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Dostarlimab and Cobolimab in Advanced Cervical Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Dostarlimab and Cobolimab in Advanced Cervical Cancer

A Phase 2 Study of Dostarlimab in Combination With Cobolimab in Advanced Cervical Cancer

NCT06238635•Meghan Shea

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically or cytologically confirmed cervical carcinoma, all histologies included.
•All patients must have measurable disease as defined by RECIST 1.1. as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>10 mm when measured by CT, MRI or caliper measurement by clinical exam; or \>20 mm when measured by chest x-ray. Lymph nodes must be \>15 mm in the short axis when measured by CT or MRI. Radiological evaluation should occur within 30 days prior to enrollment initiation.
•Age of 18 or greater years. Because insufficient dosing or adverse event data are available on the use of dostarlimab or cobolimab in participants \<18 years of age, children are excluded from the study. Cervical cancer is rare in the pediatric population.
•ECOG performance status 0, 1, or 2.
•Availability of at least two formalin fixed paraffin embedded (FFPE) blocks of cancer tissue OR at least 1 FFPE block AND at least 3 unstained 5-micron slides, OR at least 1 unstained 5-micron slides from original surgery or biopsy or from a biopsy of recurrent disease.
•Participants must have adequate organ and marrow function as defined below:
•* absolute neutrophil count ≥1,500/mcL
•* platelets ≥100,000/mcL
•* hemoglobin ≥ 9 g/dL
•* total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin ≤ 1.0 x ULN
+39 more criteria

Exclusion Criteria

•Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication.
•Participants who are receiving any other investigational agents.
•Patient has known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable, have no evidence of new or enlarging brain metastases on repeat imaging at least 4 weeks after treatment, and are off steroids 3 days prior to dosing with study treatment. Stable brain metastases by this definition should be established prior to the first dose of study treatment.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to dostarlimab or cobolimab. Known severe hypersensitivity reactions to monoclonal antibodies (Grade \>=3, NCI CTCAE 5.0).
•Participants with a history of treatment anti-CTLA4, TIM3 antagonist, or other investigational agents that target immune checkpoint inhibitors
•Participants who had prior anti-PD-1 or anti-PD-L1 therapy
•History of interstitial lung disease
•Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
•Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication.
•Participants who are receiving any other investigational agents.
+7 more criteria

Locations (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

March 11, 2024

Primary Completion Date

December 1, 2026

Completion Date

July 15, 2027

Last Updated

January 13, 2026

Enrollment

ESTIMATED participants

Conditions

Cervical CancerAdvanced Cervical CarcinomaMetastatic Cervical CancerMetastatic Cervical CarcinomaRecurrent Cervical Carcinoma

Interventions

Dostarlimab

DRUG

Cobolimab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dostarlimab and Cobolimab in Advanced Cervical Cancer

Inclusion Criteria

Exclusion Criteria

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

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