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Clinical Trial 20040
Cancer Type: Cutaneous
Interventions:Pembrolizumab (Keytruda)
Study Type: Treatment
Phase of Study: Phase III
Investigators:
- Andrew Brohl
Call 813-745-6100 or 1-800-679-0775
Overview
Study Title
A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma
Summary
Objective
To compare Overall Survival (OS) and Recurrence Free Survival (RFS) as co-primary endpoints across the two arms. To evaluate adverse events. To evaluate Distant Metastasis Free Survival (DMFS). To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS).
Inclusion Criteria
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1, or 2 (However, those Participants with a performance state of 3 because they are wheel chair bound due to congenital or traumatic events more than one year before the diagnosis of Merkel cell carcinoma are eligible). Women must not be pregnant or breast-feeding due to the unknown effects of the study drug in this setting. All women of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 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 Participants on Arm B only receiving radiation therapy, contraception use should be per institutional standard. Participant 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 Participants with negative sentinel lymph node biopsy are ineligible. Participants who have a positive biopsy or for whom no biopsy was done are eligible. Participants with distant metastatic disease (stage IV) are not eligible. The primary tumor must have negative margins. Participants 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 Participants must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to registration. White blood count >= 2000/uL (within 4 weeks prior to randomization). Absolute neutrophil count (ANC) >= 1000/Ul (within 4 weeks prior to randomization). Platelets >= 75 x 10^3/uL (within 4 weeks prior to randomization).
Hemoglobin >= 8 g/dL (>= 80 g/L; may be transfused) (within 4 weeks prior to randomization). Creatinine =>Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =>Total bilirubin =>Operative notes from Participant's surgical resection must be accessible.
Exclusion Criteria
Participant must have no currently present metastases (as confirmed by standard imaging studies). Participant must have no previous systemic therapy or radiation therapy for Merkel cell carcinoma. Participants with inoperable disease who have received radiation are not eligible. Participants who are human immunodeficiency virus (HIV)+ with undetectable HIV viral load are eligible provided they meet all other protocol criteria for participation. Participants with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are eligible provided viral loads are undetectable. Participants on suppressive therapy are eligible. Participants 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. Participants must not have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
