Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute LAO
Study ID
NCT05836571
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Locally Advanced Extraskeletal Myxoid Chondrosarcoma
  • Locally Advanced Leiomyosarcoma
  • Locally Advanced Liposarcoma
  • Locally Advanced Undifferentiated Pleomorphic Sarcoma
  • Locally Advanced Unresectable Soft Tissue Sarcoma
  • Metastatic Soft Tissue Sarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Unresectable Leiomyosarcoma
  • Unresectable Liposarcoma
  • Unresectable Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of urine and/or blood sample
  • Cabozantinib — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial compares the effect of immunotherapy with ipilimumab and nivolumab alone to their combination with cabozantinib in treating patients with soft tissue sarcoma that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Adding cabozantinib to the combination of ipilimumab and nivolumab may be better in stopping or slowing the growth of tumor compared to ipilimumab and nivolumab alone in patients with advanced soft tissue sarcoma.

Key Dates

Start date
Oct 25, 2023
Status verified
Apr 2026
Primary completion
May 15, 2026
Completion
May 15, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (nivolumab, ipilimumab)
    Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 60-90 minutes on day 1 of each cycle. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for 4 cycles. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans, tumor biopsies, and collection of urine samples throughout the trial. Patients may also optionally undergo collection of blood samples at baseline. Patients can crossover from Arm A to Arm B at the time of disease progression.
  • Experimental: Arm B (cabozantinib, nivolumab, ipilimumab)
    See Detailed Description.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 30 days after completion of study treatment ]

Locations (26)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
Keck Medicine of USC KoreatownLos AngelesCalifornia90020-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Smilow Cancer Hospital Care Center at Saint FrancisHartfordConnecticut06105-
Yale UniversityNew HavenConnecticut06520-
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610-
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAKeck Medicine of USC Koreatown· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology/Hematology-Newport Beach· Newport Beach, CA

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