Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT04118166
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2019-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ipilimumab + Nivolumab + Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma
Sponsor:
Kristen Ganjoo
Organization:
Study Overview
Official Title:
Phase 2 Study of Ipilimumab Plus Nivolumab in Combination With Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SARCOMA0038 | OTHER | OnCore | View |