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

Part of paid clinical trials in Duarte, California.

Sponsor
Nektar Therapeutics
Study ID
NCT04955262
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bempegaldesleukin (NKTR-214) — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • ⁸⁹Zr-Df-IAB22M2C — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Aug 31, 2019
Status verified
Jun 2021
Primary completion
Jun 30, 2021
Completion
Jan 31, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells
    During Cycle 1, patients will receive single-agent NKTR-214, 3 injections of 89Zr-Df-IAB22M2C, and 6 PET/CT scans. Starting with Cycle 2, patients will receive NKTR-214 in combination with nivolumab q3w for the remainder of the study. Once the PET/CT imaging data from Part 1 have been reviewed, Part 2 will open for enrollment.
  • Experimental: Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells
    During Cycle 1, patients will receive single-agent NKTR-214 or nivolumab, 2 injections of 89Zr-Df-IAB22M2C, and 3 PET/CT scans. In Cycle 2 and beyond, patients will receive NKTR-214 in combination with nivolumab q3w for the remainder of the study. During Cycle 2, patients will receive 1 injection of 89Zr-Df-IAB22M2C and 1 PET/CT scan.

Primary Outcome Measure

Lesion uptake of 89Zr-Df-IAB22M2C (CD8 PET/CT tracer) before and after monotherapy treatment with mechanistically different immunotherapies, bempegaldesleukin (NKTR-214) and nivolumab as well as after combination treatment with NKTR-214 and nivolumab. [ Time Frame: Approximately 18 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Investigational Site - DuarteDuarteCalifornia91010-
Investigational Site - PortlandPortlandOregon97213-
Investigational Site - PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Duarte, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Investigational Site - Duarte· Duarte, CAInvestigational Site - Portland· Portland, ORInvestigational Site - Philadelphia· Philadelphia, PA

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