Clinical Trial · NCT04955262

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

Overview

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.

Sponsor

United Therapeutics

Phase

Phase 1

Contacts

Study Director (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT04955262

Drug / Compound

Df-IAB22M2C

Isotope(s):

Target(s):

CD8 Cells

Ligand Class: Small Proteins and Antibody Fragments

Chelator: DFO

Eligibility

Inclusion

Patients must have histologically confirmed metastatic melanoma with measurable, stage IV disease per American Joint Committee on Cancer (AJCC) staging system
Measurable disease per RECIST 1.1 criteria
* Provide written, informed consent to participate in the study and follow the study procedures
In patients with a single RECIST measurable lesion, the lesion must be a non-cutaneous lesion.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion

Patients must not have received prior IL-2 therapy
* Patients who have an active, known or suspected autoimmune disease
Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte associated protein 4 (anti CTLA-4) antibody, agents that target IL-2, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways
Need for \>2 antihypertensive medications for hypertension managementOther protocol-defined inclusion/exclusion criteria apply