drugset / Trial / NCT04969861

BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

NCT04969861 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (CPS ≥ 1).

Timeline

Start
2022-03-09
Primary completion
2022-04-22
Completion
2022-04-22

Outcome

Outcome not reported

Stopped: “Nektar Therapeutics made the decision to discontinue the bempegaldesleukin program based on three negative studies. SFJ Pharmaceuticals, Inc. and Nektar Therapeutics, in consultation with the study IDMC, have decided to discontinue PROPEL-36.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bempegaldesleukin Protein / enzyme biologic — —
Subject Pembrolizumab Monoclonal antibody — —

Indications