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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)
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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)
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Secondary ID [1]
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20-214-36
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Head and Neck Cancer
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Recurrent Head and Neck Cancer
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Condition category
Condition code
Cancer
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Head and neck
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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Timepoint [1]
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Approximately 2 years
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Primary outcome [2]
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Objective Response Rate
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Assessment method [2]
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To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
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Timepoint [2]
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Approximately 2 years
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Secondary outcome [1]
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Progression-Free Survival
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Assessment method [1]
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To compare progression-free survival (PFS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
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Timepoint [1]
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Approximately 2 years
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Secondary outcome [2]
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Time to Deterioration
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Assessment method [2]
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The time from baseline to a = 10-point decrease with confirmation by the subsequent visit of a = 10-point deterioration from baseline in:
• Global health status/quality of life assessment based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30).
The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients. All scale scores are linearly converted to range from 0 to 100. A higher total score indicates a better level of functioning.
• Pain and Swallowing based on respective multi-item scales of EORTC QLQ head and neck cancer specific module (EORTC QLQ-H&N35).
EORTC QLQ-H&N35 consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. All scale scores are linearly converted to range from 0 to 100. A higher total score indicates increased severity of symptoms.
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Timepoint [2]
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Approximately 2 years
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Secondary outcome [3]
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Change in Global Health Status/Quality of Life
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Assessment method [3]
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To compare mean change from baseline in global health status/quality of life scale of EORTC QLQ-C30. The EORTC QLQ-C30 is composed of multi-item scales and single item measures. These include 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), a global health status/HRQoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All scale scores are linearly converted to range from 0 to 100. A higher total score indicates a better level of functioning.
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Timepoint [3]
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Approximately 2 years
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Secondary outcome [4]
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Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events
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Assessment method [4]
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Compare the overall safety and tolerability based on assessments of treatment-emergent adverse events and serious adverse events
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Timepoint [4]
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Screening baseline through end of study, approximately 2 years
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/04/2022
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Sample size
Target
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Accrual to date
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Final
1
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Nebraska
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Country [2]
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Austria
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State/province [2]
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Salzburg Bundesland
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Country [3]
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Greece
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State/province [3]
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Attiki
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Country [4]
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Italy
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State/province [4]
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Lombardia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Nektar Therapeutics
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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SFJ Pharmaceuticals, Inc.
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Merck Sharp & Dohme LLC
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Address [2]
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04969861
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Trial related presentations / publications
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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
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Contacts
Principal investigator
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Study Director
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Address
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Nektar Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04969861
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