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

• Status: Withdrawn
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nektar Therapeutics
• Collaborator: ImaginAb, Inc.
• Treatments: Nivolumab

Criteria

Key Inclusion Criteria:

• Provide written, informed consent to participate in the study and follow the study procedures

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

• Measurable disease per RECIST 1.1 criteria

• Patients must have histologically confirmed metastatic melanoma with measurable, stage IV disease per American Joint Committee on Cancer (AJCC) staging system

• In patients with a single RECIST measurable lesion, the lesion must be a non-cutaneous lesion.

• Fresh biopsy

• Treatment-naive patients (i.e., no prior systemic anticancer therapy for unresectable or metastatic melanoma).

Key Exclusion Criteria:

• Patients who have an active, known or suspected autoimmune disease

• Patients must not have received prior IL-2 therapy

• 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 management

Other protocol-defined inclusion/exclusion criteria apply