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Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Trial

NCT03712605 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Pathologic Stage I Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage II Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8

Interventions

OTHER

Best Practice

Receive standard of care observation

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

PROCEDURE

Computed Tomography

Undergo PET-CT or CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Janice Mehnert · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712605 on ClinicalTrials.gov