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
Results First Posted : December 15, 2022
Last Update Posted : January 12, 2023
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Head and Neck Cancer Recurrent Head and Neck Cancer||Drug: Bempegaldesleukin Drug: Pembrolizumab||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||March 9, 2022|
|Actual Primary Completion Date :||April 22, 2022|
|Actual Study Completion Date :||April 22, 2022|
Experimental: BEMPEG + Pembrolizumab
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
Specified dose on specified days
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
Active Comparator: Pembrolizumab Monotherapy
Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969861
|United States, Nebraska|
|Nebraska Methodist Hospital|
|Omaha, Nebraska, United States, 68114|
|Universitätsklinikum Salzburg, Landeskrankenhaus,|
|Salzburg, Salzburg Bundesland, Austria, 5020|
|Attikon University General Hospital|
|Athens, Attiki, Greece|
|ASST Degli Spedali Civili di Brescia|
|Brescia, Lombardia, Italy|
|Study Director:||Study Director||Nektar Therapeutics|
Documents provided by Nektar Therapeutics:
|Responsible Party:||Nektar Therapeutics|
|Other Study ID Numbers:||
|First Posted:||July 21, 2021 Key Record Dates|
|Results First Posted:||December 15, 2022|
|Last Update Posted:||January 12, 2023|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Head and Neck Cancer
Head and Neck Squamous-Cell Carcinoma
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms by Site
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological