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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2028
  • participants needed
    132
  • sponsor
    Melanoma and Skin Cancer Trials Limited
Updated on 28 July 2021
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, following local and regional treatment options which includes surgery and/or radiotherapy.

Details
Condition Neuroendocrine Tumor, Neuroectodermal Tumor, Neuroendocrine carcinoma, Merkel cell carcinoma, Neurectoderma, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, neuroendocrine tumors, neuroendocrine tumour, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III
Treatment Placebo, Avelumab
Clinical Study IdentifierNCT04291885
SponsorMelanoma and Skin Cancer Trials Limited
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed Merkel cell carcinoma (MCC) which is either
clinical stage I (pathological stage I MCC patients are not eligible for the study)
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) - 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 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
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
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
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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