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Merkel Cell CarcinomaPhase 2I-MATNCT04291885

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

A Phase 2 study testing Avelumab in people with Merkel Cell Carcinoma and Merkel Cell Carcinoma, Stage I, run by Melanoma and Skin Cancer Trials Limited at 20 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
20 sitesin 2 countries
Study dates
26 Oct 2020to 30 Apr 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) - Positron Emission Tomography (PET) / Computed Tomography (CT) scan.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Evidence of other malignancy in the past 3 years, with exception of tumours with negligible risk of metastasis or death.

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

Australia19 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Brisbane and Woman's Hospital

    Brisbane, Queensland, 4029

  • Cancer Care Service, Bundaberg Base Hospital

    Bundaberg, Queensland, 4670

  • Cairns Hospital

    Cairns, Queensland, 4870

  • Cancer Care Service, Hervey Bay Hospital

    Hervey Bay, Queensland, 4655

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • Mackay Hospital and Health Service

    Mackay, Queensland, 4740

  • Alfred Hospital

    Melbourne, Victoria, 3000

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • Tasman Health Care

    Southport, Queensland, 4215

  • Chris O'Brien Lifehouse

    Sydney, New South Wales, 2050

  • Melanoma Institute Australia

    Sydney, New South Wales, 2065

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

  • Westmead Hospital

    Sydney, New South Wales, 2145

  • Calvary Mater Hospital

    Sydney, New South Wales, 2298

  • Townsville Hospital

    Townsville, Queensland

  • Cancer Care Wollongong

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

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

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.

Read the 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.

Being tested
Avelumab, Placebo
Medical subject headings
Carcinoma, Merkel Cell, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    Also called anti-PD-L1, Bavencio

    Avelumab IV infusion

  • PlaceboDrug

    Placebo IV infusion

Study groups in NCT04291885
Study groupRoleWhat they receive
AvelumabExperimental6 months of Avelumab at a dose of 800mg as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)
Receives: Drug: Avelumab
PlaceboPlacebo comparator6 months of Placebo as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-free survival (RFS)

    Recurrence-free survival (RFS) as the primary endpoint, is anticipated to be analysed over an average planned follow-up of 3.5 years. An analysis of RFS at the 24 month time point of follow-up will also be conducted as it is anticipated that the minimum follow-up for participants will be 24 months and the sample size rationale utilises RFS rates at 24 months in historical controls. RFS is defined as the time from treatment initiation until the first date of any signs or symptoms of recurrence of tumour.

    Measured: 24 Months

Secondary outcomes (6)

  1. Overall survival (OS)

    Overall survival rates at 12 and 24 months. Overall survival is defined as the time from treatment initiation to the date of death due to any cause.

    Measured: 24 Months

  2. Disease-specific survival (DSS)

    Disease-specific survival at 24 months from treatment initiation. Disease-specific survival is the percentage of participants who have not died from Merkel Cell Carcinoma

    Measured: 24 Months

  3. Rate of loco-regional failure free survival (LRFFS)

    Rate of loco-regional failure free survival (LRFFS) is defined as the time from treatment initiation to the first recurrence of the loco-regional tumour.

    Measured: 24 Months

  4. Distant metastasis-free survival (DMFS)

    DMFS is defined as the time from treatment initiation to the first evidence of distant metastatic disease.

    Measured: 24 Months

  5. Treatment toxicity and tolerability as assessed by NCI CTCAE v5.0

    Rate of treatment-related adverse events (AEs). Safety will be measured by serious adverse events (SAEs) and AEs assessed as per NCI CTCAE v5.0, including immune-related adverse events.

    Measured: 24 Months

  6. Patient-reported quality of life (QoL) as assessed by FACT-M questionnaire

    FACT-M form (version 4) will be utilised. This will include patient-reported questions relating to physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and additional patient concerns which are measured from 0-4 (Not at all - Very Much).

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start26 Oct 2020
  3. Primary completion10 Nov 2026 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291885
Sponsor's protocol ID
03.18
Acronym
I-MAT
Status last verified
Oct 2026
First submitted
6 Feb 2020
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab in people with Merkel Cell Carcinoma and Merkel Cell Carcinoma, Stage I, run by Melanoma and Skin Cancer Trials Limited at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free survival (RFS) (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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