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

• Status: Recruiting
• Trial end date: 2024-10-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Carboplatin; Paclitaxel

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 6 months prior to randomization.

• ECOG performance status 0 to 1.

• If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 300/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 (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.

• 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