Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02304458
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Melanoma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Hodgkin Lymphoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Melanoma
  • Recurrent Neuroblastoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Osteosarcoma
  • Recurrent Rhabdomyosarcoma
  • Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Refractory Hodgkin Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Melanoma
  • Refractory Neuroblastoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Osteosarcoma
  • Refractory Rhabdomyosarcoma
  • Stage III Cutaneous Melanoma AJCC v7
  • Stage IIIA Cutaneous Melanoma AJCC v7
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
12 Months - 30 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better alone or with ipilimumab in treating patients with recurrent or refractory solid tumors or sarcomas.

Key Dates

Start date
Mar 30, 2015
Status verified
Sep 2023
Primary completion
Sep 30, 2021
Completion
Mar 31, 2023

Study Design

Enrollment
140 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, ipilimumab)
    See Detailed Description

Primary Outcome Measure

Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab [ Time Frame: 28 days ]

Locations (24)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital of Orange CountyOrangeCalifornia92868-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Healthcare of Atlanta - EglestonAtlantaGeorgia30322-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
Riley Hospital for ChildrenIndianapolisIndiana46202-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
C S Mott Children's HospitalAnn ArborMichigan48109-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Oregon Health and Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Saint Jude Children's Research HospitalMemphisTennessee38105-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-
Children's Hospital of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Children's Hospital of Alabama· Birmingham, ALChildren's Hospital Los Angeles· Los Angeles, CAChildren's Hospital of Orange County· Orange, CALucile Packard Children's Hospital Stanford University· Palo Alto, CAUCSF Medical Center-Mission Bay· San Francisco, CAChildren's Hospital Colorado· Aurora, CO

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