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ECOG-ACRIN EA6174

Status:

Recruiting | Phase III

Official Title:

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

Study Purpose:

This study is being done to see if the chance of cancer growing back can be lowered by adding the study drug, pembrolizumab, after surgery

Interventions:

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

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

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.

Patients must be disease free 8 weeks prior to being randomized.

Patients 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.

Patients 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.

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

Patients 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.

Methodist Health System Trial Code:

ECOG-ACRIN EA6174

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!