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)

  • STATUS
    Recruiting
  • End date
    Oct 27, 2024
  • participants needed
    300
  • sponsor
    Incyte Corporation
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Updated on 23 October 2022
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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.

Details
Condition Squamous Cell Carcinoma of the Anal Canal
Treatment carboplatin, Paclitaxel, Retifanlimab
Clinical Study IdentifierNCT04472429
SponsorIncyte Corporation
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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