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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04472429




Registration number
NCT04472429
Ethics application status
Date submitted
13/07/2020
Date registered
15/07/2020

Titles & IDs
Public title
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Scientific 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)
Secondary ID [1] 0 0
INCMGA 0012-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Anal Canal 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel
Treatment: Drugs - retifanlimab

Placebo comparator: Group A : carboplatin+paclitaxel+placebo - Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle

Experimental: Group B : carboplatin+paclitaxel+retifanlimab - Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle


Treatment: Drugs: carboplatin
carboplatin will be administered intravenous on Day 1 of each 28 day cycle

Treatment: Drugs: paclitaxel
paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle

Treatment: Drugs: retifanlimab
retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
up to 4.5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 4.5 years
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to 4.5 years
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to 4.5 years
Secondary outcome [4] 0 0
Disease Control Rate(DCR)
Timepoint [4] 0 0
Up to 4.5 years
Secondary outcome [5] 0 0
Number of treatment-emergent adverse events
Timepoint [5] 0 0
Up to 4.5 years
Secondary outcome [6] 0 0
Cmax of retifanlimab when administered with chemotherapy
Timepoint [6] 0 0
Up to 4.5 years
Secondary outcome [7] 0 0
tmax of retifanlimab when administered with chemotherapy
Timepoint [7] 0 0
Up to 4.5 years
Secondary outcome [8] 0 0
Cmin of retifanlimab when administered with chemotherapy
Timepoint [8] 0 0
Up to 4.5 years
Secondary outcome [9] 0 0
AUC0-t of retifanlimab when administered with chemotherapy
Timepoint [9] 0 0
Up to 4.5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2024
Actual
Sample size
Target
Accrual to date
Final
308
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital Australia - Woolloongabba
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment postcode(s) [1] 0 0
04102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
03168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Louisiana
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United States of America
State/province [5] 0 0
Maryland
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United States of America
State/province [6] 0 0
Minnesota
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United States of America
State/province [7] 0 0
Texas
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United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Bruxelles
Country [11] 0 0
Denmark
State/province [11] 0 0
Herlev
Country [12] 0 0
Denmark
State/province [12] 0 0
Vejle
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France
State/province [13] 0 0
Angers Cedex 2
Country [14] 0 0
France
State/province [14] 0 0
Besançon
Country [15] 0 0
France
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Bordeaux Cedex
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France
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Lyon
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France
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Marseille Cedex 5
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France
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Montpellier
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France
State/province [19] 0 0
Nice
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France
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Paris Cedex 13
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France
State/province [21] 0 0
Poitiers Cedex
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France
State/province [22] 0 0
Rennes Cedex 09
Country [23] 0 0
France
State/province [23] 0 0
Rouen Cedex
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France
State/province [24] 0 0
Saint Herblain
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France
State/province [25] 0 0
Strasbourg
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France
State/province [26] 0 0
Toulouse Cedex 9
Country [27] 0 0
France
State/province [27] 0 0
Villejuif Cedex
Country [28] 0 0
Germany
State/province [28] 0 0
Bonn
Country [29] 0 0
Germany
State/province [29] 0 0
Dresden
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Milan
Country [33] 0 0
Italy
State/province [33] 0 0
Monserrato
Country [34] 0 0
Italy
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Napoli
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Italy
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Padova
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Italy
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Pisa
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Italy
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Rimini
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Italy
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San Giovanni Rotondo
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Italy
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Torrette
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Japan
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Chuo-ku
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Japan
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Fukuoka-shi
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Japan
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Hidaka-shi
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Japan
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Nagoya-shi
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Japan
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Osaka-shi
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Japan
State/province [45] 0 0
Sendai-shi
Country [46] 0 0
Japan
State/province [46] 0 0
Shinjuku-ku
Country [47] 0 0
Norway
State/province [47] 0 0
Bergen
Country [48] 0 0
Norway
State/province [48] 0 0
Oslo
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Puerto Rico
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San Juan
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Palma de Mallorca
Country [54] 0 0
Spain
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Sevilla
Country [55] 0 0
Spain
State/province [55] 0 0
Zaragoza
Country [56] 0 0
Sweden
State/province [56] 0 0
Goteborg
Country [57] 0 0
Sweden
State/province [57] 0 0
Lund
Country [58] 0 0
Sweden
State/province [58] 0 0
Stockholm
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Brighton
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cambridge
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Guildford
Country [62] 0 0
United Kingdom
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Hull
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Leeds
Country [64] 0 0
United Kingdom
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London
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United Kingdom
State/province [65] 0 0
Manchester
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United Kingdom
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Oxford
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United Kingdom
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Preston
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Sutton
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United Kingdom
State/province [69] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04472429