A CD8 Positron Emission Tomography With Computed Tomography (PET/CT) Study Using ⁸⁹Zr Df-IAB22M2C in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab
NCT04955262 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2021-07-08
Summary
The main purpose of this study is to investigate the utility of the new investigational imaging agent ⁸⁹Zr Df-IAB22M2C (CD8 PET/CT tracer) to monitor CD8 T-cell expansion and trafficking within tumors and associated tissues in patients with metastatic melanoma undergoing treatment with bempegaldesleukin and nivolumab as a single agent and in combination.
Conditions
Interventions
- BIOLOGICAL
-
Bempegaldesleukin (NKTR-214)
Specified dose on specified days
- BIOLOGICAL
-
Specified dose on specified days
- DRUG
-
⁸⁹Zr-Df-IAB22M2C
Specified dose on specified days
Sponsors & Collaborators
-
ImaginAb, Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Study Director · Nektar Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-31
- Primary Completion
- 2021-06-30
- Completion
- 2022-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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