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

Part of paid clinical trials in Stanford, California.

Sponsor
Kristen Ganjoo
Study ID
NCT04118166
Phase
PHASE2
Status
Completed

Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2019
Status verified
Nov 2023
Primary completion
Jan 31, 2022
Completion
Apr 26, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab/nivolumab + cryotherapy
    1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2

Primary Outcome Measure

Clinical Response [ Time Frame: 14 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Medical CenterStanfordCalifornia94304-

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By research site
Stanford Medical Center· Stanford, CA

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