CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Ipilimumab +2 moredrug
Likely dose
Ipilimumab 1 mg/kgfrom 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/NCT04118166
NCT04118166Phase 2Completed
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Phase 2 Study of Ipilimumab Plus Nivolumab in Combination With Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma

Kristen Ganjoo·interventional·Posted Oct 8, 2019·Updated Dec 12, 2023

In Brief

A Phase 2 clinical trial evaluating Ipilimumab, Cryoablation, and 1 other intervention for Soft Tissue Sarcoma. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this Phase 2 study is to 1. find out if the study drugs (ipilimumab plus nivolumab) in combination with cryotherapy will help participants with metastatic or locally advanced soft tissue sarcoma;. 2. find out how safe are ipilimumab plus nivolumab given in combination with cryotherapy, and what side effects may be related to treatment. 3. find out how do the study drugs in combination with cryotherapy work in soft tissue sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Sarcoma
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 8, 2019
Enrollment StartOct 1, 2019
Primary CompletionJan 31, 2022
Study CompletionApr 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.7 years ago

Interventions

Ipilimumabdrug

Ipilimumab 1 mg/kg, injection

Cryoablationprocedure

Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures

Nivolumabdrug

Nivolumab 3 mg/kg, injection