Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-29 @ 1:26 AM
Study NCT ID:
NCT06238635
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2024-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dostarlimab and Cobolimab in Advanced Cervical Cancer
Sponsor:
Meghan Shea
Organization:
Study Overview
Official Title:
A Phase 2 Study of Dostarlimab in Combination With Cobolimab in Advanced Cervical Cancer
Status:
RECRUITING
Status Verified Date:
2025-10
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:
This research is being done to determine how effective dostarlimab in combination with cobolimab is in metastatic or recurrent cervical cancer.
Detailed Description:
This is a non-randomized, open-label, two-arm phase 2 trial of dostarlimab and cobolimab for participants with metastatic or recurrent cervical cancer who have or have not been treated with immunotherapy previously.
The names of the study drugs involved in this study are:
* Cobolimab (a type of monoclonal antibody)
* Dostarllimab (a type of monoclonal antibody)
The U.S. Food and Drug Administration (FDA) has not approved cobolimab as a treatment for cervical cancer.
The FDA has not approved dostarlimab for cervical cancer but it has been approved for other uses.
The study procedures including, screening for eligibility, treatment visits, blood tests, x-rays, Computerized Tomograph (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomograph (PET) scans.
Participants will be followed for up to 7 years.
It is expected that about 66 people will take part in this research study.
GlaxoSmithKline is funding this research study by providing funding and the study drugs.
The names of the study drugs involved in this study are:
* Cobolimab (a type of monoclonal antibody)
* Dostarllimab (a type of monoclonal antibody)
The U.S. Food and Drug Administration (FDA) has not approved cobolimab as a treatment for cervical cancer.
The FDA has not approved dostarlimab for cervical cancer but it has been approved for other uses.
The study procedures including, screening for eligibility, treatment visits, blood tests, x-rays, Computerized Tomograph (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomograph (PET) scans.
Participants will be followed for up to 7 years.
It is expected that about 66 people will take part in this research study.
GlaxoSmithKline is funding this research study by providing funding and the study drugs.
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?: