Squamous Cell Carcinoma of the Anal Canal
Conditions
Interventions
Parallel Assignment
Placebo Comparator:
Group A : carboplatin+paclitaxel+placebo
carboplatin will be administered intravenous on Day 1 of each 28 day cycle.
paclitaxel will be administered intravenou
Sponsors
Ono Shintaro
Eligibility
Sex/Gender
All
Inclusion 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 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/ micro L, 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
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 = Grade 2 by CTCAE v5. - Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) 2. Objective Response Rate (ORR) 3. Duration of Response (DOR) 4. Disease Control Rate(DCR) 5. Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period 6. Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Randomized Period 7.Number of Participants With Any TEAE During the Open-label Monotherapy Period 8. Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Open-label Monotherapy Period 9. Cmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel 10. Cmin of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel 11. Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel 12. AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel | — |
Countries
Australia, Belgium, Denmark, France, Germany, Italy, Japan, Norway, Puerto Rico, Spain, Sweden, United Kingdom, U.S.A
Contacts
Public ContactMedical Information Center
Incyte Biosciences Japan G.K.
Outcome results
None listed