EA6174 STAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab, a Phase III Trial
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to compare the usual approach of post-surgery observation with or without radiation to using pembrolizumab with or without radiation after surgery.
Patients with stage I-IIIB Merkel Cell Carcinoma (MCC) that has been removed by surgery may be eligible.Inclusion Criteria:•Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1, or 2 (However, those patients 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 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 grossly negative margins. (Microscopically positive margins are allowed).?Cancers of unknown primary that have regional disease only can be included.?Complete nodal dissection is not required for eligibility.•Patients with all macroscopic Merkel cell carcinoma (either identified by physical exam or imaging) have been completely resected by surgery within 16 weeks before registration.•All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 8 weeks prior to registration.•Patient may not have a history of distant metastatic disease.?NOTE: Loco-regional recurrent disease is acceptable, as long as this is not metastatic (prior surgery with or without radiation therapy is acceptable).•For patients with initial presentation of Merkel cell carcinoma, patient must have no previous systemic therapy or radiation therapy prior to surgery for Merkel cell carcinoma and cannot have completed adjuvant radiation therapy for Merkel cell carcinoma more than 6 weeks prior to registration. Patients actively undergoing radiation therapy or having completed adjuvant radiation therapy within 6 weeks of registration are eligible, as long as resection date is within 16 weeks of registration.•White blood count greater than equal to 2000/uL (within 4 weeks prior to randomization).•Absolute neutrophil count (ANC) greater than equal to 1000/uL (within 4 weeks prior to randomization).•Platelets greater than equal to 75 x 10^3/uL (within 4 weeks prior to randomization).•Hemoglobin greater than equal to 8 g/dL ( greater than equal to 80 g/L; may be transfused) (within 4 weeks prior to randomization).•Creatinine equal to less than 2.0 x upper limit of normal (ULN) (within 4 weeks prior to randomization).•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) equal to less than 2.5 x ULN (within 4 weeks prior to randomization).•Total bilirubin equal to less than 2.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (within 4 weeks prior to randomization).•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) invasive 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 has 2 study groups.•Group 1 (Arm A)If you are in this group, you will get the study drug pembrolizumab. You will get this drug through a vein in your arm once every cycle for 1 year. Each cycle lasts 21 days. This study has 17 cycles. You may or may not receive a course of radiation therapy. You should discuss with your study doctor about whether you will receive radiation therapy.There will be about 250 people in this group.•Group 2 (Arm B)If you are in this group, you will be followed for observation for 1 year. You may or may not receive a course of radiation therapy. You should discuss with your study doctor about whether you will receive radiation therapy.There will be about 250 people in this group.We will use a computer to assign you to one of the study groups. This process is called “randomization.” It means that your doctor will not choose and you cannot choose which study group you are in. You will be put into a group by chance. You will have an equal chance of being in Group 1 or Group 2.
08/08/2020 05:02 AM