MedTrace Logo

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery

NCT02500797 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-10-17

Study results available
· View outcomes & findings →

Summary

This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). 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 with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.

Conditions

  • Locally Advanced Bone Sarcoma
  • Locally Advanced Dedifferentiated Liposarcoma
  • Locally Advanced Gastrointestinal Stromal Tumor
  • Locally Advanced Soft Tissue Sarcoma
  • Metastatic Bone Sarcoma
  • Metastatic Liposarcoma
  • Metastatic Soft Tissue Sarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Metastatic Unresectable Sarcoma
  • Pleomorphic Liposarcoma
  • Stage III Bone Sarcoma AJCC v7
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Stage IV Bone Sarcoma AJCC v7
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Stage IVA Bone Sarcoma AJCC v7
  • Stage IVB Bone Sarcoma AJCC v7
  • Unresectable Bone Sarcoma
  • Unresectable Dedifferentiated Liposarcoma
  • Unresectable Liposarcoma
  • Unresectable Malignant Gastrointestinal Stromal Tumor
  • Unresectable Soft Tissue Sarcoma

Interventions

BIOLOGICAL

Ipilimumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Nivolumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Sandra P D'Angelo · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-13
Primary Completion
2019-04-01
Completion
2023-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500797 on ClinicalTrials.gov