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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001627-39 | EudraCT Number |
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The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retifanlimab: Chemotherapy: Naïve | Experimental |
| |
| Retifanlimab: Chemotherapy: Refractory | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retifanlimab | Drug | INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Palo Alto | California | 94304 | United States | ||
| University of California San Francisco Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40796223 | Derived | Grignani G, Rutkowski P, Lebbe C, Guida M, Gaudy-Marqueste C, Spagnolo F, Burgess M, Morano F, Montaudie H, Depenni R, Spada F, Yeung CCS, Pulini J, Cornfeld M, Tian C, Bhatia S. Phase II study of retifanlimab in patients with recurrent locally advanced or metastatic Merkel cell carcinoma (POD1UM-201). J Immunother Cancer. 2025 Aug 11;13(8):e012478. doi: 10.1136/jitc-2025-012478. |
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Participants were enrolled and treated at 34 study centers in Italy, France, the United States, Poland, Canada, Switzerland, Hungary, the Czech Republic, Germany, Spain, and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy: Naïve | Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2021 | Apr 7, 2023 |
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|
| up to 55.3 months |
| 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 57.1 months |
| 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 57.1 months |
| 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 60.4 months |
| 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 846 days (up to approximately 2.3 years) |
| 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 |
| 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 |
| 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 |
| San Francisco |
| California |
| 94143 |
| United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40241 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of Nj | New Brunswick | New Jersey | 08901 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Upmc Cancercenter | Pittsburgh | Pennsylvania | 15232 | United States |
| Inova Fairfax Hospital | Fairfax | Virginia | 22031 | United States |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| West Virginia University Hospitals Inc | Morgantown | West Virginia | 26506 | United States |
| St Vincent'S Hospital Sydney | Darlinghurst | New South Wales | 02010 | Australia |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Tom Baker Cancer Centre | Calgary AB | CA | T2N 4N2 | Canada |
| London Health Sciences Centre Lhsc - South Street Hospital | London | Ontario | N6A 4G5 | Canada |
| Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr | Montreal | Quebec | H3T1E2 | Canada |
| McGill University Health Centre/Glen Site/Cedars Cancer Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Fakultni Nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Prof Mudr Petr Arenberger Drsc Mba | Prague | 110 00 | Czechia |
| Nemocnice Na Bulovce | Prague | 180-81 | Czechia |
| Thomayerova Nemocnice | Praha 4-krc | 140 59 | Czechia |
| H�PITAL AMBROISE PAR | Boulogne-Billancourt | 92100 | France |
| Chu Hopital de La Timone | Marseille | 13385 | France |
| Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu | Nantes | 44093 | France |
| CHU DE NICE - H�PITAL L'ARCHET 1 | Nice | 06202 | France |
| Hospital Saint Louis | Paris | 75 010 | France |
| HOPITAL CHARLES NICOLLE CHU ROUEN - H�PITAL DE BOIS-GUILLAUME | Rouen | 76031 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | 10117 | Germany |
| Elbe Klinikum Buxtehude | Buxtehude | 21614 | Germany |
| Helios Klinikum Erfurt | Erfurt | Germany |
| Universitatsklinikum Essen | Essen | 45122 | Germany |
| Universitatsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin | Marburg | 35043 | Germany |
| University Hospital Regensburg | Regensburg | 93053 | Germany |
| Universitaetsklinikum in Tubingen | Tübingen | 72076 | Germany |
| National Institute of Oncology | Budapest | 01122 | Hungary |
| Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika | Debrecen | 04032 | Hungary |
| Szte Borgyogyszati Es Allergologiai Klinika | Szeged | 06720 | Hungary |
| Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari | Bari | 70124 | Italy |
| Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo | Candiolo | 10060 | Italy |
| Irccs Azienda Ospedaliera Universitaria San Martino | Genova | 16132 | Italy |
| Fondazione Irccs Istituto Nazionale Dei Tumori | Milan | 20133 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| A.O.U. Di Modena - Policlinico | Modena | 41124 | Italy |
| Istituto Nazionale Tumori Irccs Fondazione Pascale | Naples | 80131 | Italy |
| Iov - Istituto Oncologico Veneto Irccs | Padova | 35128 | Italy |
| ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA | Rome | 00167 | Italy |
| Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte | Siena | 53100 | Italy |
| Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie | Warsaw | 02-781 | Poland |
| Hospital General Universitario Vall D Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Centre Hospitalier Universitaire Vaudois (Chuv) | Lausanne | 01011 | Switzerland |
| Universitatsspital Zurich | Zurich | 08091 | Switzerland |
| Castle Hill Hospital | Cottingham | HU16 5JQ | United Kingdom |
| Royal Free London Nhs Foundation Trust | London | NW3 2QG | United Kingdom |
| The Royal Marsden Nhs Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Royal Marsden Nhs Foundation Trust - Sutton | Sutton | SM2 5PT | United Kingdom |
| Royal Cornwall Hospital Truro Sunrise Centre | Truro | TR1 3LJ | United Kingdom |
| Chemotherapy: Refractory |
Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W. |
| Safety Evaluable Population |
|
| Enrolled Population |
|
| Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline data were collected in members of the Safety Evaluable Population, comprised of all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy: Naïve | Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W). |
| BG001 | Chemotherapy: Refractory | Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set (FAS): all participants enrolled in the study who received at least 1 dose of study drug as of 15 October 2020 (selected to allow for at least 60 chemotherapy-naïve participants to be followed for at least 6 months after first response assessment). Analysis was based on the chemotherapy-naïve subset of the FAS. Confidence intervals (CIs) were calculated based on the exact method for binomial distributions. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Safety Evaluable Population: all enrolled participants who received at least 1 dose of study drug. Analysis was based on the chemotherapy-naïve subset of the population. Only those participants who had confirmed CR or PR prior to PD or start of new anticancer therapy were assessed. The 95% CI was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation. | Posted | Number | 95% Confidence Interval | months | up to 55.3 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. | Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. CIs were calculated based on the exact method for binomial distributions. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 57.1 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). | Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median PFS time was estimated using the Kaplan-Meier method. The CI for median PFS time was calculated using the method of Brookmeyer and Crowley. | Posted | Median | 95% Confidence Interval | months | up to 57.1 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. | Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median overall survival time was estimated using the Kaplan-Meier method. CI for median overall survival time was calculated using the method of Brookmeyer and Crowley. | Posted | Median | 95% Confidence Interval | months | up to 60.4 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. | Safety Evaluable Population | Posted | Count of Participants | Participants | up to 846 days (up to approximately 2.3 years) |
| |||||||||||||||||||||||||||||||
| Secondary | First-dose Cmax of Retifanlimab | Cmax was defined as the maximum observed plasma concentration. | Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and have provided a Baseline and at least 1 post-dose PK sample | Posted | Mean | Standard Deviation | micrograms per milliliter (μg/mL) | 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. | PK Evaluable Population | Posted | Mean | Standard Deviation | μg/mL | 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. | PK Evaluable Population | Posted | Mean | Standard Deviation | day*mg/L | preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1 |
|
|
Deaths were assessed for up to 60.4 months. Adverse events were assessed for up to 846 days (up to approximately 2.3 years).
Treatment-emergent adverse events (TEAEs), defined as either AEs reported for the first time or worsening of pre-existing events after the first dose of study drug until 90 days after the last dose of study drug, are reported for members of the Safety Evaluable Population (all enrolled participants who received at least 1 dose of study drug). AEs with onset on/after starting a new anticancer therapy were not summarized as TEAEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy: Naïve | Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W). | 39 | 101 | 26 | 101 | 83 | 101 |
| EG001 | Chemotherapy: Refractory | Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W. | 3 | 6 | 2 | 6 | 5 | 6 |
| EG002 | Total | Total | 42 | 107 | 28 | 107 | 88 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Concomitant disease progression | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ductal adenocarcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Eosinophilic fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2021 | Apr 7, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015266 | Carcinoma, Merkel Cell |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W. |
|
|
Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|