THEORY

Does NCT07223541 meet its primary endpoint at primary completion?

Cemiplimab 350 MG Intravenous Solution · Clear Cell Renal Cell Carcinoma · Phase 2

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Trial

NCT
NCT07223541
Drug / intervention
Cemiplimab 350 MG Intravenous Solution
Indication
Clear Cell Renal Cell Carcinoma
Phase
2
Sponsor
University of Oklahoma
Primary completion
2029-08
Status
open

Theories (1)

75% likely to miss · raimo

target LAG-3 · moa checkpoint-inhibition · failure mode target-redundant

  1. premise investigator-led phase 2, n=72, oligo-metastatic ccRCC with SBRT; fianlimab (LAG-3) add-on on a cemiplimab (PD-1) backbone
  2. premise LAG-3 efficacy in renal cell carcinoma is unproven — no positive phase 3 precedent in this substrate
  3. inference a redundant second brake plus an underpowered superiority design (n=72) makes clearing a PFS superiority endpoint unlikely
  4. prediction no PFS superiority over cemiplimab; primary endpoint not met

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