Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
CompletedPhase 3Results postedLast updated 3 November 2025
What this trial tests
Phase 3 trial testing carboplatin in Squamous Cell Carcinoma of the Anal Canal in 308 participants. Completed in 26 September 2025.
18 and older, any sex, with Squamous Cell Carcinoma of the Anal Canal. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· up to 33.9 months
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
Group
Value
95% CI
Retifanlimab 500 mg Q4W + Chemotherapy
9.3
7.5 – 11.3
Placebo + Chemotherapy
7.4
7.1 – 7.7
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized PeriodSecondary· up to 535 days
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the la
Group
Value
95% CI
Retifanlimab 500 mg Q4W + Chemotherapy
154
Placebo + Chemotherapy
152
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Randomized PeriodSecondary· up to 535 days
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy.
Group
Value
95% CI
Retifanlimab 500 mg Q4W + Chemotherapy
17
Placebo + Chemotherapy
4
Cmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxelSecondary· preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Cmax was defined as the maximum observed plasma concentration of retifanlimab.
Group
Value
95% CI
Retifanlimab 500 mg Q4W + Chemotherapy
209
± 27.9
Cmin of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxelSecondary· preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Cmin was defined as the minimum observed plasma concentration of retifanlimab.
Group
Value
95% CI
Retifanlimab 500 mg Q4W + Chemotherapy
49.5
± 59.4
Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxelSecondary· preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
tmax was defined as the time to the maximum serum concentration of retifanlimab.
Group
Value
95% CI
Retifanlimab 500 mg Q4W + Chemotherapy
0.720
± 35.8
AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxelSecondary· preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
AUC was defined as the area under the serum concentration versus time curve.
Group
Value
95% CI
Retifanlimab 500 mg Q4W + Chemotherapy
2490
± 40.1
Adverse events — posted to ClinicalTrials.gov
Time frame: up to approximately 33 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07405190 — Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC
· Phase 2
· not yet recruiting
NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im
· Phase 2
· not yet recruiting
NCT07498907 — Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelia
· Phase 2
· not yet recruiting
NCT06694454 — Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immun
· Phase 1, PHASE2
· not yet recruiting
NCT07472517 — DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carbop
· Phase 3
· not yet recruiting
Other Incyte Corporation trials
Trials by the same sponsor.
NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di
· Phase 2
· recruiting
NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms
· Phase 1
· recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre
· Phase 3
· recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A
· Phase 1
· active not recruiting
NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 3 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04472429.