Trial Purpose

This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03783078

When speaking to your doctor, please have the trial identifier number available.

About The Trial

All of the participants in this trial will receive pembrolizumab. This trial is open to adult participants, as well as to pediatric participants 12 years of age and over.

100% will receive pembrolizumab

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Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.

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Dates

  • Actual study start date February 25, 2019
  • Estimated primary completion date February 15, 2022
  • Estimated study completion date June 16, 2032

Eligibility

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Conditions

Merkel Cell Carcinoma

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Age Range

12 - No Age Maximum

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Sex

All

Trial locations

What Can You Do Next?

If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.

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Discuss With Your Doctor

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CLINICALTRIALS.GOV IDENTIFIER:

NCT03783078

When speaking to your doctor, please have the trial identifier number available.

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.