monoclonal antibody

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nivolumab alone or in combination with ipilimumab. Cohort A receives nivolumab every 2 weeks for up to 46 doses. Cohort B receives nivolumab and ipilimumab every 21 days for up to 4 courses.

Up to 92 weeks for Cohort A, 12 weeks for Cohort B

Follow-up

Participants are monitored for safety and effectiveness after treatment

100 days

Treatment Details

Interventions

• Ipilimumab
• Nivolumab

Trial Overview The study tests the effectiveness of Nivolumab alone or combined with Ipilimumab—both are monoclonal antibodies—in treating advanced uterine leiomyosarcoma. The trial aims to see how these treatments affect tumor growth and spread by targeting specific pathways within the body's immune system.

Participant Groups

Group I: Cohort B (nivolumab and Ipilimumab) Experimental Treatment 2 Interventions

Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Cohort A (nivolumab - closed to accrual on 21-Oct-2015) Experimental Treatment 2 Interventions

Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity.

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

Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+