Pembrolizumab + Chemoradiotherapy for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+184 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

Eligibility Criteria

This trial is for women with high-risk locally advanced cervical cancer stages IB2-IIB (node-positive) or III-IVA. They must have certain types of cervical cancer, not have had previous treatments for it, and be immunotherapy-naïve. Participants should be in good health overall, not pregnant or breastfeeding, willing to use contraception, and able to provide a tissue sample.

Inclusion Criteria

My organs are functioning well enough for treatment.

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer can be seen and measured on scans.

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Exclusion Criteria

Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study

I cannot take cisplatin due to health reasons.

Has severe hypersensitivity to pembrolizumab and/or any of its excipients

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Treatment Details

Interventions

Brachytherapy (Radiation)
Cisplatin (Alkylating agents)
External Beam Radiotherapy (EBRT) (Radiation)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study tests if adding pembrolizumab (an immunotherapy drug) to standard chemoradiotherapy improves survival compared to using a placebo with the same chemotherapy and radiation treatment in patients with advanced cervical cancer. The main goal is seeing if the disease progresses more slowly or people live longer with pembrolizumab.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: chemoradiotherapy + placebo for pembrolizumabExperimental Treatment4 Interventions

Participants receive placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).

Group II: chemoradiotherapy + pembrolizumabExperimental Treatment4 Interventions

Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: