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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03599713
Ethics application status
Date submitted
16/07/2018
Date registered
26/07/2018
Date last updated
4/06/2020

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: INCMGA00012 -


Treatment: Drugs: Retifanlimab
INCMGA00012 administered at the recommended Phase 2 dose by IV infusion once every 28 days.

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

Outcomes
Primary outcome [1] 0 0
Overall response rate in chemotherapy-naive participants - Defined as the percentage of participants with an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central radiographic review (ICR).
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Overall response rate in the full study population (chemotherapy-naive and chemotherapy-refractory participants) - Defined as the percentage of participants with an objective response (CR or PR) according to RECIST v1.1 as determined by ICR.
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Duration of response in the chemotherapy-naive and full study populations - Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by ICR or death due to any cause.
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Disease control rate in the chemotherapy-naive and full study populations - Defined as the proportion of participants with either an objective response or stable disease lasting at least 6 months.
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Progression-free survival in the chemotherapy-naive and full study populations - Defined as the time from the start of therapy until disease progression as determined by the ICR or death due to any cause.
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Overall survival in the chemotherapy-naive and full study populations - Defined as the time from the start of therapy until death due to any cause.
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Number of treatment-emergent adverse events - Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Timepoint [6] 0 0
Up to approximately 27 months
Secondary outcome [7] 0 0
Cmax of INCMGA00012 - Maximum observed serum concentration.
Timepoint [7] 0 0
Up to approximately 6 months
Secondary outcome [8] 0 0
tmax of INCMGA00012 - Time to maximum concentration.
Timepoint [8] 0 0
Up to approximately 6 months
Secondary outcome [9] 0 0
Cmin of INCMGA00012 - Minimum observed serum concentration over the dose interval.
Timepoint [9] 0 0
Up to approximately 6 months
Secondary outcome [10] 0 0
AUCt of INCMGA00012 - Area under the serum concentration-time curve.
Timepoint [10] 0 0
Up to approximately 6 months

Eligibility
Key inclusion criteria
- Signed informed consent.

- Diagnosis of MCC with distant metastatic disease or recurrent advanced locoregional
disease not amendable to surgery or radiation and no more than 3 prior systemic
treatments, inclusive of systemic adjuvant therapy.

- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1
(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
N/A
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
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - 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
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
Canada
State/province [11] 0 0
Calgary
Country [12] 0 0
Canada
State/province [12] 0 0
Edmonton
Country [13] 0 0
Canada
State/province [13] 0 0
London
Country [14] 0 0
Canada
State/province [14] 0 0
Montréal
Country [15] 0 0
Czechia
State/province [15] 0 0
Olomouc
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha
Country [17] 0 0
France
State/province [17] 0 0
Cedex
Country [18] 0 0
France
State/province [18] 0 0
Boulogne-Billancourt
Country [19] 0 0
France
State/province [19] 0 0
Nantes
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Rouen
Country [22] 0 0
France
State/province [22] 0 0
Villejuif
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Kehl
Country [25] 0 0
Hungary
State/province [25] 0 0
Budapest
Country [26] 0 0
Italy
State/province [26] 0 0
Via Gattamelata
Country [27] 0 0
Italy
State/province [27] 0 0
Bari
Country [28] 0 0
Italy
State/province [28] 0 0
Candiolo
Country [29] 0 0
Italy
State/province [29] 0 0
Genova
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Modena
Country [32] 0 0
Italy
State/province [32] 0 0
Napoli
Country [33] 0 0
Italy
State/province [33] 0 0
Rome
Country [34] 0 0
Italy
State/province [34] 0 0
Siena
Country [35] 0 0
Poland
State/province [35] 0 0
Roentgena 5
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Switzerland
State/province [39] 0 0
Zürich
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Treliske
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Cottingham
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Sutton

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/show/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
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
medinfo@incyte.com
Contact person for scientific queries

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