Melanoma Clinical Trial
A CD8 Positron Emission Tomography With Computed Tomography (PET/CT) Study Using â¸â¹Zr Df-IAB22M2C in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab
Summary
The main purpose of this study is to investigate the utility of the new investigational imaging agent â¸â¹Zr 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.
Full Description
NKTR-214 is a cytokine (Investigational Agent), a protein which is found to expand certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to promote their anti-tumor effects. Nivolumab is a full human monoclonal antibody that binds to a molecule called PD-1 (programmed cell death protein 1) on immune cells and promotes anti-tumor effects.
â¸â¹Zr Df-IAB22M2C is an experimental injected molecule containing a radioactive atom; this molecule attaches to CD8+ T cells and allows those T cells to be seen on PET/CT scans.
Part 1: A total of 4 eligible patients will be enrolled into part 1. During Cycle 1, patients will receive single agent NKTR-214, 3 injections â¸â¹Zr 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.
Part 2: A total of 20 eligible patient will be enrolled into part 2. During Cycle 1, patients will receive single agent NKTR-214 or nivolumab, 2 injections of â¸â¹Zr 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 â¸â¹Zr Df-IAB22M2C and 1 PET/CT scan.
All patients enrolled in the study will be closely monitored to determine if there is response to the treatment as well as for any side effects that may occur. The efficacy of the combination will be assessed using objective response rate (ORR). Exploratory immunological biomarkers in plasma and tumor samples will evaluate immune activation.
Eligibility 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
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There are 3 Locations for this study
Duarte California, 91010, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19104, United States
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