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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04291885




Registration number
NCT04291885
Ethics application status
Date submitted
6/02/2020
Date registered
2/03/2020

Titles & IDs
Public title
Immunotherapy Adjuvant Trial in Patients with Stage I-III Merkel Cell Carcinoma
Scientific title
A Randomised, Placebo-controlled, Phase II Trial of Adjuvant Avelumab in Patients with Stage I-III Merkel Cell Carcinoma
Secondary ID [1] 0 0
03.18
Universal Trial Number (UTN)
Trial acronym
I-MAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Merkel Cell Carcinoma 0 0
Merkel Cell Carcinoma, Stage I 0 0
Merkel Cell Carcinoma, Stage II 0 0
Merkel Cell Carcinoma, Stage III 0 0
Neuroendocrine Tumors 0 0
Carcinoma Neuroendocrine Skin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - Placebo

Experimental: Avelumab - 6 months of Avelumab at a dose of 800mg as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)

Placebo comparator: Placebo - 6 months of Placebo as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)


Treatment: Drugs: Avelumab
Avelumab IV infusion

Treatment: Drugs: Placebo
Placebo IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence-free survival (RFS)
Timepoint [1] 0 0
24 Months
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
24 Months
Secondary outcome [2] 0 0
Disease-specific survival (DSS)
Timepoint [2] 0 0
24 Months
Secondary outcome [3] 0 0
Rate of loco-regional failure free survival (LRFFS)
Timepoint [3] 0 0
24 Months
Secondary outcome [4] 0 0
Distant metastasis-free survival (DMFS)
Timepoint [4] 0 0
24 Months
Secondary outcome [5] 0 0
Treatment toxicity and tolerability as assessed by NCI CTCAE v5.0
Timepoint [5] 0 0
24 Months
Secondary outcome [6] 0 0
Patient-reported quality of life (QoL) as assessed by FACT-M questionnaire
Timepoint [6] 0 0
24 Months

Eligibility
Key inclusion criteria
1. 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).
2. Absence of distant metastatic disease on baseline 18-Fludeoxyglucose (18FDG) - Positron Emission Tomography (PET) / Computed Tomography (CT) scan.
3. 18 years of age or older.
4. Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
5. Willing and able to provide written informed consent and comply with all study requirements.
6. Adequate haematological, liver and renal function as determined by the screening laboratory values outlined in the protocol obtained within 14 days prior to randomisation.
7. Agreeable to collection of archival tumour material. Where possible, the most recently acquired tumour specimen should be provided.
8. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
3. 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.
4. Prior treatment with other immune-modulating agents that was within fewer than 28 days prior to the first dose of Avelumab.
5. Active infection requiring antibiotics within 7 days of cycle 1 day 1 of study drug dose.
6. Active tuberculosis.
7. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
8. 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.
9. 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
10. 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.
11. Pregnant or breastfeeding.
12. 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).
13. Uncontrolled cardiac disease including not limited to symptomatic congestive heart failure, unstable angina pectoris, life-threatening cardiac arrhythmia
14. 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).
15. Use of live attenuated vaccines within 28 days of first dose of Avelumab.
16. Any acute or chronic psychiatric problems that, in the opinion of the Investigator, make the patient ineligible for participation due to compliance concerns.
17. Patients with prior allogeneic stem cell or solid organ transplantation.
18. Patients who are involuntarily incarcerated.
19. Evidence of other malignancy in the past 3 years, with exception of tumours with negligible risk of metastasis or death.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2030
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [3] 0 0
Melanoma Institute Australia - Sydney
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Sydney
Recruitment hospital [6] 0 0
Calvary Mater Hospital - Sydney
Recruitment hospital [7] 0 0
Cancer Care Wollongong - Wollongong
Recruitment hospital [8] 0 0
Royal Brisbane and Woman's Hospital - Brisbane
Recruitment hospital [9] 0 0
Cancer Care Service, Bundaberg Base Hospital - Bundaberg
Recruitment hospital [10] 0 0
Cairns Hospital - Cairns
Recruitment hospital [11] 0 0
Cancer Care Service, Hervey Bay Hospital - Hervey Bay
Recruitment hospital [12] 0 0
Mackay Hospital and Health Service - Mackay
Recruitment hospital [13] 0 0
Tasman Health Care - Southport
Recruitment hospital [14] 0 0
Townsville Hospital - Townsville
Recruitment hospital [15] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [16] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [17] 0 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [18] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [19] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
2298 - Sydney
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4029 - Brisbane
Recruitment postcode(s) [8] 0 0
4670 - Bundaberg
Recruitment postcode(s) [9] 0 0
4870 - Cairns
Recruitment postcode(s) [10] 0 0
4655 - Hervey Bay
Recruitment postcode(s) [11] 0 0
4740 - Mackay
Recruitment postcode(s) [12] 0 0
4215 - Southport
Recruitment postcode(s) [13] 0 0
- Townsville
Recruitment postcode(s) [14] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [15] 0 0
5000 - Adelaide
Recruitment postcode(s) [16] 0 0
7000 - Hobart
Recruitment postcode(s) [17] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wen Xu, MBBS, FRACP
Address 0 0
Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melanoma and Skin Cancer Trials Ltd Project officer
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 9022
Fax 0 0
Email 0 0
imat@masc.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04291885