Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Able to comprehend and willing to sign a written ICF for the study.
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Are 18 years of age or older (or as applicable per local country requirements).
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Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC.
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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.
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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.
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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.
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ECOG performance status 0 to 1.
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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.
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Willingness to avoid pregnancy or fathering children
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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 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
308 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Incyte Corporation Call Center (ex-US); Incyte Corporation Call Center (US)
Data sourced from clinicaltrials.gov
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