Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

Completed · Phase 3 · Has a placebo group

Conditions studied: Squamous Cell Carcinoma of the Anal Canal

In brief

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.

Key facts

Study ID

NCT04472429

Run by

Incyte Corporation

People needed

308

Starts

2021-01-12

Expected to finish

2025-09-26

Last updated by the study team

2025-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify 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

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Texas Oncology — Austin, Texas, United States
• Baylor Scott and White Research Institute — Dallas, Texas, United States
• Renovatio Clinical Consultants Llc — The Woodlands, Texas, United States
• Texas Oncology-Wichita Falls Texoma Cancer Center — Wichita Falls, Texas, United States
• Virginia Cancer Specialists, Pc — Arlington, Virginia, United States
• Blue Ridge Cancer Care — Roanoke, Virginia, United States
• Princess Alexandra Hospital Australia — Woolloongabba, Queensland, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• Monash Medical Centre Clayton — Clayton, Victoria, Australia
• Zna Middelheim — Antwerp, Belgium
• Ulb Hospital Erasme — Brussels, Belgium
• Herlev Og Gentofte Hospital — Herlev, Denmark
• Vejle Hospital — Vejle, Denmark
• Institut de Cancerologie de L Ouest - Site Paul Papin — Angers, France
• Chu Besancon Hospital Jean Minjoz — Besançon, France
• Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France
• Centre Leon Berard — Lyon, France
• The University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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