XCancer

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

Description:

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)

Government Study Link:

NCT04955262 - Click here to see study on

ClinicalTrials.gov

Df-IAB22M2C

Isotope(s):
Target(s):
  • CD8 Cells
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DFO
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