Clinical trial NCT04969861: BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Metastatic Head and Neck Cancer
Recurrent Head and Neck Cancer
Keywords: Head and Neck Cancer
Head and Neck Squamous-Cell Carcinoma
HNSCC
BEMPEG
Bempegaldesleukin
NKTR-214
Keytruda
Pembrolizumab
PROPEL-36
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: SFJ Pharmaceuticals, Inc.
name: Merck Sharp & Dohme LLC
First posted: 2021-07-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: Approximately 2 years
measure: Objective Response Rate
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: Approximately 2 years
measure: Time to Deterioration
timeFrame: Approximately 2 years
measure: Change in Global Health Status/Quality of Life
timeFrame: Approximately 2 years
measure: Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events
timeFrame: Screening baseline through end of study, approximately 2 years
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Salzburg
country: Austria
facility: Universitätsklinikum Salzburg, Landeskrankenhaus,
state: Salzburg Bundesland
city: Athens
country: Greece
facility: Attikon University General Hospital
state: Attiki
city: Brescia
country: Italy
facility: ASST Degli Spedali Civili di Brescia
state: Lombardia
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: