Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma
NCT04936841 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2024-04-04
Summary
This trial will evaluate safety and efficacy of the combination of anti-PD1, NKTR-214, and palliative radiation therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Twenty-four participants will be enrolled to evaluate the efficacy of this combination.
Conditions
Interventions
- DRUG
-
NKTR-214
Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)
- DRUG
-
anti-PD-1 therapy
immunotherapy drug, monoclonal antibody
- RADIATION
-
Palliative Radiation
radiation to relieve symptoms
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Zachary Morris, MD, PhD · University of Wisconsin, Madison
-
Paul Harari, MD · University of Wisconsin, Madison
-
Adam Burr, MD, PhD · University of Wisconsin, Madison
-
Justine Bruce, MD · University of Wisconsin, Madison
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-05
- Primary Completion
- 2022-10-04
- Completion
- 2022-10-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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