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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03599713




Registration number
NCT03599713
Ethics application status
Date submitted
16/07/2018
Date registered
26/07/2018
Date last updated
15/10/2024

Titles & IDs
Public title
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Scientific title
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
Secondary ID [1] 0 0
INCMGA 0012-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Merkel Cell Carcinoma 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

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

Experimental: Retifanlimab: Chemotherapy: Naïve -

Experimental: Retifanlimab: Chemotherapy: Refractory -


Treatment: Drugs: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
up to 26.8 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
up to 24.9 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
up to 26.8 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
up to 26.8 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
up to 33.9 months
Secondary outcome [5] 0 0
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Timepoint [5] 0 0
up to 823 days (up to approximately 2.3 years)
Secondary outcome [6] 0 0
First-dose Cmax of Retifanlimab
Timepoint [6] 0 0
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Secondary outcome [7] 0 0
First-dose Cmin of Retifanlimab
Timepoint [7] 0 0
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Secondary outcome [8] 0 0
First-dose AUC0-t of Retifanlimab
Timepoint [8] 0 0
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1

Eligibility
Key inclusion criteria
* Signed informed consent.
* Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
* Eastern Cooperative Oncology Group performance status of 0 to 1.
* Measurable disease according to RECIST v1.1.
* Availability of tumor tissue (fresh or archival) for central pathology review.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
* Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
* Has not recovered to = Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
* Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* History of second malignancy within 3 years (with exceptions).
* Laboratory values outside the protocol-defined range at screening.
* Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
* Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
* Receipt of a live vaccine within 28 days of planned start of study therapy.
* Current use of protocol-defined prohibited medication.
* Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
* Participant who is pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2024
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent'S Hospital Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
02010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
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United States of America
State/province [4] 0 0
Illinois
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United States of America
State/province [5] 0 0
Kentucky
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United States of America
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Minnesota
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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West Virginia
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Canada
State/province [14] 0 0
Alberta
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Canada
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CA
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Canada
State/province [16] 0 0
Ontario
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Canada
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Quebec
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Czechia
State/province [18] 0 0
Olomouc
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Czechia
State/province [19] 0 0
Praha 4-krc
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha
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France
State/province [21] 0 0
Boulogne-billancourt
Country [22] 0 0
France
State/province [22] 0 0
Marseille Cedex 5
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France
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Nantes Cedex
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France
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Nice Cedex 3
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France
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Paris
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France
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Rouen
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Buxtehude
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Germany
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Erfurt
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Germany
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Essen
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Germany
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Kiel
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Germany
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Marburg
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Germany
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Regensburg
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Germany
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Tubingen
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Italy
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Bari
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Italy
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Candiolo
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Italy
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Genova
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Italy
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Milan
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Italy
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Modena
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Italy
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Naples
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Italy
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Padova
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Italy
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Rome
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Italy
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Siena
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Poland
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Warsaw
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Lausanne
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Switzerland
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Zuerich
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United Kingdom
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Cottingham
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United Kingdom
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London
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United Kingdom
State/province [55] 0 0
Sutton
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).
Trial website
https://clinicaltrials.gov/study/NCT03599713
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Incyte Medical Monitor
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03599713