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

Status
Temporarily Closed
Cancer Type
Neuroendocrine Tumor
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03712605
Protocol IDs
EA6174 (primary)
EA6174
NCI-2018-02217
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.
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