Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma (I-MAT)

STATUS

Recruiting
End date

Dec 15, 2028
participants needed

132
sponsor

Melanoma and Skin Cancer Trials Limited

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Updated on 7 October 2022

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ct scan

renal function

carcinoma

metastasis

avelumab

positron emission tomography

18f-fdg

immunomodulator

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.

Description

The I-MAT trial is a phase II, prospective, randomised, placebo-controlled, multi-institutional trial for patients with stage I-III Merkel cell carcinoma (MCC). Participants on the trial will receive either avelumab or placebo for 6 months. The primary aim of the I-MAT trial is to develop an effective, well-tolerated adjuvant immunotherapy regimen for patients with stage I-III MCC, post a range of definitive loco-regional treatment options.

Details

Condition	Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Neuroendocrine Tumors, Carcinoma Neuroendocrine Skin
Treatment	Placebo, Avelumab
Clinical Study Identifier	NCT04291885
Sponsor	Melanoma and Skin Cancer Trials Limited
Last Modified on	7 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically confirmed Merkel cell carcinoma (MCC) which is either
	clinical stage I
	pathological stage I with positive LVSI only
	clinical or pathological stage II (including IIA and IIB)
	clinical or pathological stage III (including IIIA and IIIB)
	Absence of distant metastatic disease on baseline 18-Fludeoxyglucose (18FDG) -
	18 years of age or older
	Positron Emission Tomography (PET) / Computed Tomography (CT) scan
	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 study entry
	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
	Any systemic anti-cancer treatment (chemotherapy, targeted systemic therapy) investigational or standard of care, within 28 days of the first dose of Avelumab or planned to occur during the study period. Patients receiving bisphosphonates or denosumab will not be excluded
	Current use of immunosuppressive medication, except for the following: a. intranasal, inhaled, topical steroids, or local steroid injection ; b. systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. steroids as premedication for hypersensitivity reactions
	Pregnant or breastfeeding
	History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organising pneumonia (i.e., bronchiolitis obliterans, cryptogenic organising pneumonia), or evidence of active pneumonitis on screening chest CT scan)
	Uncontrolled cardiac disease including not limited to symptomatic congestive heart failure, unstable angina pectoris, life-threatening cardiac arrhythmia
	Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5 Grade 3)
	Use of live attenuated vaccines within 28 days of first dose of Avelumab
	Any acute or chronic psychiatric problems that, in the opinion of the Investigator, make the patient ineligible for participation due to compliance concerns
	Patients with prior allogeneic stem cell or solid organ transplantation
	Patients who are involuntarily incarcerated
	No evidence of other malignancy in the past 3 years, with exception of tumours with negligible risk of metastasis or death

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Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma (I-MAT)