POD1UM-303 / InterAACT 2: This phase III trial will add a type of immunotherapy to chemotherapy treatment in patients with recurrent or metastatic squamous cell carcinoma of the anal canal, to see if it is more or less effective than using chemotherapy on its' ownA 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)

Inclusion

• 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