Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Linda R Duska
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Confirmed cervical cancer.

• Must have adequate organ function.

Exclusion Criteria:

• Subject is pregnant.

• Recurrent cervical cancer.

• Distant metastases.

• Malignancy within the last 5 years; basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy is permissable.

• Subject has had prior radiation, chemotherapy, targeted therapy, or investigational therapy for cervical cancer.

• Subject has a immunodeficiency.

• Known history of HIV, Hepatitis B, Hepatitis C, TB, or inflammatory bowel disease.

• Hypersensitivity to pembrolizumab or similar drugs.

• Subject has an active autoimmune disease in the past 2 years.

• Known history of non-infectious pneumonitis.

• Subject has an active infection.

• Subject has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases are permissible. Talk to Study Contact for specifics.