Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma (NCT04291885) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma
Australia122 participantsStarted 2020-10-26
Plain-language summary
The I-MAT trial is a randomised, placebo-controlled, phase II trial of adjuvant Avelumab in patients with stage I-III Merkel cell carcinoma aiming to explore the efficacy of avelumab as adjuvant immunotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed Merkel cell carcinoma (MCC) which is either:
✓. Absence of distant metastatic disease on baseline 18-Fludeoxyglucose (18FDG) - Positron Emission Tomography (PET) / Computed Tomography (CT) scan.
✓. 18 years of age or older.
✓. Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
✓. Willing and able to provide written informed consent and comply with all study requirements.
✓. Adequate haematological, liver and renal function as determined by the screening laboratory values outlined in the protocol obtained within 14 days prior to randomisation.
✓. Agreeable to collection of archival tumour material. Where possible, the most recently acquired tumour specimen should be provided.
✓. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of treatment.
Exclusion criteria
✕. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest significant risk for immune-related adverse events.
✕. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
✕. Previous cancer immunotherapy, specifically interferon, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways are not permitted.
✕. Prior treatment with other immune-modulating agents that was within fewer than 28 days prior to the first dose of Avelumab.
✕. Active infection requiring antibiotics within 7 days of cycle 1 day 1 of study drug dose.
✕. Active tuberculosis.
✕. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
✕. Uncontrolled infection with hepatitis B or hepatitis C virus (HBV or HCV) infection; Patients with previously successfully treated HCV, with positive anti-HCV antibody but undetectable (HCV) ribonucleic acid (RNA) levels are allowed on trial.