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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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ClinicalTrials.gov Identifier: NCT04472429
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE July 13, 2020
First Posted Date  ICMJE July 15, 2020
Last Update Posted Date July 29, 2021
Actual Study Start Date  ICMJE November 9, 2020
Estimated Primary Completion Date October 24, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
Progression Free Survival (PFS) [ Time Frame: up to 4.5 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • Overall Survival (OS) [ Time Frame: Up to 4.5 years ]
    Defined as the time from the date of randomization until death due to any cause.
  • Overall Response Rate (ORR) [ Time Frame: Up to 4.5 years ]
    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) [ Time Frame: Up to 4.5 years ]
    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) [ Time Frame: Up to 4.5 years ]
    Defined as the number of participants maintaining either an ORR or stable disease.
  • Number of treatment-emergent adverse events [ Time Frame: Up to 4.5 years ]
    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 [ Time Frame: Up to 4.5 years ]
    Maximum observed plasma or serum concentration.
  • tmax of retifanlimab when administered with chemotherapy [ Time Frame: Up to 4.5 years ]
    Time to maximum concentration
  • Cmin of retifanlimab when administered with chemotherapy [ Time Frame: Up to 4.5 years ]
    Minimum observed plasma or serum concentration over the dose interval
  • AUC0-t of retifanlimab when administered with chemotherapy [ Time Frame: Up to 4.5 years ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Anal Canal
Intervention  ICMJE
  • Drug: carboplatin
    carboplatin will be administered intravenous on Day 1 of each 28 day cycle
  • Drug: paclitaxel
    paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
  • Drug: retifanlimab
    retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
    Other Name: INCMGA00012
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
  • 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
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: retifanlimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 27, 2024
Estimated Primary Completion Date October 24, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 6 months prior to randomization.
    • ECOG performance status 0 to 1.
    • If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 300/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 (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.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   France,   Germany,   Italy,   Japan,   Norway,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04472429
Other Study ID Numbers  ICMJE INCMGA 0012-303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
URL: https://www.incyte.com/our-company/compliance-and-transparency
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Incyte Corporation
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP