NCT04291885

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

A Randomised, Placebo-controlled, Phase II Trial of Adjuvant Avelumab in Patients With Stage I-III Merkel Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Melanoma and Skin Cancer Trials Limited · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Merkel Cell Carcinoma
• Merkel Cell Carcinoma, Stage I
• Merkel Cell Carcinoma, Stage II
• Merkel Cell Carcinoma, Stage III
• Neuroendocrine Tumors
• Carcinoma Neuroendocrine Skin

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab IV infusion
DRUG	Placebo	Placebo IV infusion

Timeline

• Start date: 2020-10-26
• Primary completion: 2027-04-01
• Completion: 2030-04-30
• First posted: 2020-03-02
• Last updated: 2026-04-09

Locations

20 sites across 2 countries: Australia, New Zealand