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A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

Primary Purpose

Squamous Cell Carcinoma of Anal Canal

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Retifanlimab
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Anal Canal focused on measuring Squamous carcinoma of the anal canal, anti-PD-1 antibody, IgG4 monoclonal antibody, INCMGA00012

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to comprehend and willingness to sign a written informed consent form.
  • Confirmed diagnosis of locally advanced or metastatic SCAC.
  • Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
  • Must have measurable disease by RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

Exclusion Criteria:

  • Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
  • 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.
  • Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
  • Active autoimmune disease requiring systemic immunosuppression.
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Known active hepatitis infection.
  • Active infections requiring systemic therapy.
  • Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.

Sites / Locations

  • City of Hope National Medical Center
  • UC Davis Comprehensive Cancer Center
  • Ridley-Tree Cancer Center
  • Maryland Oncology Hematology P.A.
  • Texas Oncology-Baylor Charles A. Sammons
  • Texas Oncology-McKinney
  • Renovatio Clinical
  • Zna Middelheim
  • Hopital Erasme
  • Aarhus Universitets Hospital
  • Herlev Og Gentofte Hospital
  • Vejle Hospital
  • Centre Hospitalier Universitaire de Besancon
  • Chu Hopital de La Timone
  • CHU Hopital De La Timone
  • Icm Montpellier
  • Hopital Universitaire Pitie-Salpetriere
  • Chu de Rennes - Hôpital Pontchaillou
  • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
  • CHU Toulouse Hopital Rangueil
  • University Medical Centre Hamburg-Eppendorf, Centre of Oncology
  • Asklepios Klinik Altona
  • Azienda Ospedaliero Universitaria Ospedali Riuniti
  • Ospedale A. Perrino - Brindisi
  • A.O.U. Policlinico V. Emanuele G. Rodolico
  • Ospedale Degli Infermi - Faenza
  • Irccs Azienda Ospedaliera Universitaria San Martino
  • Niguarda Cancer Center
  • Aou Modena - Policlinico
  • Clinica La Maddalena
  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
  • IRCCS Casa Sollievo Della Sofferenza
  • Haukeland U Hospital Bergen
  • Oslo U
  • Hospital General Universitari Vall D Hebron
  • Hospital Clinic I Provincial
  • Hospital Universitario 12 de Octubre
  • Royal Sussex County Hospital
  • Royal Marsden Hospital
  • Castle Hill Hospital
  • St. James U Hospital
  • St. James Univ Hospital
  • Royal Free London Nhs Foundation Trust
  • The Royal Marsden Nhs Foundation Trust - Chelsea
  • The Christie NHS Foundation Trust
  • Royal Marsden Hospital
  • Royal Cornwall Hospital, Sunrise Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retifanlimab 500 mg

Arm Description

Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Outcomes

Primary Outcome Measures

Objective 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 assessed by independent central radiographic (ICR) review, 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.

Secondary Outcome Measures

Duration of Response (DOR)
DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, 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.
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, 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 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.
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, as determined by ICR, or death due to any cause, if occurring sooner than progression.
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.
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 have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the 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 within 90 days of the last administration of retifanlimab.
Cmax of Retifanlimab
Cmax was defined as the maximum observed plasma concentration.
Tmax of Retifanlimab
tmax was defined as the time to the maximum concentration.
Cmin of Retifanlimab
Cmin was defined as the minimum observed plasma concentration over the dose interval.
AUC0-t of Retifanlimab
AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Full Information

First Posted
July 16, 2018
Last Updated
October 24, 2022
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03597295
Brief Title
A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
Official Title
A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
June 8, 2020 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Anal Canal
Keywords
Squamous carcinoma of the anal canal, anti-PD-1 antibody, IgG4 monoclonal antibody, INCMGA00012

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retifanlimab 500 mg
Arm Type
Experimental
Arm Description
Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Intervention Type
Drug
Intervention Name(s)
Retifanlimab
Other Intervention Name(s)
MGA012, INCMGA00012
Intervention Description
Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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 assessed by independent central radiographic (ICR) review, 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.
Time Frame
Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, 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.
Time Frame
up to 18.2 months
Title
Disease Control Rate (DCR)
Description
DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, 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 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.
Time Frame
Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
Title
Progression-free Survival (PFS)
Description
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, as determined by ICR, or death due to any cause, if occurring sooner than progression.
Time Frame
up to 16.8 months
Title
Overall Survival
Description
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.
Time Frame
up to 28.2 months
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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 have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the 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 within 90 days of the last administration of retifanlimab.
Time Frame
up to 913 days
Title
Cmax of Retifanlimab
Description
Cmax was defined as the maximum observed plasma concentration.
Time Frame
pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
Title
Tmax of Retifanlimab
Description
tmax was defined as the time to the maximum concentration.
Time Frame
pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
Title
Cmin of Retifanlimab
Description
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Time Frame
pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
Title
AUC0-t of Retifanlimab
Description
AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Time Frame
pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to comprehend and willingness to sign a written informed consent form. Confirmed diagnosis of locally advanced or metastatic SCAC. Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments. Must have measurable disease by RECIST v1.1. Eastern Cooperative Oncology Group performance status of 0 to 1. If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy. Exclusion Criteria: Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C. 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. Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy. Active autoimmune disease requiring systemic immunosuppression. Known central nervous system (CNS) metastases and/or carcinomatous meningitis. Known active hepatitis infection. Active infections requiring systemic therapy. Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Ridley-Tree Cancer Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Maryland Oncology Hematology P.A.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology-McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Renovatio Clinical
City
Spring
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Zna Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Aarhus Universitets Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Herlev Og Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Centre Hospitalier Universitaire de Besancon
City
Besancon
ZIP/Postal Code
2500
Country
France
Facility Name
Chu Hopital de La Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Hopital De La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Icm Montpellier
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Universitaire Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Chu de Rennes - Hôpital Pontchaillou
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
CHU Toulouse Hopital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University Medical Centre Hamburg-Eppendorf, Centre of Oncology
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Ospedale A. Perrino - Brindisi
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
A.O.U. Policlinico V. Emanuele G. Rodolico
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Ospedale Degli Infermi - Faenza
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Irccs Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Niguarda Cancer Center
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Aou Modena - Policlinico
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Clinica La Maddalena
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS Casa Sollievo Della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Haukeland U Hospital Bergen
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo U
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Hospital General Universitari Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Chelsea
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
St. James U Hospital
City
Leeds
ZIP/Postal Code
L59 7TF
Country
United Kingdom
Facility Name
St. James Univ Hospital
City
Leeds
ZIP/Postal Code
L59 7TF
Country
United Kingdom
Facility Name
Royal Free London Nhs Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Royal Marsden Nhs Foundation Trust - Chelsea
City
London
ZIP/Postal Code
SW3 6JI
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BV
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Cornwall Hospital, Sunrise Centre
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35816951
Citation
Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, Saunders MP, Gilbert DC, Jensen LH, Samalin E, Spindler KL, Tamberi S, Demols A, Guren MG, Arnold D, Fakih M, Kayyal T, Cornfeld M, Tian C, Catlett M, Smith M, Spano JP. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529. doi: 10.1016/j.esmoop.2022.100529. Epub 2022 Jul 8.
Results Reference
result

Learn more about this trial

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

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