Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date last updated
8/07/2025
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).
Query!
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)
Query!
Secondary ID [1]
0
0
2020-000826-24
Query!
Secondary ID [2]
0
0
INCMGA 0012-303
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Anal Canal
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [1]
0
0
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
Query!
Timepoint [1]
0
0
up to 33.9 months
Query!
Secondary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
Overall survival was defined as the time from the date of randomization until the date of death due to any cause.
Query!
Timepoint [1]
0
0
up to 40.4 months
Query!
Secondary outcome [2]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [2]
0
0
ORR was defined as the percentage of participants with a CR or PR at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. 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: 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.
Query!
Timepoint [2]
0
0
up to 445 days
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR)
Query!
Assessment method [3]
0
0
DOR was defined as the time from the first documented response (CR or PR) determined by BICR to the time of first documented disease progression per RECIST v1.1 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: 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.
Query!
Timepoint [3]
0
0
up to 32.1 months
Query!
Secondary outcome [4]
0
0
Disease Control Rate (DCR)
Query!
Assessment method [4]
0
0
DCR was defined as the percentage of participants maintaining either a confirmed overall response of CR or PR or stable disease (SD) at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. 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: 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.
Query!
Timepoint [4]
0
0
up to 445 days
Query!
Secondary outcome [5]
0
0
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period
Query!
Assessment method [5]
0
0
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 be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Query!
Timepoint [5]
0
0
up to 535 days
Query!
Secondary outcome [6]
0
0
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Randomized Period
Query!
Assessment method [6]
0
0
An 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 be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Query!
Timepoint [6]
0
0
up to 535 days
Query!
Secondary outcome [7]
0
0
Number of Participants With Any TEAE During the Open-label Monotherapy Period
Query!
Assessment method [7]
0
0
An 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 be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Query!
Timepoint [7]
0
0
up 457 days
Query!
Secondary outcome [8]
0
0
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Open-label Monotherapy Period
Query!
Assessment method [8]
0
0
An 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 be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Query!
Timepoint [8]
0
0
up 457 days
Query!
Secondary outcome [9]
0
0
Cmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Query!
Assessment method [9]
0
0
Cmax was defined as the maximum observed plasma concentration of retifanlimab.
Query!
Timepoint [9]
0
0
preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Query!
Secondary outcome [10]
0
0
Cmin of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Query!
Assessment method [10]
0
0
Cmin was defined as the minimum observed plasma concentration of retifanlimab.
Query!
Timepoint [10]
0
0
preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Query!
Secondary outcome [11]
0
0
Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Query!
Assessment method [11]
0
0
tmax was defined as the time to the maximum serum concentration of retifanlimab.
Query!
Timepoint [11]
0
0
preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Query!
Secondary outcome [12]
0
0
AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Query!
Assessment method [12]
0
0
AUC was defined as the area under the serum concentration versus time curve.
Query!
Timepoint [12]
0
0
preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/01/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
16/03/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
308
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Princess Alexandra Hospital Australia - Woolloongabba
Query!
Recruitment hospital [2]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [3]
0
0
Monash Medical Centre Clayton - Clayton
Query!
Recruitment postcode(s) [1]
0
0
04102 - Woolloongabba
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [3]
0
0
03168 - Clayton
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Louisiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Virginia
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Antwerpen
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Bruxelles
Query!
Country [11]
0
0
Denmark
Query!
State/province [11]
0
0
Herlev
Query!
Country [12]
0
0
Denmark
Query!
State/province [12]
0
0
Vejle
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Angers Cedex 2
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Besançon
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Bordeaux Cedex
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Lyon
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Marseille Cedex 5
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Montpellier
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Nice
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Paris Cedex 13
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Poitiers Cedex
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Rennes Cedex 09
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Rouen Cedex
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Saint Herblain
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Strasbourg
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Toulouse Cedex 9
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Villejuif Cedex
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Bonn
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Dresden
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hamburg
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Milano
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Milan
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Monserrato
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Napoli
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Padova
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Pisa
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Rimini
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
San Giovanni Rotondo
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Torrette
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Chuo-ku
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Fukuoka-shi
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Hidaka-shi
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Nagoya-shi
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Osaka-shi
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Sendai-shi
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Shinjuku-ku
Query!
Country [47]
0
0
Norway
Query!
State/province [47]
0
0
Bergen
Query!
Country [48]
0
0
Norway
Query!
State/province [48]
0
0
Oslo
Query!
Country [49]
0
0
Puerto Rico
Query!
State/province [49]
0
0
San Juan
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
A Coruña
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Barcelona
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Madrid
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Palma de Mallorca
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Sevilla
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Zaragoza
Query!
Country [56]
0
0
Sweden
Query!
State/province [56]
0
0
Goteborg
Query!
Country [57]
0
0
Sweden
Query!
State/province [57]
0
0
Lund
Query!
Country [58]
0
0
Sweden
Query!
State/province [58]
0
0
Stockholm
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
Brighton
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Cambridge
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Guildford
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Hull
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
Leeds
Query!
Country [64]
0
0
United Kingdom
Query!
State/province [64]
0
0
London
Query!
Country [65]
0
0
United Kingdom
Query!
State/province [65]
0
0
Manchester
Query!
Country [66]
0
0
United Kingdom
Query!
State/province [66]
0
0
Oxford
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Preston
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Sutton
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Truro
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Incyte Corporation
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04472429
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/29/NCT04472429/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/29/NCT04472429/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04472429
Download to PDF