CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 164 enrolled
Drug / intervention
Ipilimumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02500797
NCT02500797Phase 2Completed

Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Patients With Metastatic or Unresectable Sarcoma

National Cancer Institute (NCI)·interventional·Posted Jul 17, 2015·Updated Oct 17, 2023

In Brief

A Phase 2 clinical trial evaluating Ipilimumab, Laboratory Biomarker Analysis, and 2 other interventions for Locally Advanced Bone Sarcoma and 20 related conditions. Completed, enrolled 164 participants across 651 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 17, 2015
Enrollment StartAug 13, 2015
Primary CompletionApr 1, 2019
Study CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.0 years ago

Interventions

Ipilimumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Nivolumabbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies