NCT02635360

Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer

A Randomized Phase II Study of Chemoradiation and Pembrolizumab for Locally Advanced Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Linda R Duska · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary: (1) To estimate the immunologic effects, as assessed in the tumor \& PBMC, of both sequential and concurrent administration of pembrolizumab to CRT. Change between pre and post measurements of HPV E2, E7 specific CD8+ T cells, regulatory FoxP3+ T cells (Tregs) and the ratio of CD8+ T cells to Tregs are the immune measurements of primary interest. (2) To determine the safety of concurrent chemoradiation in combination with pembrolizumab for the treatment of locally advanced cervical cancer. Secondary: (1) To estimate rates of complete metabolic response on PET/CT imaging obtained 12 weeks after CRT. (2) To estimate rates of distant metastasis as the first site of recurrence for patients. (3) To estimate the influence of concurrent and consolidative MK-3475 on levels of plasminogen activator inhibitor-1 (PAI-1), a marker of immunosuppressive TGF-B. (4) To estimate the influence of concurrent and consolidative MK-3475 on levels of IDO, an enzyme that depletes tryptophan, which is essential for T-cell function. (5) To estimate the influence of concurrent and consolidative MK-3475 on levels of MHC class I (CD8+ T cell ligand) and MICA (NK ligand), as measured by MHC. (6) To estimate the progression free survival (PFS) in subjects with locally advanced cervical cancer treated with sequential and concurrent administration of pembrolizumab in relation to CRT. (7) To estimate the overall survival (OS) in subjects with locally advanced cervical cancer treated with sequential and concurrent administration of pembrolizumab in relation to CRT.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
RADIATION	Brachytherapy	Radiation is done for standard clinical care purposes.
DRUG	Cisplatin	40 mg of chemotherapy drug will be given weekly for 5-6 weeks.

Timeline

• Start date: 2017-02-09
• Primary completion: 2021-01-01
• Completion: 2022-12-14
• First posted: 2015-12-18
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study