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

Metastatic Merkel Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03599713
• Other study ID #: INCMGA 0012-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 25, 2019
• Est. completion date: June 28, 2024

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: June 28, 2024
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Metastatic Merkel Cell Carcinoma

Intervention

Drug:
• Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks

Locations

Country	Name	City	State
Australia	St Vincent'S Hospital Sydney	Darlinghurst	New South Wales
Canada	Tom Baker Cancer Centre	Calgary Ab	CA
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	London Health Sciences Centre Lhsc - South Street Hospital	London	Ontario
Canada	McGill University Health Centre/Glen Site/Cedars Cancer Centre	Montreal	Quebec
Canada	Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr	Montreal	Quebec
Czechia	Fakultni Nemocnice Olomouc	Olomouc
Czechia	Nemocnice Na Bulovce	Praha
Czechia	Prof Mudr Petr Arenberger Drsc Mba	Praha
Czechia	Thomayerova Nemocnice	Praha 4-krc
France	H�PITAL AMBROISE PAR	Boulogne-billancourt
France	Chu Hopital de La Timone	Marseille Cedex 5
France	Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu	Nantes Cedex
France	CHU DE NICE - H�PITAL L'ARCHET 1	Nice Cedex 3
France	Hospital Saint Louis	Paris
France	HOPITAL CHARLES NICOLLE CHU ROUEN - H�PITAL DE BOIS-GUILLAUME	Rouen
France	Institut Gustave Roussy	Villejuif Cedex
Germany	Charite Universitaetsmedizin Berlin - Campus Charite Mitte	Berlin
Germany	Elbe Klinikum Buxtehude	Buxtehude
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Universitatsklinikum Essen	Essen
Germany	Universitatsklinikum Schleswig-Holstein	Kiel
Germany	Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin	Marburg
Germany	University Hospital Regensburg	Regensburg
Germany	Universitaetsklinikum in Tubingen	Tubingen
Hungary	National Institute of Oncology	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika	Debrecen
Hungary	Szte Borgyogyszati Es Allergologiai Klinika	Szeged
Italy	Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari	Bari
Italy	Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo	Candiolo
Italy	Irccs Azienda Ospedaliera Universitaria San Martino	Genova
Italy	European Institute of Oncology	Milan
Italy	Fondazione Irccs Istituto Nazionale Dei Tumori	Milan
Italy	A.O.U. Di Modena - Policlinico	Modena
Italy	Istituto Nazionale Tumori Irccs Fondazione Pascale	Naples
Italy	Iov - Istituto Oncologico Veneto Irccs	Padova
Italy	ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA	Rome
Italy	Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte	Siena
Poland	Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie	Warsaw
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital General Universitario Vall D Hebron	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Switzerland	Centre Hospitalier Universitaire Vaudois (Chuv)	Lausanne
Switzerland	Universitatsspital Zurich	Zuerich
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	Royal Free London Nhs Foundation Trust	London
United Kingdom	The Royal Marsden Nhs Foundation Trust	London
United Kingdom	The Royal Marsden Nhs Foundation Trust - Sutton	Sutton
United Kingdom	Royal Cornwall Hospital Truro Sunrise Centre	Truro
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rush University	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Inova Fairfax Hospital	Fairfax	Virginia
United States	John Theurer Cancer Center, Hackensack University Medical Center	Hackensack	New Jersey
United States	Norton Cancer Institute	Louisville	Kentucky
United States	West Virginia University Hospitals Inc	Morgantown	West Virginia
United States	Rutgers Cancer Institute of Nj	New Brunswick	New Jersey
United States	Stanford Cancer Institute	Palo Alto	California
United States	Upmc Cancercenter	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California San Francisco Comprehensive Cancer Center	San Francisco	California
United States	University of Washington - Seattle Cancer Care Alliance	Seattle	Washington
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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	Duration of Response (DOR)	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
Secondary	Disease Control Rate (DCR)	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
Secondary	Progression-free Survival (PFS)	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
Secondary	Overall Survival	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
Secondary	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	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)
Secondary	First-dose Cmax of Retifanlimab	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
Secondary	First-dose Cmin of Retifanlimab	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
Secondary	First-dose AUC0-t of Retifanlimab	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