BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

Recurrent Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04969861
• Other study ID #: 20-214-36
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 9, 2022
• Est. completion date: April 22, 2022

Study information

• Verified date: November 2022
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Metastatic Head and Neck Cancer
• Recurrence
• Recurrent Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Bempegaldesleukin
Specified dose on specified days
• Pembrolizumab
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.

Locations

Country	Name	City	State
Austria	Universitätsklinikum Salzburg, Landeskrankenhaus,	Salzburg	Salzburg Bundesland
Greece	Attikon University General Hospital	Athens	Attiki
Italy	ASST Degli Spedali Civili di Brescia	Brescia	Lombardia
United States	Nebraska Methodist Hospital	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
Nektar Therapeutics	Merck Sharp & Dohme LLC, SFJ Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Approximately 2 years
Primary	Objective Response Rate	To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.	Approximately 2 years
Secondary	Progression-Free Survival	To compare progression-free survival (PFS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.	Approximately 2 years
Secondary	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.	Approximately 2 years
Secondary	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.	Approximately 2 years
Secondary	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	Screening baseline through end of study, approximately 2 years