NCT04969861

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

A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined With Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma With PD-L1 Expressing Tumors (PROPEL-36)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Head and Neck Cancer
• Recurrent Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Bempegaldesleukin	Specified dose on specified days
DRUG	Pembrolizumab	Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2021-07-21
• Last updated: 2023-01-12
• Results posted: 2022-12-15

Locations

4 sites across 4 countries: United States, Austria, Greece, Italy

Regulatory

• FDA-regulated drug study