Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma (I-MAT)
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|ClinicalTrials.gov Identifier: NCT04291885|
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : July 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma Merkel Cell Carcinoma, Stage I Merkel Cell Carcinoma, Stage II Merkel Cell Carcinoma, Stage III Neuroendocrine Tumors Carcinoma Neuroendocrine Skin||Drug: Avelumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Placebo-controlled, Phase II Trial of Adjuvant Avelumab in Patients With Stage I-III Merkel Cell Carcinoma|
|Actual Study Start Date :||October 8, 2020|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2028|
6 months of Avelumab at a dose of 800mg as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)
Avelumab IV infusion
Placebo Comparator: Placebo
6 months of Placebo as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)
Placebo IV infusion
- Recurrence-free survival (RFS) [ Time Frame: 24 Months ]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.
- Overall survival (OS) [ Time Frame: 24 Months ]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.
- Disease-specific survival (DSS) [ Time Frame: 24 Months ]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
- Rate of loco-regional failure free survival (LRFFS) [ Time Frame: 24 Months ]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.
- Distant metastasis-free survival (DMFS) [ Time Frame: 24 Months ]DMFS is defined as the time from treatment initiation to the first evidence of distant metastatic disease.
- Treatment toxicity and tolerability as assessed by NCI CTCAE v5.0 [ Time Frame: 24 Months ]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.
- Patient-reported quality of life (QoL) as assessed by FACT-M questionnaire [ Time Frame: 24 Months ]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).
- Rate of Merkel cell polyomavirus positivity in stage I-III Merkel cell carcinoma [ Time Frame: 24 Months ]To identify Merkel cell polyomavirus MCPyV virus status. To correlate viral aetiology-rate of Merkel cell polyomavirus (MCPyV) positivity in pathology specimens in stage I-III Merkel cell carcinoma with outcome from adjuvant treatment.
- Correlating whole exome sequencing (WES) and ribonucleic acid (RNA) expression with immunotherapy response and outcomes in early stage MCC [ Time Frame: 24 Months ]To evaluate the relationship between somatic mutations in cancer genes or the total mutation burden of the cancer with immunotherapy response and outcome following adjuvant therapy.
- Correlating immune infiltrates by multiplex immunohistochemistry (IHC) with survival endpoints [ Time Frame: 24 Months ]To address whether immune infiltrates and PD-L1 expression are associated with survival.
- Utility of circulating biomarkers in predicting recurrence in early stage MCC [ Time Frame: 24 Months ]To identify predictive biomarkers for response and resistance to immunotherapy in patients with stage I-III MCC using archival tissue and peripheral blood.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291885
|Contact: Melanoma and Skin Cancer Trials Ltd Project officer||+61 3 9903 firstname.lastname@example.org|
|Study Chair:||Wen Xu, MBBS, FRACP||Princess Alexandra Hospital|