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

NCT04969861 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-01-12

Study results available
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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

DRUG

Bempegaldesleukin

Specified dose on specified days

DRUG

Pembrolizumab

Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Nektar Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2022-04-22
Completion
2022-04-22
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Greece
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04969861 on ClinicalTrials.gov