Keynote 826

Patients with persistent, recurrent, or metastatic cervical cancer

Efficacy and Safety Study of First-line Treatment With Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR), or, 2) Overall Survival (OS).

Status:

Recruiting

Phase 3 Icon

Trial Phase

The investigational immunotherapy is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational immunotherapy to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 50% will receive pembrolizumab along with chemotherapy
  • 50% will receive placebo along with chemotherapy


Trial Purpose
18

US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

See Locations

National Trial Reference Number

NCT03635567 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

Print this page or Email it to your doctor to discuss at your next visit

Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Cervical Cancer

Age range

18 — no age maximum

Gender(s)

Female

Trial Purpose

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR), or, 2) Overall Survival (OS).

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

    Location
    Status
  • Anchorage, Alaska, United States, 99508
    Recruiting
  • Phoenix, Arizona, United States, 85016
    Recruiting
  • Orange, California, United States, 92868
    Recruiting
  • Tampa, Florida, United States, 33612
    Recruiting
  • Augusta, Georgia, United States, 30912
    Recruiting
  • Detroit, Michigan, United States, 48201
    Recruiting
  • Detroit, Michigan, United States, 48202
    Recruiting
  • Saint Louis, Missouri, United States, 63110
    Recruiting
  • Teaneck, New Jersey, United States, 07666
    Recruiting
  • New York, New York, United States, 10032
    Recruiting
  • Oklahoma City, Oklahoma, United States, 73104
    Recruiting
  • Tulsa, Oklahoma, United States, 74146
    Recruiting
  • Germantown, Tennessee, United States, 38138
    Recruiting
  • San Antonio, Texas, United States, 78240
    Recruiting
  • Seattle, Washington, United States, 98109
    Recruiting
  • Newark, New Jersey, United States, 07103
    Recruiting
  • New Haven, Connecticut, United States, 06510
    Recruiting
  • New York, New York, United States, 10011
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-826

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.