Metastatic Head and Neck CancerPhase 2/3NCT04969861
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
A Phase 2/3 study testing Bempegaldesleukin and Pembrolizumab in people with Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, run by Nektar Therapeutics at 4 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
- What is being tested?
- Bempegaldesleukin and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 9 Mar 2022to 22 Apr 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Austria1 site
Universitätsklinikum Salzburg, Landeskrankenhaus,
Salzburg, Salzburg Bundesland, 5020
About this study
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)
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).
- Being tested
- Bempegaldesleukin, Pembrolizumab
- Keywords
- Head and Neck Cancer, Head and Neck Squamous-Cell Carcinoma, HNSCC, BEMPEG, Bempegaldesleukin, NKTR-214, Keytruda, Pembrolizumab, PROPEL-36
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BempegaldesleukinDrug
Specified dose on specified days
PembrolizumabDrug
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
| Study group | Role | What they receive |
|---|---|---|
| BEMPEG + Pembrolizumab | Experimental | Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years). Receives: Drug: Bempegaldesleukin; Drug: Pembrolizumab |
| Pembrolizumab Monotherapy | Active comparator | Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years). Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Approximately 2 years
Objective Response Rate
To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
Measured: Approximately 2 years
Secondary outcomes (4)
Progression-Free Survival
To compare progression-free survival (PFS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
Measured: Approximately 2 years
Time to Deterioration
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.
Measured: Approximately 2 years
Change in Global Health Status/Quality of Life
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.
Measured: Approximately 2 years
Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events
Compare the overall safety and tolerability based on assessments of treatment-emergent adverse events and serious adverse events
Measured: Screening baseline through end of study, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start9 Mar 2022
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Why it stopped: Nektar Therapeutics made the decision to discontinue the bempegaldesleukin program based on three negative studies. SFJ Pharmaceuticals, Inc. and Nektar Therapeutics, in consultation with the study IDMC, have decided to discontinue PROPEL-36.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SFJ Pharmaceuticals, Inc., Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969861
- Sponsor's protocol ID
- 20-214-36
- Status last verified
- Nov 2022
- First submitted
- 9 Jul 2021
- Last updated
- 12 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04969861
- Acronym / sponsor ID
- 20-214-36
- Keywords
- Head and Neck Cancer, Head and Neck Squamous-Cell Carcinoma, HNSCC, BEMPEG, Bempegaldesleukin, NKTR-214, Keytruda, Pembrolizumab
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Nektar Therapeutics made the decision to discontinue the bempegaldesleukin program based on three negative studies. SFJ Pharmaceuticals, Inc. and Nektar Therapeutics, in consultation with the study IDMC, have decided to discontinue PROPEL-36.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- SFJ Pharmaceuticals, Inc., Merck Sharp & Dohme LLC
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 15 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEMPEG + Pembrolizumab | Experimental | Drug: Bempegaldesleukin, Drug: PembrolizumabBempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years). |
| Pembrolizumab Monotherapy | Active comparator | Drug: PembrolizumabPembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BempegaldesleukinSpecified dose on specified days | Drug | BEMPEG + Pembrolizumab |
| PembrolizumabPembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual. | Drug | BEMPEG + Pembrolizumab, Pembrolizumab Monotherapy |
Primary outcome
Overall Survival
Time frame: Approximately 2 years
Objective Response Rate
Time frame: Approximately 2 years
To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
4 secondary outcomes
Progression-Free Survival
Time frame: Approximately 2 years
Time to Deterioration
Time frame: Approximately 2 years
Change in Global Health Status/Quality of Life
Time frame: Approximately 2 years
Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: Screening baseline through end of study, approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Nektar Therapeutics
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bempegaldesleukin and Pembrolizumab in people with Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, run by Nektar Therapeutics at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Austria, Greece, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.