CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 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/NCT02304458
NCT02304458Phase 2Completed

A Phase 1/2 Study of Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors as a Single Agent and in Combination With Ipilimumab

National Cancer Institute (NCI)·interventional·Posted Dec 2, 2014·Updated Oct 17, 2023

In Brief

A Phase 2 clinical trial evaluating Ipilimumab, Laboratory Biomarker Analysis, and 2 other interventions for Metastatic Melanoma and 22 related conditions. Completed, enrolled 140 participants across 25 sites in 2 countries.

Detailed Summary

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.

Study Details

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2, 2014
Enrollment StartMar 30, 2015
Primary CompletionSep 30, 2021
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.6 years ago

Interventions

Ipilimumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Nivolumabbiological

Given IV

Pharmacological Studyother

Correlative studies