Back to resultsCarboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Primary Purpose
Squamous Cell Carcinoma of the Anal Canal
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboplatin
paclitaxel
retifanlimab
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Anal Canal focused on measuring Squamous cell carcinoma, carboplatin, paclitaxel, PD-1 Inhibitor, Anal Cancer, SCAC
Eligibility Criteria
Inclusion Criteria:
Able to comprehend and willing to sign a written ICF for the study.
- Are 18 years of age or older (or as applicable per local country requirements).
- Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC.
No prior systemic therapy other than the following: a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent is permitted.
b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study entry.
- Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion.
- Able and willing to provide adequate tissue sample and whole blood sample with central testing result prior to randomization. Biopsy for archival samples should have occurred within 9 months prior to randomization.
- ECOG performance status 0 to 1.
- If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 200/μL, b. Undetectable viral load per standard of care assay, c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment.
- Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
- Has received prior PD-(L)1 directed therapy
- Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1).
- Participants with laboratory outside of the protocol defined ranges.
- History of second malignancy within 3 years (with exceptions).
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C and IV antibiotic use within 7 days of Cycle 1 Day 1.
- Receipt of a live vaccine within 28 days of planned start of study therapy.
- History of organ transplant, including allogeneic stem cell transplantation.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids).
- Participant is pregnant or breastfeeding.
- Current use of protocol defined prohibited medication.
- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.
- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements
Sites / Locations
- The University of Arizona Cancer Center
- City of Hope National Medical Center
- UC Davis Comprehensive Cancer Center
- Sansum Clinic
- Rocky Mountain Cancer Center
- Ochsner Clinic
- Maryland Oncology Hematology, P.A.
- Mayo Clinic
- Texas Oncology
- Baylor Scott and White Research Institute
- Renovatio Clinical Consultants Llc
- Texas Oncology-Wichita Falls Texoma Cancer Center
- Virginia Cancer Specialists, Pc
- Blue Ridge Cancer Care
- Princess Alexandra Hospital Australia
- Flinders Medical Centre
- Monash Medical Centre Clayton
- Zna Middelheim
- Ulb Hospital Erasme
- Herlev Og Gentofte Hospital
- Vejle Hospital
- Institut de Cancerologie de L Ouest - Site Paul Papin
- Chu Besancon Hospital Jean Minjoz
- Centre Hospitalier Universitaire de Bordeaux
- Centre Leon Berard
- Chu Hopital de La Timone
- Institut Du Cancer de Montpellier
- Centre Antoine Laccassagne
- Hospital Universitaire Pitie-Salpetriere
- Hospital de La Miletrie
- Chu de Rennes - Hospital Pontchaillou
- Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
- Institut de Cancerologie de Strasbourg
- Chu Toulouse Hopital Rangueil
- Institut Gustave Roussy
- Universitatsklinikum Bonn Aoer
- University Clinic Carl Gustav Carus Technical University Dresden
- Asklepios Klinik Altona
- Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
- European Institute of Oncology
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
- Fondazione Irccs Ca Granda Ospedale Maggiore
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
- University Di Cagliari-Presidio Policlinico Monserrato
- Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
- Iov - Istituto Oncologico Veneto Irccs
- Azienda Ospedaliero Universitaria Pisana
- Ospedale Degli Infermi
- I.R.C.C.S. Casa Sollievo Della Sofferenza
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- National Cancer Center Hospital
- Kyushu University Hospital
- Saitama Medical University International Medical Center
- Aichi Cancer Center Hospital
- Osaka International Cancer Institute
- Tohoku University Hospital
- Center Hospital of the National Center For Global Health and Medicine
- Haukeland University Hospital
- Oslo Universitetssykehus
- Panoncology Trials Pan American Center For Oncology Trials, Llc
- Complejo Hospitalario Universitario A Coruna
- Hospital General Universitario Vall D Hebron
- Hospital Clinic de Barcelona
- Hospital Universitario 12 de Octubre
- Hospital Universitario de La Paz
- Son Espases University Hospital
- Hospital Universitario Virgen Del Rocio
- Hospital Universitario Miguel Servet
- Sahlgrenska University Hospital
- Skaenes Universitetssjukhus Lund
- Stockholm South General Hospital Sodersjukhuset
- Royal Sussex County Hospital
- Addenbrooke'S Hospital
- Royal Surrey County Hospital
- Castle Hill Hospital
- Leeds Teaching Hospital
- Royal Free London Nhs Foundation Trust
- The Royal Marsden Nhs Foundation Trust - Chelsea
- The Christie Nhs Foundation Trust Uk
- Churchill Hospital
- Royal Preston Hospital
- The Royal Marsden Nhs Foundation Trust - Sutton
- Royal Cornwall Hospital Truro Sunrise Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Group A : carboplatin+paclitaxel+placebo
Group B : carboplatin+paclitaxel+retifanlimab
Arm Description
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
Defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death due to any cause.
Secondary Outcome Measures
Overall Survival (OS)
Defined as the time from the date of randomization until death due to any cause.
Overall Response Rate (ORR)
Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.
Duration of Response (DOR)
Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.
Disease Control Rate(DCR)
Defined as the number of participants maintaining either an ORR or stable disease.
Number of treatment-emergent adverse events
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.
Cmax of retifanlimab when administered with chemotherapy
Maximum observed plasma or serum concentration.
tmax of retifanlimab when administered with chemotherapy
Time to maximum concentration
Cmin of retifanlimab when administered with chemotherapy
Minimum observed plasma or serum concentration over the dose interval
AUC0-t of retifanlimab when administered with chemotherapy
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04472429
Brief Title
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Official Title
A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
October 24, 2024 (Anticipated)
Study Completion Date
October 27, 2024 (Anticipated)
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
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Anal Canal
Keywords
Squamous cell carcinoma, carboplatin, paclitaxel, PD-1 Inhibitor, Anal Cancer, SCAC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A : carboplatin+paclitaxel+placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
Arm Title
Group B : carboplatin+paclitaxel+retifanlimab
Arm Type
Experimental
Arm Description
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
carboplatin will be administered intravenous on Day 1 of each 28 day cycle
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
Intervention Type
Drug
Intervention Name(s)
retifanlimab
Other Intervention Name(s)
INCMGA00012
Intervention Description
retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death due to any cause.
Time Frame
up to 4.5 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Defined as the time from the date of randomization until death due to any cause.
Time Frame
Up to 4.5 years
Title
Overall Response Rate (ORR)
Description
Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.
Time Frame
Up to 4.5 years
Title
Duration of Response (DOR)
Description
Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.
Time Frame
Up to 4.5 years
Title
Disease Control Rate(DCR)
Description
Defined as the number of participants maintaining either an ORR or stable disease.
Time Frame
Up to 4.5 years
Title
Number of treatment-emergent adverse events
Description
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.
Time Frame
Up to 4.5 years
Title
Cmax of retifanlimab when administered with chemotherapy
Description
Maximum observed plasma or serum concentration.
Time Frame
Up to 4.5 years
Title
tmax of retifanlimab when administered with chemotherapy
Description
Time to maximum concentration
Time Frame
Up to 4.5 years
Title
Cmin of retifanlimab when administered with chemotherapy
Description
Minimum observed plasma or serum concentration over the dose interval
Time Frame
Up to 4.5 years
Title
AUC0-t of retifanlimab when administered with chemotherapy
Description
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t
Time Frame
Up to 4.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to comprehend and willing to sign a written ICF for the study.
Are 18 years of age or older (or as applicable per local country requirements).
Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC.
No prior systemic therapy other than the following: a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent is permitted.
b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study entry.
Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion.
Able and willing to provide adequate tissue sample and whole blood sample with central testing result prior to randomization. Biopsy for archival samples should have occurred within 9 months prior to randomization.
ECOG performance status 0 to 1.
If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 200/μL, b. Undetectable viral load per standard of care assay, c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment.
Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
Has received prior PD-(L)1 directed therapy
Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1).
Participants with laboratory outside of the protocol defined ranges.
History of second malignancy within 3 years (with exceptions).
Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
Active bacterial, fungal, or viral infections, including hepatitis A, B, and C and IV antibiotic use within 7 days of Cycle 1 Day 1.
Receipt of a live vaccine within 28 days of planned start of study therapy.
History of organ transplant, including allogeneic stem cell transplantation.
Known active CNS metastases and/or carcinomatous meningitis.
Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids).
Participant is pregnant or breastfeeding.
Current use of protocol defined prohibited medication.
Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.
Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements
Facility Information:
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
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
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Texas Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Baylor Scott and White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Renovatio Clinical Consultants Llc
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology-Wichita Falls Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Virginia Cancer Specialists, Pc
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Princess Alexandra Hospital Australia
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
04102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Monash Medical Centre Clayton
City
Clayton
State/Province
Victoria
ZIP/Postal Code
03168
Country
Australia
Facility Name
Zna Middelheim
City
Antwerpen
ZIP/Postal Code
02020
Country
Belgium
Facility Name
Ulb Hospital Erasme
City
Bruxelles
ZIP/Postal Code
01070
Country
Belgium
Facility Name
Herlev Og Gentofte Hospital
City
Herlev
ZIP/Postal Code
02730
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
07100
Country
Denmark
Facility Name
Institut de Cancerologie de L Ouest - Site Paul Papin
City
Angers Cedex 2
ZIP/Postal Code
49055
Country
France
Facility Name
Chu Besancon Hospital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Chu Hopital de La Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Institut Du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Laccassagne
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hospital Universitaire Pitie-Salpetriere
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Hospital de La Miletrie
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Chu de Rennes - Hospital Pontchaillou
City
Rennes Cedex 09
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Institut de Cancerologie de Strasbourg
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Chu Toulouse Hopital Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Universitatsklinikum Bonn Aoer
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
University Clinic Carl Gustav Carus Technical University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione Irccs Ca Granda Ospedale Maggiore
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
University Di Cagliari-Presidio Policlinico Monserrato
City
Monserrato
ZIP/Postal Code
09042
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Iov - Istituto Oncologico Veneto Irccs
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale Degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
I.R.C.C.S. Casa Sollievo Della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Torrette
ZIP/Postal Code
60020
Country
Italy
Facility Name
National Cancer Center Hospital
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-shi
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Center Hospital of the National Center For Global Health and Medicine
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
05021
Country
Norway
Facility Name
Oslo Universitetssykehus
City
Oslo
ZIP/Postal Code
00450
Country
Norway
Facility Name
Panoncology Trials Pan American Center For Oncology Trials, Llc
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
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
Hospital Universitario de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Son Espases University Hospital
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skaenes Universitetssjukhus Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Stockholm South General Hospital Sodersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Addenbrooke'S Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Leeds Teaching Hospital
City
Leeds
ZIP/Postal Code
LS 9 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 6JJ
Country
United Kingdom
Facility Name
The Christie Nhs Foundation Trust Uk
City
Manchester
ZIP/Postal Code
M20 4BV
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
The Royal Marsden Nhs Foundation Trust - Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Cornwall Hospital Truro Sunrise Centre
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Citations:
PubMed Identifier
36091159
Citation
Rao S, Jones M, Bowman J, Tian C, Spano JP. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.
Results Reference
derived
Learn more about this trial
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
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