Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779423
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-03-09
Brief Title:
CryoablationIpilimumabNivolumab in Melanoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of Core Needle Biopsy and Cryoablation of an Enlarging Tumor in Patients With Advanced Melanoma Receiving Post-progression Dual Immune Checkpoint Inhibitor Therapy
Status:
RECRUITING
Status Verified Date:
2024-03
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 aim of this study is to find out whether the combination of two approved drugs ipilimumab and nivolumab in combination with cryoablation are safe and effective for participants who have an unresectable melanoma that is resistant or is growing after receiving immunotherapy with a PD-1 inhibitor
The names of the study interventions involved in this study are
Cryoablation an interventional radiology procedure that freezes part of a tumor
Ipilimumab an immunotherapy
Nivolumab an immunotherapy
The names of the study interventions involved in this study are
Cryoablation an interventional radiology procedure that freezes part of a tumor
Ipilimumab an immunotherapy
Nivolumab an immunotherapy
Detailed Description:
This is a single-arm two-stage Phase II clinical trial to test the safety and effectiveness of an investigational treatment the combination of ipilimumab and nivolumab with cryoablation for the treatment of metastatic melanoma resistant to PD-1 inhibition
Ipilimumab and nivolumab are types of inhibitors Ipilimumab targets and blocks specific proteins in cancer cells which are responsible for stopping the immune system from working correctly Nivolumab targets a receptor on cancer cells that causes programmed cell death
The US Food and Drug Administration has approved Ipilimumab and Nivolumab for the treatment of melanoma
Cryoablation is an approved procedure that consists of freezing a tumor and surgically removing it The use of the study drugs and cryoablation combination is experimental
Study procedures including screening for eligibility study treatment including in-clinic visits blood sample collections Computerized Tomography CT scans and tumor biopsies
Participation in this research study is expected to last up to 3 years
It is expected that about 37 people will take part in this research study
The William M Wood Foundation is supporting this research by providing funding for the cryoablation and research activities
Ipilimumab and nivolumab are types of inhibitors Ipilimumab targets and blocks specific proteins in cancer cells which are responsible for stopping the immune system from working correctly Nivolumab targets a receptor on cancer cells that causes programmed cell death
The US Food and Drug Administration has approved Ipilimumab and Nivolumab for the treatment of melanoma
Cryoablation is an approved procedure that consists of freezing a tumor and surgically removing it The use of the study drugs and cryoablation combination is experimental
Study procedures including screening for eligibility study treatment including in-clinic visits blood sample collections Computerized Tomography CT scans and tumor biopsies
Participation in this research study is expected to last up to 3 years
It is expected that about 37 people will take part in this research study
The William M Wood Foundation is supporting this research by providing funding for the cryoablation and research activities
Study Oversight
Has Oversight DMC:
None
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?:
None