NCT04118166

Ipilimumab + Nivolumab + Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma

Phase 2 Study of Ipilimumab Plus Nivolumab in Combination With Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Kristen Ganjoo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: 1\) Assess whether the rate of clinical benefit is sufficiently high to merit promise for further study Secondary Objectives: 1. Characterize the 6-month progression-free survival rate 2. Assess whether the treatment yields a reasonably safe and tolerable profile

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab 1 mg/kg, injection
PROCEDURE	Cryoablation	Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
DRUG	Nivolumab	Nivolumab 3 mg/kg, injection

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-01-31
• Completion: 2022-04-26
• First posted: 2019-10-08
• Last updated: 2023-12-12
• Results posted: 2022-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study