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Trial record 1 of 1 for:    PROPEL-36
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BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04969861
Recruitment Status : Terminated (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.)
First Posted : July 21, 2021
Last Update Posted : June 1, 2022
Sponsor:
Collaborators:
SFJ Pharmaceuticals, Inc.
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Nektar Therapeutics

Tracking Information
First Submitted Date  ICMJE July 9, 2021
First Posted Date  ICMJE July 21, 2021
Last Update Posted Date June 1, 2022
Actual Study Start Date  ICMJE March 9, 2022
Actual Primary Completion Date April 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • Overall Survival [ Time Frame: Approximately 2 years ]
    To compare the overall survival (OS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
  • Objective Response Rate [ Time Frame: Approximately 2 years ]
    To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • Progression-Free Survival [ Time Frame: Approximately 2 years ]
    To compare progression-free survival (PFS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
  • Time to Deterioration [ Time Frame: Approximately 2 years ]
    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.
  • Change in Global Health Status/Quality of Life [ Time Frame: Approximately 2 years ]
    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.
  • Percentage of Patients with Treatment-Emergent Adverse Events and Serious Adverse Events [ Time Frame: Screening baseline through end of study, approximately 2 years ]
    Compare the overall safety and tolerability based on assessments of treatment-emergent adverse events and serious adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
Official Title  ICMJE A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin (NKTR-214) Combined With Pembrolizumab vs. Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent HNSCC With PD-L1 Expressing Tumors
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Head and Neck Cancer
  • Recurrent Head and Neck Cancer
Intervention  ICMJE
  • Drug: Bempegaldesleukin
    Specified dose on specified days
  • Drug: Pembrolizumab
    Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
Study Arms  ICMJE
  • Experimental: BEMPEG + Pembrolizumab
    Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
    Interventions:
    • Drug: Bempegaldesleukin
    • Drug: Pembrolizumab
  • Active Comparator: Pembrolizumab Monotherapy
    Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
    Intervention: Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 3, 2022)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2021)
500
Actual Study Completion Date  ICMJE April 22, 2022
Actual Primary Completion Date April 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   France,   Greece,   Israel,   Italy,   Netherlands,   Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04969861
Other Study ID Numbers  ICMJE 20-214-36
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Nektar Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nektar Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • SFJ Pharmaceuticals, Inc.
  • Merck Sharp & Dohme LLC
Investigators  ICMJE
Study Director: Study Director Nektar Therapeutics
PRS Account Nektar Therapeutics
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP