Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04969861
Other study ID # 20-214-36
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05738187 - Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study N/A
Recruiting NCT02567383 - Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer Phase 2
Recruiting NCT05980000 - Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma Phase 2
Active, not recruiting NCT03691714 - Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 2
Terminated NCT02842125 - Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Active, not recruiting NCT04260126 - Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC Phase 2
Completed NCT02358031 - A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) Phase 3
Completed NCT02422979 - Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer Phase 1/Phase 2
Completed NCT04902027 - A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers Phase 1
Recruiting NCT04534205 - A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 Phase 2
Active, not recruiting NCT02289209 - Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck Phase 2
Recruiting NCT06239220 - PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC Phase 2
Recruiting NCT04673929 - Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
Recruiting NCT03754933 - Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer Phase 1/Phase 2
Terminated NCT03937141 - Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer Phase 2
Terminated NCT00088907 - Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer Phase 3
Completed NCT01620242 - A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes Phase 2
Terminated NCT01606566 - A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer. Phase 2
Completed NCT01255800 - Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer Phase 1