for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion



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.

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)


Squamous Cell Carcinoma of the Anal Canal, Squamous cell carcinoma, carboplatin, paclitaxel, PD-1 Inhibitor, Anal Cancer, SCAC, Carcinoma, retifanlimab, carboplatin+paclitaxel+retifanlimab


You can join if…

Open to people ages 18 years and up

  • 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.
      1. 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

You CAN'T join if...

  • 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


  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States


accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 3 research study
Study Type
Expecting 300 study participants
Last Updated