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

Active:	Yes
Cancer Type:	Neuroendocrine Tumor Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT03712605
Trial Phases:	Phase III	Protocol IDs:	EA6174 (primary) EA6174 NCI-2018-02217
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	ECOG-ACRIN Cancer Research Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT03712605

Summary

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVE:
I. To compare recurrence free survival (RFS) and overall survival (OS) as co-primary endpoints across the two arms.

SECONDARY OBJECTIVES:
I. To evaluate adverse events.
II. To evaluate distant metastasis free survival (DMFS).
III. To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo positron emission tomography (PET)-computed tomography (CT), CT, or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo blood sample collection as clinically indicated at the discretion of the treating investigator.

ARM B: Patients receive standard of care observation every 3 months for 1 year, and then every 6 months for 5 years. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT, CT, or MRI throughout the trial. Patients may also undergo blood sample collection as clinically indicated at the discretion of the treating investigator.

After completion of study treatment, patients are followed up every 3-6 months for 5 years from the date of registration.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

Doctors:

Barry D. Luskey MD

Lester E. Robertson MD, FACP

Mark A. Taylor MD

Grant C. Lewis MD

Ronald Goldberg MD

Alison Spellman MD

Stephen Andrew White M.D.

Catherine A. Ronaghan M.D., FACS

Yana Puckett

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.