Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02428192
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Leiomyosarcoma
  • Unresectable Leiomyosarcoma
  • Uterine Corpus Leiomyosarcoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
May 19, 2015
Status verified
Feb 2025
Primary completion
Sep 20, 2018
Completion
Jan 28, 2021

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (nivolumab - closed to accrual on 21-Oct-2015)
    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.
  • Experimental: Cohort B (nivolumab and Ipilimumab)
    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.

Primary Outcome Measure

Objective Response Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Among Patients With Advanced Leiomyosarcoma of the Uterus (ULMS) Treated With Nivolumab (Cohort A) [ Time Frame: Up to 100 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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