Metastatic MelanomaPhase 1NCT04955262
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
A Phase 1 study testing Bempegaldesleukin (NKTR-214), Nivolumab and ⁸⁹Zr-Df-IAB22M2C in people with Metastatic Melanoma, run by Nektar Therapeutics at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Bempegaldesleukin (NKTR-214), Nivolumab and ⁸⁹Zr-Df-IAB22M2C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2019to Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Investigational Site - Duarte
Duarte, California, 91010
Investigational Site - Philadelphia
Philadelphia, Pennsylvania, 19104
Investigational Site - Portland
Portland, Oregon, 97213
About this study
Official title: A Phase 1b, Open Label, Multicenter Study of Positron Emission Tomography With Computed Tomography (PET/CT) Using ⁸⁹Zr Df-IAB22M2C (CD8 PET/CT Tracer) in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab
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.
Read the detailed 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.
⁸⁹Zr 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 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.
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 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.
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.
- Conditions
- Metastatic Melanoma
- Being tested
- Bempegaldesleukin (NKTR-214), Nivolumab, ⁸⁹Zr-Df-IAB22M2C
- 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
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempegaldesleukin (NKTR-214)Biological
Also called CD122-Biased Agonist, BMS-986321
Specified dose on specified days
NivolumabBiological
Also called Opdivo®, BMS-936658
Specified dose on specified days
⁸⁹Zr-Df-IAB22M2CDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Bempegaldesleukin (NKTR-214); Biological: Nivolumab; Drug: ⁸⁹Zr-Df-IAB22M2C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study startAug 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Did not initiate due to business reasons. IND is inactive.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ImaginAb, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955262
- Sponsor's protocol ID
- 18-214-12
- Status last verified
- Jun 2021
- First submitted
- 26 Jun 2019
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open Label, Multicenter Study of Positron Emission Tomography With Computed Tomography (PET/CT) Using ⁸⁹Zr Df-IAB22M2C (CD8 PET/CT Tracer) in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab
- ClinicalTrials.gov ID
- NCT04955262
- Acronym / sponsor ID
- 18-214-12
- Conditions
- Metastatic Melanoma
- Keywords
- CD122, Immuno-oncology, Immunotherapy, Natural Killer Cells, Interleukin-2, IL-2, Nivolumab, NKTR-214
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not initiate due to business reasons. IND is inactive.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- ImaginAb, Inc.
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
⁸⁹Zr 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 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.
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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells | Experimental | Biological: Bempegaldesleukin (NKTR-214), Biological: Nivolumab, Drug: ⁸⁹Zr-Df-IAB22M2CDuring 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. |
| Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells | Experimental | Biological: Bempegaldesleukin (NKTR-214), Biological: Nivolumab, Drug: ⁸⁹Zr-Df-IAB22M2CDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempegaldesleukin (NKTR-214)Also: CD122-Biased Agonist, BMS-986321Specified dose on specified days | Biological | Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells, Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells |
| NivolumabAlso: Opdivo®, BMS-936658Specified dose on specified days | Biological | Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells, Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells |
| ⁸⁹Zr-Df-IAB22M2CSpecified dose on specified days | Drug | Part 1 Initial Cohort to Evaluate the Biodistribution of CD8 Cells, Part 2 Expansion Cohort to Evaluate the Biodistribution of CD8 Cells |
Primary outcome
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.
Time frame: Approximately 18 months
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.
Correlate ⁸⁹Zr Df-IAB22M2C lesion uptake with lesion size and ORR using PET/CT scans
Time frame: Approximately 18 months
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Nektar Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bempegaldesleukin (NKTR-214), Nivolumab and ⁸⁹Zr-Df-IAB22M2C in people with Metastatic Melanoma, run by Nektar Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Approximately 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.