A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

April 9, 2024 updated by: Incyte Corporation

A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 02010
        • St Vincent's Hospital Sydney
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • CA
      • Calgary Ab, CA, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre Lhsc - South Street Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre/Glen Site/Cedars Cancer Centre
  • Czechia
      • Olomouc, Czechia, 775 20
        • Fakultní Nemocnice Olomouc
      • Praha, Czechia, 110 00
        • Prof Mudr Petr Arenberger Drsc Mba
      • Praha, Czechia, 180-81
        • Nemocnice Na Bulovce
      • Praha 4-krc, Czechia, 140 59
        • Thomayerova nemocnice
  • France
      • Boulogne-billancourt, France, 92100
        • H�PITAL AMBROISE PAR
      • Marseille Cedex 5, France, 13385
        • Chu Hopital de La Timone
      • Nantes Cedex, France, 44093
        • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
      • Nice Cedex 3, France, 06202
        • CHU DE NICE - H�PITAL L'ARCHET 1
      • Paris, France, 75 010
        • Hospital Saint Louis
      • Rouen, France, 76031
        • HOPITAL CHARLES NICOLLE CHU ROUEN - H�PITAL DE BOIS-GUILLAUME
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
      • Buxtehude, Germany, 21614
        • Elbe Klinikum Buxtehude
      • Erfurt, Germany
        • Helios Klinikum Erfurt
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Marburg, Germany, 35043
        • Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
      • Regensburg, Germany, 93053
        • University Hospital Regensburg
      • Tubingen, Germany, 72076
        • Universitaetsklinikum in Tubingen
  • Hungary
      • Budapest, Hungary, 01122
        • National Institute of Oncology
      • Debrecen, Hungary, 04032
        • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
      • Szeged, Hungary, 06720
        • Szte Borgyogyszati Es Allergologiai Klinika
  • Italy
      • Bari, Italy, 70124
        • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
      • Candiolo, Italy, 10060
        • Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
      • Genova, Italy, 16132
        • Irccs Azienda Ospedaliera Universitaria San Martino
      • Milan, Italy, 20133
        • Fondazione Irccs Istituto Nazionale Dei Tumori
      • Milan, Italy, 20141
        • European Institute of Oncology
      • Modena, Italy, 41124
        • A.O.U. di Modena - Policlinico
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
      • Padova, Italy, 35128
        • Iov - Istituto Oncologico Veneto Irccs
      • Rome, Italy, 00167
        • ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
  • Poland
      • Warsaw, Poland, 02-781
        • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08035
        • Hospital General Universitario Vall D Hebron
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
  • Switzerland
      • Lausanne, Switzerland, 01011
        • Centre Hospitalier Universitaire Vaudois (Chuv)
      • Zuerich, Switzerland, 08091
        • Universitatsspital Zurich
  • United Kingdom
      • Cottingham, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden Nhs Foundation Trust - Sutton
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital Truro Sunrise Centre
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute
      • San Francisco, California, United States, 94143
        • University of California San Francisco Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center, Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of Nj
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Upmc Cancercenter
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Fairfax Hospital
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington - Seattle Cancer Care Alliance
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retifanlimab: Chemotherapy: Refractory
Drug: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Other Names:
  • INCMGA00012
  • MGA012
Experimental: Retifanlimab: Chemotherapy: Naïve
Drug: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Other Names:
  • INCMGA00012
  • MGA012

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 26.8 months
ORR was defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by Independent Central Radiographic Review (ICR), at any post-Baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to 26.8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: up to 24.9 months
DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until PD, or death due to any cause, as determined by ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. A Kaplan-Meier estimate (estimated median) of the distribution function is reported.
up to 24.9 months
Disease Control Rate (DCR)
Time Frame: up to 26.8 months
DCR was defined as the percentage of participants with a confirmed overall response (CR and PR) or stable disease (SD) (non-CR/non-PD) lasting at least 6 months from the start of treatment, until the first PD or new anti-cancer therapy, per RECIST v1.1 as determined by ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to 26.8 months
Progression-free Survival (PFS)
Time Frame: up to 26.8 months
According to RESIST v1.1, PFS was defined the time from the start of therapy until disease progression, or death due to any cause, as determined by ICR. Evaluation of target lesions: PD: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered PD). Evaluation of non-target lesions: PD: Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered PD).
up to 26.8 months
Overall Survival
Time Frame: up to 33.9 months
Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
up to 33.9 months
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time Frame: up to 823 days (up to approximately 2.3 years)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset on/after starting a new anticancer therapy was not summarized as a TEAE.
up to 823 days (up to approximately 2.3 years)
First-dose Cmax of Retifanlimab
Time Frame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Cmax was defined as the maximum observed plasma concentration.
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
First-dose Cmin of Retifanlimab
Time Frame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Cmin was defined as the minimum observed plasma concentration over the dose interval.
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
First-dose AUC0-t of Retifanlimab
Time Frame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to time t.
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

January 21, 2022

Study Completion (Estimated)

June 28, 2024

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCMGA 0012-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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