Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
← catalyst calendarNCT06947928 · readout in 224 d
Sponsored by TuHURA Biosciences, Inc. (industry) · HURA — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
118estimated
Sites
18
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-11 | actual | When the study began enrolling |
| Primary completion | 2027-03-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-12-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Or Metastatic Merkel Cell Carcinoma
Interventions
- Drug: IFx-Hu2.0 — also filed as pAc/emm55
- Drug: Placebo
- Drug: Pembrolizumab — also filed as KEYTRUDA
Primary outcome
what the primary-completion date above is the date OFObjective response rate (ORR)
measured 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment
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