A Study of INCMGA00012 in Participants With Selected Soli... | NCT03679767 | Trialant
NCT03679767
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Jul 21, 2023Actual
Enrollment
121Actual
Phase
Phase 2
Conditions
Metastatic Non-small Cell Lung Cancer
Locally Advanced Urothelial Cancer
Metastatic Urothelial Cancer
Unresectable Melanoma
Metastatic Melanoma
Locally Advanced Renal Cell Carcinoma
Metastatic Clear-Cell Renal Cell Carcinoma
Interventions
Retifanlimab
Countries
United States
Austria
France
Hungary
Italy
Poland
Romania
Spain
Protocol Section
Identification Module
NCT ID
NCT03679767
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCMGA 0012-203
Secondary IDs
Not provided
Brief Title
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
Official Title
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 9, 2019Actual
Primary Completion Date
Apr 15, 2021Actual
Completion Date
Jun 28, 2022Actual
First Submitted Date
Sep 19, 2018
First Submission Date that Met QC Criteria
Sep 19, 2018
First Posted Date
Sep 20, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Apr 13, 2022
Results First Submitted that Met QC Criteria
Apr 13, 2022
Results First Posted Date
May 10, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 13, 2023
Last Update Posted Date
Jul 21, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.
Detailed Description
Not provided
Conditions Module
Conditions
Metastatic Non-small Cell Lung Cancer
Locally Advanced Urothelial Cancer
Metastatic Urothelial Cancer
Unresectable Melanoma
Metastatic Melanoma
Locally Advanced Renal Cell Carcinoma
Metastatic Clear-Cell Renal Cell Carcinoma
Keywords
PD-1inhibitor
non-small cell lung cancer
urothelial cancer
melanoma
renal cell carcinoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
121Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Melanoma: retifanlimab 500 mg
Experimental
Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle.
Drug: Retifanlimab
NSCLC: retifanlimab 500 mg
Experimental
Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
Drug: Retifanlimab
UC: retifanlimab 500 mg
Experimental
Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
Drug: Retifanlimab
RCC: retifanlimab 500 mg
Experimental
Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
Drug: Retifanlimab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Retifanlimab
Drug
Retifanlimab administered intravenously at 500 mg every 4 weeks
Melanoma: retifanlimab 500 mg
NSCLC: retifanlimab 500 mg
RCC: retifanlimab 500 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a best 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 the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. 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 25.9 months
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DOR)
DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, or death due to any cause. 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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy.
Measurable disease per RECIST v1.1.
Eastern Cooperative Oncology Group performance status 0 to 1.
Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is > 30 Gy.
Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
Has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
Laboratory values outside the protocol-defined range at screening.
Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry.
Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
Evidence of interstitial lung disease or active noninfectious pneumonitis.
Known active central nervous system metastases and/or carcinomatous meningitis.
Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.
Active infections requiring systemic therapy.
Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥ 300/μL, undetectable viral load, receiving antiretroviral therapy.
Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
Impaired cardiac function or clinically significant cardiac disease.
Is pregnant or breastfeeding.
Has received a live vaccine within 28 days of the planned start of study drug.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Mark Cornfeld, MD
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
California Cancer Associates for Research and Excellence, Inc.
Fresno
California
93720
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 121 participants with advanced solid tumors (melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma) were enrolled in the study and treated with retifanlimab.
Recruitment Details
This study was conducted at 34 study centers in Austria, Spain, France, Hungary, Italy, Poland, Romania, and the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
FG001
Non-small Cell Lung Cancer
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 23, 2021
Apr 13, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
UC: retifanlimab 500 mg
INCMGA00012
up to 24.0 months
Disease Control Rate (DCR)
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. 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 25.9 months
Progression-free Survival (PFS)
According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, determined by investigator assessment, or death due to any cause, if occurring sooner than progression.
up to 25.9 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 28.2 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
up to approximately 2.3 years
First-dose Cmax of Retifanlimab
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
Cmax of Retifanlimab at Steady-state
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
First-dose Tmax of Retifanlimab
tmax was defined as the time to the maximum concentration of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
Tmax of Retifanlimab at Steady-state
tmax was defined as the time to the maximum concentration of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
First-dose Cmin of Retifanlimab
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
Cmin of Retifanlimabv at Steady-state
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
First-dose AUC0-t of Retifanlimab
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
AUC0-t of Retifanlimab at Steady-state
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
California Cancer Associates for Research and Excellence
Fresno
California
93720
United States
California Cancer Associates for Research and Excellence, Inc.
San Marcos
California
92069
United States
St Joseph Heritage Healthcare
Santa Rosa
California
95403
United States
St. Joseph Health Medical Group - Annadel Medical Group
Santa Rosa
California
95403
United States
Rocky Mountain Cancer Centers - Denver - Midtown
Denver
Colorado
80218
United States
Christiana Care Helen F. Graham Cancer Center
Newark
Delaware
19718
United States
Rcca Md, Llc
Bethesda
Maryland
20817
United States
VA New Jersey Health Care System
East Orange
New Jersey
07018
United States
New York Oncology Hematology - Albany
Albany
New York
12208
United States
Kaiser Permanente
Portland
Oregon
97227
United States
Texas Oncology Surgical Specialists - Austin Central
Austin
Texas
78731
United States
Coastal Bend Cancer Center
Corpus Christi
Texas
78404
United States
AIM Trials, LLC
Plano
Texas
75093
United States
Texas Oncology - San Antonio Northeast
San Antonio
Texas
78217
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
The Woodlands
Texas
77380
United States
Texas Oncology - Waco
Waco
Texas
76712
United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona
Ancona
60126
Italy
ASST Istituti Ospitalieri
Cremona
26100
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
47014
Italy
Istituto Nazionale Tumori Regina Elena
Rome
00144
Italy
Azienda Ospedaliera Universitaria Senese
Siena
53100
Italy
Med-Polonia Sp. z o. o.
Poznan
Greater Poland Voivodeship
Poland
Centrum Onkologii- Instytut im Marii Skłodowskiej Curie
Warsaw
Masovian Voivodeship
Poland
Specjalistyczna Praktyka Lekarska
Lublin
20-093
Poland
BioVirtus Research Site
Otwock
05-400
Poland
Centrul de Oncologie Sfantul Nectarie
Craiova
Dolj
200347
Romania
Oncolab SRL
Craiova
Dolj
200385
Romania
Medisprof SRL
Cluj-Napoca
400461
Romania
Clinical Emergency Hospital of Constanta
Constanța
900591
Romania
Center of Oncology Euroclinic
Iași
700106
Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu
550245
Romania
Oncocenter - Oncologie Clinica SRL
Timișoara
300166
Romania
Hospital Universitari Parc Tauli
Sabadell
Barcelona
08208
Spain
Centro Oncologico De Galicia
A Coruña
08041
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
08025
Spain
Hospital Universitario Vall d'Hebron
Barcelona
08025
Spain
MD Anderson Cancer Center Madrid
Madrid
28033
Spain
Hospital Puerta De Hierro
Majadahonda
28220
Spain
Hospital Universitari La Fe
Valencia
46026
Spain
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
FG002
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
FG003
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
FG00035 subjects
FG00123 subjects
FG00229 subjects
FG00334 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00035 subjects
FG00123 subjects
FG00229 subjects
FG00334 subjects
Type
Comment
Reasons
Death
FG00016 subjects
FG00111 subjects
FG00217 subjects
FG00310 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Follow-up Completed
FG00018 subjects
FG00111 subjects
FG00211 subjects
FG00320 subjects
Entered Hospice Care
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
BG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
BG002
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
BG003
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00123
BG00229
BG00334
BG004121
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00067.2± 15.24
BG00167.8± 8.68
BG00272.0± 8.23
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG0017
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG00035
BG00122
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0004
BG0010
BG002
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
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a best 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 the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. 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) Population: all study participants who had received at least 1 dose of study drug. Participants were to be analyzed based on disease-specific diagnosis. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
up to 25.9 months
ID
Title
Description
OG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
OG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG002
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG003
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG00035
OG00123
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG00040.0(23.9 to 57.9)
OG00134.8(16.4 to 57.3)
OG00237.9(20.7 to 57.7)
OG003
Secondary
Duration of Response (DOR)
DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, or death due to any cause. 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.
FAS Population. Only those participants with a CR or PR were included in the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
Posted
Median
95% Confidence Interval
months
up to 24.0 months
ID
Title
Description
OG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
OG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Secondary
Disease Control Rate (DCR)
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. 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.
FAS Population. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
up to 25.9 months
ID
Title
Description
OG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
OG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG002
Urethelial Carcinoma
Secondary
Progression-free Survival (PFS)
According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, determined by investigator assessment, or death due to any cause, if occurring sooner than progression.
FAS Population. Median PFS was estimated using the Kaplan-Meier method. The confidence interval for median PFS was calculated using the method of Brookmeyer and Crowley.
Posted
Median
95% Confidence Interval
months
up to 25.9 months
ID
Title
Description
OG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
OG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG002
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG003
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.
FAS Population. Median survival time in months was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Posted
Median
95% Confidence Interval
months
up to 28.2 months
ID
Title
Description
OG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
OG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG002
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG003
Renal Cell Carcinoma
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
Safety Evaluable Population: all participants who received at least 1 dose of study drug
Posted
Count of Participants
Participants
up to approximately 2.3 years
ID
Title
Description
OG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
OG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG002
Urethelial Carcinoma
Secondary
First-dose Cmax of Retifanlimab
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and provided a Baseline and at least 1 postdose PK sample
Posted
Mean
Standard Deviation
milligrams per Liter (mg/L)
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000
Secondary
Cmax of Retifanlimab at Steady-state
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
PK Evaluable Population
Posted
Mean
Standard Deviation
mg/L
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000
Secondary
First-dose Tmax of Retifanlimab
tmax was defined as the time to the maximum concentration of retifanlimab.
PK Evaluable Population
Posted
Median
Full Range
hours
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000121
Secondary
Tmax of Retifanlimab at Steady-state
tmax was defined as the time to the maximum concentration of retifanlimab.
PK Evaluable Population
Posted
Median
Full Range
hours
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000
Secondary
First-dose Cmin of Retifanlimab
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
PK Evaluable Population
Posted
Mean
Standard Deviation
mg/L
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000
Secondary
Cmin of Retifanlimabv at Steady-state
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
PK Evaluable Population
Posted
Mean
Standard Deviation
mg/L
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000
Secondary
First-dose AUC0-t of Retifanlimab
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
PK Evaluable Population
Posted
Mean
Standard Deviation
day*mg/L
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000
Secondary
AUC0-t of Retifanlimab at Steady-state
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
PK Evaluable Population
Posted
Mean
Standard Deviation
day*mg/L
preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
ID
Title
Description
OG000
All Participants
Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG000
Time Frame
Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Description
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
16
35
8
35
30
35
EG001
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
11
23
9
23
19
23
EG002
Urothelial Cancer
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
17
29
12
29
25
29
EG003
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10
34
11
34
30
34
EG004
Total
Total
54
121
40
121
104
121
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG0030 events0 affected34 at risk
EG0041 events1 affected121 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Arterial occlusive disease
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Chills
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0012 events2 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Hyperthermia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Orchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Paroxysmal atrioventricular block
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0013 events3 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events1 affected29 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0023 events3 affected29 at risk
EG0032 events1 affected34 at risk
EG0046 events5 affected121 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 events4 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0014 events3 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Amylase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0011 events1 affected23 at risk
EG0029 events9 affected29 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected35 at risk
EG0012 events2 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG00010 events8 affected35 at risk
EG0010 events0 affected23 at risk
EG00215 events8 affected29 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG00011 events7 affected35 at risk
EG0012 events2 affected23 at risk
EG00211 events9 affected29 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected35 at risk
EG0011 events1 affected23 at risk
EG0024 events4 affected29 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0013 events3 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected23 at risk
EG0025 events5 affected29 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Chills
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0024 events3 affected29 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected23 at risk
EG0029 events6 affected29 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 events4 affected35 at risk
EG0010 events0 affected23 at risk
EG0024 events1 affected29 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0004 events4 affected35 at risk
EG0015 events5 affected23 at risk
EG0028 events7 affected29 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00022 events7 affected35 at risk
EG0013 events3 affected23 at risk
EG0026 events5 affected29 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected35 at risk
EG0011 events1 affected23 at risk
EG0023 events2 affected29 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 events2 affected35 at risk
EG0013 events3 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0013 events3 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0007 events6 affected35 at risk
EG0012 events2 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0007 events7 affected35 at risk
EG0012 events1 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected23 at risk
EG0022 events1 affected29 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events1 affected23 at risk
EG0024 events3 affected29 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0005 events5 affected35 at risk
EG0011 events1 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Lipase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0011 events1 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 events5 affected35 at risk
EG0010 events0 affected23 at risk
EG0024 events4 affected29 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0023 events2 affected29 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected23 at risk
EG0025 events5 affected29 at risk
EG003
Pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0011 events1 affected23 at risk
EG0025 events3 affected29 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG00012 events9 affected35 at risk
EG0013 events3 affected23 at risk
EG0025 events4 affected29 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0006 events3 affected35 at risk
EG0012 events2 affected23 at risk
EG0027 events4 affected29 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG00012 events5 affected35 at risk
EG0012 events2 affected23 at risk
EG0023 events3 affected29 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0024 events2 affected29 at risk
EG003
Skin infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected35 at risk
EG0016 events5 affected23 at risk
EG0025 events4 affected29 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected29 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected29 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected35 at risk
EG0011 events1 affected23 at risk
EG0024 events2 affected29 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected29 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
66.6
± 10.28
BG00468.3± 11.36
4
BG00310
BG00441
Male
BG00015
BG00116
BG00225
BG00324
BG00480
20
BG00333
BG004110
Asian
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
Not Reported
Title
Measurements
BG0000
BG0010
BG0029
BG0031
BG00410
1
BG0030
BG0045
Not Hispanic or Latino
Title
Measurements
BG00030
BG00122
BG00212
BG00329
BG00493
Not Reported
Title
Measurements
BG0001
BG0011
BG00216
BG0035
BG00423
34
23.5
(10.7 to 41.2)
OG002
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG003
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG00014
OG0018
OG00211
OG0038
Title
Denominators
Categories
Title
Measurements
OG000NA(9.2 to NA)The median and upper limit of the confidence interval were not estimable because too few participants had events of disease progression or death.
OG00118.2(1.9 to NA)The upper limit of the confidence interval was not estimable because too few participants had events of disease progression or death.
OG00211.5(2.2 to NA)The upper limit of the confidence interval was not estimable because too few participants had events of disease progression or death.
OG003NA(2.8 to NA)The median and upper limit of the confidence interval were not estimable because too few participants had events of disease progression or death
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG003
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG00035
OG00123
OG00229
OG00334
Title
Denominators
Categories
Title
Measurements
OG00054.3(36.6 to 71.2)
OG00165.2(42.7 to 83.6)
OG00255.2(35.7 to 73.6)
OG00364.7(46.5 to 80.3)
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG00035
OG00123
OG00229
OG00334
Title
Denominators
Categories
Title
Measurements
OG0003.6(1.8 to NA)The upper limit of the confidence interval was not estimable because too few participants had events of disease progression or death.
OG0014.4(1.8 to 21.9)
OG0025.7(1.8 to 13.6)
OG0035.4(2.3 to 11.4)
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
Units
Counts
Participants
OG00035
OG00123
OG00229
OG00334
Title
Denominators
Categories
Title
Measurements
OG000NA(8.7 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had events of death.
OG00121.9(5.2 to NA)The upper limit of the confidence interval was not estimable because too few participants had events of death.
OG00215.2(7.7 to NA)The upper limit of the confidence interval was not estimable because too few participants had events of death.
OG003NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had events of death.
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
OG003
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.