Trials / Active Not Recruiting
Active Not RecruitingNCT06238635
Dostarlimab and Cobolimab in Advanced Cervical Cancer
A Phase 2 Study of Dostarlimab in Combination With Cobolimab in Advanced Cervical Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Meghan Shea · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cervical Cancer
- Advanced Cervical Carcinoma
- Metastatic Cervical Cancer
- Metastatic Cervical Carcinoma
- Recurrent Cervical Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dostarlimab | Humanized monoclonal antibody, 50mg/mL type 1 borosilicate clear glass vial, via intravenous infusion per protocol. |
| DRUG | Cobolimab | Humanized anti-TIM-3 monoclonal antibody, 20mg/mL single-use vial, via intravenous infusion per protocol. |
Timeline
- Start date
- 2024-03-11
- Primary completion
- 2026-12-01
- Completion
- 2027-07-15
- First posted
- 2024-02-02
- Last updated
- 2026-01-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06238635. Inclusion in this directory is not an endorsement.