A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma
Study on the Effectiveness of an Investigational Medication for Merkel Cell Cancer
Brief description of study.
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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Merkel Cell Carcinoma
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Women must not be pregnant or breast-feeding due to the unknown effects of the study drug in this setting
Women of childbearing potential, and sexually active males, on Arm A MK-3475 (pembrolizumab must use accepted and effective method(s) of contraception or abstain from sex from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment. For patients on Arm B only receiving radiation therapy, contraception use should be per institutional standard
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (American Joint Committee on Cancer [AJCC] version 8) I-IIIb.
Stage I patients with negative sentinel lymph node biopsy are ineligible. Patients who have a positive biopsy or for whom no biopsy was done are eligible.
Patients with distant metastatic disease (stage IV) are not eligible.
The primary tumor must have negative margins.
Patients with all macroscopic Merkel cell carcinoma (either identified by physical exam or imaging) have been completely resected by surgery within 8 weeks before registration
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to registration
Patient must have no currently present metastases (as confirmed by standard imaging studies)
Patient must have no previous systemic therapy or radiation therapy for Merkel cell carcinoma
Patients with inoperable disease who have received radiation are not eligible
Patients who are human immunodeficiency virus (HIV)+ with undetectable HIV viral load are eligible provided they meet all other protocol criteria for participation
Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are eligible provided viral loads are undetectable
Patients on suppressive therapy are eligible
Patients must not be on active immunosuppression, have a history of life threatening virus, have had other (beside non-melanoma skin cancers, or recent indolent cancers e.g.: resected low grade prostate cancer) cancer diagnoses in the last two years, or have had immunotherapy of any kind within the last 2 years
Patients must not have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Operative notes from patient's surgical resection must be accessible.
This study investigates the effectiveness of an investigational medication compared to standard observation in patients with stages I-III Merkel cell cancer. Merkel cell cancer is a rare type of skin cancer that can grow quickly and spread to other parts of the body. The study focuses on patients whose cancer has been completely removed by surgery.
Participants in this study will receive either the investigational medication, which is a type of immunotherapy using monoclonal antibodies, or they will continue with standard observation. Immunotherapy may help the immune system attack cancer cells and prevent them from growing and spreading.
- Who can participate: Adults with stage I-III Merkel cell cancer that has been completely removed by surgery may participate. Participants must not have distant metastatic disease or have received previous systemic or radiation therapy for Merkel cell carcinoma. Women must not be pregnant or breastfeeding, and effective contraception is required for those of childbearing potential.
- Study details: Participants will be assigned to receive either the investigational medication or continue with standard observation. The investigational medication is a type of immunotherapy that uses monoclonal antibodies to help the immune system fight cancer.
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