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Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer

Phase 2

Waitlist Available

Led By Linda Duska, MD

Research Sponsored by Linda R Duska

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 weeks of chemoradiation and 12 weeks post-chemoradiation

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

The purpose of this study is to evaluate the safety and effectiveness of immunotherapy in combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced cervical cancer. Pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will be administered after or during chemoradiation.

Eligible Conditions

Cervical Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 weeks of chemoradiation and 12 weeks post-chemoradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 weeks of chemoradiation and 12 weeks post-chemoradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks of chemoradiation and 12 weeks post-chemoradiation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in immunologic markers following combination of study drug with chemoradiation

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: Following chemoradiationExperimental Treatment3 Interventions

Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.

Group II: Concurrent to chemoradiationExperimental Treatment3 Interventions

Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

Pembrolizumab

FDA approved

Brachytherapy

2007

Completed Phase 3

~2140