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20-214-36/Nektar Propel-36

Trial Overview

Official Title

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)

Study Purpose

To compare the overall survival and the objective response rate of bempegaldesleukin plus pembrolizumab vs. pembrolizumab monotherapy.

Diagnosis

Patients with recurrent or metastatic head and neck squamous-cell carcinoma

Eligibility

Metastatic/recurrent Head oropharynx

Patients with oral cavity, hypopharynx, and larynx SCC.

PD-L1 Positive.

No prior therapy in metastatic/recurrent setting

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

Group 1: Bempegaldesleukin plus pembrolizumab every three weeks for up to 35 cycles

Group 2: Pembrolizumab monotherapy every 3 weeks for up to 35 cycles

For more information, visit Clinicaltrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
Propel-36
Related Specialties