Status:
COMPLETED
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Lead Sponsor:
Incyte Corporation
Conditions:
Squamous Cell Carcinoma of the Anal Canal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
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
Exclusion
- 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
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2025
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT04472429
Start Date
January 12 2021
End Date
September 26 2025
Last Update
November 3 2025
Active Locations (84)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
Sansum Clinic
Santa Barbara, California, United States, 93105