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Monoclonal Antibodies

Dostarlimab + Cobolimab for Cervical Cancer

Phase 2

Recruiting

Led By Meghan Shea, MD

Research Sponsored by Meghan Shea

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 18 or greater years

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured

Must not have

Individuals with a history of a different malignancy are ineligible

History of interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well a combination of dostarlimab and cobolimab works in treating advanced cervical cancer that has spread or come back.

Who is the study for?

This trial is for adults with measurable, recurrent or metastatic cervical cancer. They must have good organ function and performance status, no severe prior treatment side effects, and not be pregnant or breastfeeding. Those previously treated for hepatitis C can join if cured. Exclusions include past immune checkpoint inhibitor therapy, recent chemo or radiotherapy, active autoimmune diseases, HIV/AIDS, current serious illnesses, use of immunosuppressants or live vaccines recently.

What is being tested?

The study tests the effectiveness of combining two drugs: Dostarlimab and Cobolimab in treating advanced cervical cancer that has spread (metastatic) or returned after treatment (recurrent). The goal is to see how well these drugs work together against this type of cancer.

What are the potential side effects?

Potential side effects may include allergic reactions similar to those from compounds related to Dostarlimab and Cobolimab. There's also a risk of worsening autoimmune disease symptoms due to the immune-stimulating nature of the treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I had hepatitis C but have been treated and cured.

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Side effects from my previous treatments are mild or gone.

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My cervical cancer diagnosis was confirmed through lab tests.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had any type of cancer other than my current diagnosis.

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I have a history of lung scarring or fibrosis.

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I have an autoimmune disease that could worsen with immune-stimulating treatments.

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I have been diagnosed with HIV/AIDS.

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I need hormone replacement therapy with corticosteroids.

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I have cancer that has spread to my brain or surrounding membranes.

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I have been treated with drugs targeting the immune system for cancer.

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I have previously received anti-PD-1 or anti-PD-L1 therapy.

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I have active hepatitis B, C, or cirrhosis.

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I do not have any uncontrolled illnesses.

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I have severe stomach or intestinal problems.

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I have had an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) Based on irRECIST

Secondary study objectives

Grade 3-5 Adverse Events Rate

Immune-Related (PFS) Progression-Free Survival

Median Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: Immunotherapy ExposedExperimental Treatment2 Interventions

14 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day of 21 Day cycle: Predetermined dose of Dostarlimab 1x daily. Predetermined dose of Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 23 additional participants will be enrolled.

Group II: Cohort A: Immunotherapy NaiveExperimental Treatment2 Interventions

10 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day 1 of 21 Day cycle: Dostarlimab 1x daily and Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 19 additional participants will be enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cobolimab

2016

Completed Phase 3

~1590

Dostarlimab

2020

Completed Phase 3

~1760