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ECOG-ACRIN EA6174

Trial Overview

Official Title

Testing Pembrolizumab versus Observation in Patients with Merkel Cell Carcinoma after Surgery

Study Purpose

To see if the chance of cancer growing back can be lowered by adding the study drug, pembrolizumab, after surgery.

Diagnosis

Merkel Cell Cancer (Stages I-IIIb)

Eligibility

Women cannot be pregnant or breast feeding.

Women able to have children must have a negative blood or urine pregnancy test.

Cancer must be removed 8 weeks before joining the study.

Cancer must not have spread to other parts of the body.

Must be disease free 8 weeks prior to being randomized.

Must not have had chemotherapy or radiation therapy for Merkel cell cancer.

Patients who are HIV positive with undetectable viral loads are eligible.

Patients with Hepatitis B or C with undetectable viral loads are eligible.

Must not be on active immunosuppression, have a history of a life threating virus, or other cancers besides non-melanoma skin cancers or low grade prostate cancer in the last 2 years.

Must not have had immunotherapy of any kind within the last 2 years.

Must not have a history of pneumonitis or have pneumonitis.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Study drug versus follow-up observation
  • Group 1 (Arm A): Pembrolizumab Therapy (Study Group)
  • Group 2 (Arm B): Follow-Up Observation (Usual Approach Group)

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
EA6174
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