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

NCT04955262 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 18-214-12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Metastatic Melanoma

Keywords

CD122; Immuno-oncology; Immunotherapy; Natural Killer Cells; Interleukin-2; IL-2; Nivolumab; NKTR-214; Bempegaldesleukin; Opdivo®; PD-L1; PET/CT; CD8; T-cell; Imaging; Melanoma; TIL

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Approximately 18 months

• Correlate ⁸⁹Zr Df-IAB22M2C lesion uptake with lesion size and ORR using PET/CT scans

  Correlation between amount of ⁸⁹Zr Df-IAB22M2C lesion uptake (before and after monotherapy treatment and after combination treatment) with the change in lesion size and the objective response rate (ORR)

  Approximately 18 months

Study Arms (2)

Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells

EXPERIMENTAL

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.

Biological: Bempegaldesleukin (NKTR-214); Biological: Nivolumab; Drug: ⁸⁹Zr-Df-IAB22M2C

Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells

EXPERIMENTAL

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.

Biological: Bempegaldesleukin (NKTR-214); Biological: Nivolumab; Drug: ⁸⁹Zr-Df-IAB22M2C

Interventions

Bempegaldesleukin (NKTR-214) BIOLOGICAL

Specified dose on specified days

Also known as: CD122-Biased Agonist, BMS-986321

Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells; Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo®, BMS-936658

Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells; Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells

⁸⁹Zr-Df-IAB22M2C DRUG

Specified dose on specified days

Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells; Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead
• ImaginAb, Inc.: collaborator

Study Sites (3)

Investigational Site - Duarte

Duarte, California, 91010, United States

Location

Investigational Site - Portland

Portland, Oregon, 97213, United States

Location

Investigational Site - Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

bempegaldesleukin; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 8, 2021
• Study Start: August 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)