Nivolumab + Ipilimumab for Uterine Cancer
Recruiting at 1 trial location
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
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
SG
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.
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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
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Treatment Details
Interventions
- Ipilimumab
- Nivolumab
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: Cohort B (nivolumab and Ipilimumab)Experimental Treatment2 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 Treatment2 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
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
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Recruited
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