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)
Verified date | November 2022 |
Source | Nektar Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Nektar Therapeutics | Merck Sharp & Dohme LLC, SFJ Pharmaceuticals, Inc. |
United States, Austria, Greece, Italy,
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 |
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