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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04969861




Registration number
NCT04969861
Ethics application status
Date submitted
9/07/2021
Date registered
21/07/2021
Date last updated
12/01/2023

Titles & IDs
Public title
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
Scientific 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)
Secondary ID [1] 0 0
20-214-36
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Head and Neck Cancer 0 0
Recurrent Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bempegaldesleukin
Treatment: Drugs - Pembrolizumab

Experimental: BEMPEG + Pembrolizumab - Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).

Active Comparator: Pembrolizumab Monotherapy - Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).


Treatment: Drugs: Bempegaldesleukin
Specified dose on specified days

Treatment: Drugs: Pembrolizumab
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Approximately 2 years
Primary outcome [2] 0 0
Objective Response Rate
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Progression-Free Survival
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Time to Deterioration
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Change in Global Health Status/Quality of Life
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events
Timepoint [4] 0 0
Screening baseline through end of study, approximately 2 years

Eligibility
Key inclusion criteria
- 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

0 - Fully active, able to carry on all pre-disease performance without restriction

1 - 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

2- 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

NOTE: Other protocol defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/04/2022
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Nebraska
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg Bundesland
Country [3] 0 0
Greece
State/province [3] 0 0
Attiki
Country [4] 0 0
Italy
State/province [4] 0 0
Lombardia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nektar Therapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
SFJ Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Merck Sharp & Dohme LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04969861
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Nektar Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04969861