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Withdrawn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

First listed
Jul 8, 2021
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

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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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