Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer

Summary

This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.

Conditions

• Locally Advanced Cervical Adenocarcinoma
• Locally Advanced Cervical Adenosquamous Carcinoma
• Locally Advanced Cervical Squamous Cell Carcinoma
• Stage IIIA Cervical Cancer FIGO 2018
• Stage IIIB Cervical Cancer FIGO 2018
• Stage IIIC1 Cervical Cancer FIGO 2018
• Stage IIIC2 Cervical Cancer FIGO 2018
• Stage IVA Cervical Cancer FIGO 2018

Interventions

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

RADIATION

Brachytherapy

Undergo brachytherapy

DRUG

Carboplatin

Given IV

PROCEDURE

Chest Radiography

Undergo chest x-ray

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

RADIATION

External Beam Radiation Therapy

Undergo EBRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Jyoti S Mayadev · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-05

Primary Completion

2030-12-31

Completion

2030-12-31

FDA Drug

Yes

Countries

• United States

Study Locations