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

NCT04969861 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-214-36
• Study Type: interventional
• Target: 1
• Locations: 4 countries
• Sites: 4

Brief 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

Keywords

Head and Neck Cancer; Head and Neck Squamous-Cell Carcinoma; HNSCC; BEMPEG; Bempegaldesleukin; NKTR-214; Keytruda; Pembrolizumab; PROPEL-36

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Approximately 2 years

• Objective Response Rate

  To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.

  Approximately 2 years

Secondary Outcomes (4)

• Progression-Free Survival

  Approximately 2 years

• Time to Deterioration

  Approximately 2 years

• Change in Global Health Status/Quality of Life

  Approximately 2 years

• Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events

  Screening baseline through end of study, approximately 2 years

Study Arms (2)

BEMPEG + Pembrolizumab

EXPERIMENTAL

Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).

Drug: Bempegaldesleukin; Drug: Pembrolizumab

Pembrolizumab Monotherapy

ACTIVE COMPARATOR

Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).

Drug: Pembrolizumab

Interventions

Bempegaldesleukin DRUG

Specified dose on specified days

BEMPEG + Pembrolizumab

Pembrolizumab DRUG

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

BEMPEG + Pembrolizumab; Pembrolizumab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written, informed consent to participate in the study and follow the study procedures.
• Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
• Have histologically or cytologically-confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
• No prior systemic therapy for recurrent or metastatic disease.
• The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
• Patients may not have a primary tumor site of nasopharynx (any histology) and/or unknown primary.
• Have measurable disease based on RECIST 1.1 as determined by the local site Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Measure Description: GRADE - ECOG PERFORMANCE STATUS
• Fully active, able to carry on all pre-disease performance without restriction
• Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
• Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• The tumor must have positive PD-L1 expression (i.e., CPS ≥1)

You may not qualify if:

• Has disease that is suitable for local therapy administered with curative intent.
• Has progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
• Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to initiation of study drug
• Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) as determined by the Investigator.
• Has a known additional malignancy that is progressing or has required active treatment within 5 years prior to the first dose of study drug
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
• Use of an investigational agent or an investigational device within 28 days before the first dose of study drug.
• Prior treatment with an anti PD-1, anti PD-L1, anti-PD-L2, or anti CTLA-4 antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Sponsors & Collaborators

• Nektar Therapeutics: lead
• SFJ Pharmaceuticals, Inc.: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Universitätsklinikum Salzburg, Landeskrankenhaus,

Salzburg, Salzburg Bundesland, 5020, Austria

Location

Attikon University General Hospital

Athens, Attica, Greece

Location

ASST Degli Spedali Civili di Brescia

Brescia, Lombardy, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

bempegaldesleukin; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Study Director
• Organization: Nektar Therapeutics

StudyInquiry@nektar.com

415-482-5300

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 21, 2021
• Study Start: March 9, 2022
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: January 12, 2023
• Results First Posted: December 15, 2022

Record last verified: 2022-11

Locations

GR (1); AU (1); US (1); IT (1)