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

NCT04118166 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-12

Study results available
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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.

Conditions

  • Soft Tissue Sarcoma

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kristen Ganjoo, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-01-31
Completion
2022-04-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT04118166 on ClinicalTrials.gov