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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 : June 9, 2023
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Anal Canal Drug: carboplatin Drug: paclitaxel Drug: retifanlimab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
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)
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : October 24, 2024
Estimated Study Completion Date : October 27, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Disease Control Rate(DCR) [ Time Frame: Up to 4.5 years ]
    Defined as the number of participants maintaining either an ORR or stable disease.

  5. 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.

  6. Cmax of retifanlimab when administered with chemotherapy [ Time Frame: Up to 4.5 years ]
    Maximum observed plasma or serum concentration.

  7. tmax of retifanlimab when administered with chemotherapy [ Time Frame: Up to 4.5 years ]
    Time to maximum concentration

  8. Cmin of retifanlimab when administered with chemotherapy [ Time Frame: Up to 4.5 years ]
    Minimum observed plasma or serum concentration over the dose interval

  9. 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


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472429


Contacts
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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

Locations
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Sponsors and Collaborators
Incyte Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04472429    
Other Study ID Numbers: INCMGA 0012-303
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: June 9, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
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
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Squamous cell carcinoma
carboplatin
paclitaxel
 PD-1 Inhibitor
Anal Cancer
SCAC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Paclitaxel
 Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action