MelanomaPhase 1NCT07838974
Adding Anakinra and Tocilizumab to Nivolumab and Ipilimumab for the Treatment of Melanoma Patients 50 Years of Age or Older
A Phase 1 study testing Anakinra, Biospecimen Collection and Computed Tomography in people with Melanoma, run by University of Southern California at 1 site in United States.
Trial summary
This phase I trial studies the side effects of adding anakinra and tocilizumab to standard treatment with nivolumab and ipilimumab and to see how well it works in treating melanoma patients who are 50 years of age or older. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Anakinra, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years old
- Patients with melanoma, who are going to be treated with ipilimumab 1mg/Kg and nivolumab 3mg/Kg as a standard of care (SOC)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Platelets ≥ 50 000/µL
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1500/μL
Show all 12Show fewer
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 3.0 X institutional ULN (up to 5 X institutional ULN if patient has liver metastases)
- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 X institutional ULN (up to 5 X institutional ULN if patient has liver metastases)
- Creatinine < 2.0 ULN
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Willingness to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol
Who cannot join
- Patients must not be receiving other concomitant biologic therapy, targeted therapy, chemotherapy, other anti-cancer therapy or any other investigational agents while on this protocol
- Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first cycle
- Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements
- Positive pregnancy test, active pregnancy or nursing / breast-feeding, due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
- History of solid organ or bone marrow transplantation
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Fumito Ito, 323-442-8140, Fumito.ito@med.usc.edu
Fumito Ito
About this study
Official title: Targeting Inflammaging-Associated Cytokine Signaling to Improve Efficacy and Reduce Immune-Related Toxicities of Anti-PD-1/CTLA-4 Therapy
This phase I trial studies the side effects of adding anakinra and tocilizumab to standard treatment with nivolumab and ipilimumab and to see how well it works in treating melanoma patients who are 50 years of age or older. Anakinra and tocilizumab are used to decrease the body's immune response and lower side effects. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Researchers think that anakinra and tocilizumab may reduce the side effects experienced from standard treatment with nivolumab and ipilimumab while also preserving their anti-cancer effects. Adding anakinra and tocilizumab to standard treatment with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating melanoma patients who are 50 years of age or older.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the tolerated dose of the combination of anakinra and tocilizumab that can be used in conjunction with nivolumab and ipilimumab for further evaluation in patients 50 years of age or older at the start of treatment.
SECONDARY OBJECTIVES:
- To evaluate the safety of the combination based on Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0.
II. To evaluate the incidence of discontinuation of immune checkpoint inhibitor (ICI) therapy due to grade 3 or higher immune-related adverse events (irAEs).
III. To evaluate objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1) by investigator assessment (objective response rate [ORR] will be reported separately for patients treated neoadjuvant therapy versus [vs.] others).
IV. To evaluate overall survival (OS). V. To assess progression-free survival (PFS).
EXPLORATORY OBJECTIVES:
- To evaluate change in serum cytokine/chemokine profile. II. To profile peripheral blood (PB) immune subsets.
OUTLINE: This is a dose de-escalation study of anakinra in combination with tocilizumab, nivolumab, and ipilimumab.
Patients receive anakinra subcutaneously (SC) once daily (QD) on days 1-21 of each cycle, once every other day of each cycle, or once every 3 days of each cycle. Patients also receive tocilizumab intravenously (IV), nivolumab IV, and ipilimumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) or positron emission tomography (PET)/CT during screening and as clinically indicated as well as blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 1 week and then every 6 months for up to 2 years.
- Conditions
- Melanoma
- Being tested
- Anakinra, Biospecimen Collection, Computed Tomography, Electronic Health Record Review, Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraBiological
Also called Kinaret, Kineret, rIL-1ra, rIL1RN
Given SC
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT or PET/CT
Electronic Health Record ReviewOther
Ancillary studies
IpilimumabBiological
Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
TocilizumabBiological
Also called Actemra, Avtozma, IL-6 receptor monoclonal antibodies: tocilizumab, Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) | Experimental | Patients receive anakinra SC QD on days 1-21 of each cycle, once every other day of each cycle, or once every 3 days of each cycle. Patients also receive tocilizumab IV, nivolumab IV, and ipilimumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT or PET/CT during screening and as clinically indicated as well as blood sample collection throughout the study. Receives: Biological: Anakinra; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography; Biological: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerated dose of the combination of anakinra and tocilizumab that can be used in conjunction with nivolumab and ipilimumab in patients 50 years or older
Measured: Up to 12 weeks
Secondary outcomes (4)
Incidence of discontinuation of immune checkpoint inhibitor therapy due to grade 3 or higher immune-related adverse events
This analysis will be conducted for each dose level examined separately. The estimand for this objective will be the number of patients with the objective's outcome measure coded as yes divided by the number of patients evaluable for this objective. Exact confidence interval of this proportion will also be calculated.
Measured: Up to 12 weeks
Objective response rate
Will evaluate objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) by investigator assessment. This analysis will be conducted for each dose level examined separately. The estimand for this objective will be the number of patients demonstrating each RECIST category divided by the number of patients evaluable for this objective. The best response rate will be estimated by the number of patients who demonstrate partial response or complete response divided by the number of patients evaluable for this objective.
Measured: Up to 2 years
Overall survival
The probability of remaining alive as a function of time since enrollment will be calculated by the method of Kaplan and Meier (Kaplan EL and Meier P. Nonparametric estimation from incomplete observations. J Amer Statist Assoc, 457-481, 1958). The one year and two-year estimates will be reported for each dose group separately and for the aggregated evaluable population. There is no plan to conduct statistical comparisons between the dose groups.
Measured: From first dose of treatment to death due to any cause, assessed up to 2 years
Progression free survival (PFS)
The probability of remaining PFS-event free as a function of time since enrollment will be calculated by the method of Kaplan and Meier (Kaplan EL and Meier P. Nonparametric estimation from incomplete observations. J Amer Statist Assoc, 457-481, 1958). The one year and two-year estimates will be reported for each dose group separately and for the aggregated evaluable population. There is no plan to conduct statistical comparisons between the dose groups.
Measured: From start of treatment to time of progression or death whichever comes first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Fumito Ito, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838974
- Sponsor's protocol ID
- 10M-26-3
- Other IDs
- NCI-2026-06741, HS-26-00490, 10M-26-3, P30CA014089
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Inflammaging-Associated Cytokine Signaling to Improve Efficacy and Reduce Immune-Related Toxicities of Anti-PD-1/CTLA-4 Therapy
- ClinicalTrials.gov ID
- NCT07838974
- Acronym / sponsor ID
- 10M-26-3
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 24 Sep 2026 (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.
This phase I trial studies the side effects of adding anakinra and tocilizumab to standard treatment with nivolumab and ipilimumab and to see how well it works in treating melanoma patients who are 50 years of age or older. Anakinra and tocilizumab are used to decrease the body's immune response and lower side effects. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Researchers think that anakinra and tocilizumab may reduce the side effects experienced from standard treatment with nivolumab and ipilimumab while also preserving their anti-cancer effects. Adding anakinra and tocilizumab to standard treatment with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating melanoma patients who are 50 years of age or older.
Detailed description
PRIMARY OBJECTIVES:
- To establish the tolerated dose of the combination of anakinra and tocilizumab that can be used in conjunction with nivolumab and ipilimumab for further evaluation in patients 50 years of age or older at the start of treatment.
SECONDARY OBJECTIVES:
- To evaluate the safety of the combination based on Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0.
II. To evaluate the incidence of discontinuation of immune checkpoint inhibitor (ICI) therapy due to grade 3 or higher immune-related adverse events (irAEs).
III. To evaluate objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1) by investigator assessment (objective response rate [ORR] will be reported separately for patients treated neoadjuvant therapy versus [vs.] others).
IV. To evaluate overall survival (OS). V. To assess progression-free survival (PFS).
EXPLORATORY OBJECTIVES:
- To evaluate change in serum cytokine/chemokine profile. II. To profile peripheral blood (PB) immune subsets.
OUTLINE: This is a dose de-escalation study of anakinra in combination with tocilizumab, nivolumab, and ipilimumab.
Patients receive anakinra subcutaneously (SC) once daily (QD) on days 1-21 of each cycle, once every other day of each cycle, or once every 3 days of each cycle. Patients also receive tocilizumab intravenously (IV), nivolumab IV, and ipilimumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) or positron emission tomography (PET)/CT during screening and as clinically indicated as well as blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 1 week and then every 6 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) | Experimental | Biological: Anakinra, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic Health Record Review, Biological: Ipilimumab, Procedure: Magnetic Resonance Imaging, Biological: Nivolumab, Procedure: Positron Emission Tomography, Biological: TocilizumabPatients receive anakinra SC QD on days 1-21 of each cycle, once every other day of each cycle, or once every 3 days of each cycle. Patients also receive tocilizumab IV, nivolumab IV, and ipilimumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT or PET/CT during screening and as clinically indicated as well as blood sample collection throughout the study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 50 years old
- Patients with melanoma, who are going to be treated with ipilimumab 1mg/Kg and nivolumab 3mg/Kg as a standard of care (SOC)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Platelets ≥ 50 000/µL
- Hemoglobin ≥ 8.0 g/dL
Key exclusion criteria (7 listed)
- Patients must not be receiving other concomitant biologic therapy, targeted therapy, chemotherapy, other anti-cancer therapy or any other investigational agents while on this protocol
- Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first cycle
- Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements
- Positive pregnancy test, active pregnancy or nursing / breast-feeding, due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
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 |
|---|---|---|
| AnakinraAlso: Kinaret, Kineret, rIL-1ra, rIL1RNGiven SC | Biological | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT or PET/CT | Procedure or surgery | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| Electronic Health Record ReviewAncillary studies | Other | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| IpilimumabAlso: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016Given IV | Biological | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| NivolumabAlso: ABP 206, BCD-263, BMS 936558, BMS-936558Given IV | Biological | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
| TocilizumabAlso: Actemra, Avtozma, IL-6 receptor monoclonal antibodies: tocilizumab, Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, DimerGiven IV | Biological | Treatment (anakinra, tocilizumab, nivolumab, ipilimumab) |
Primary outcome
Tolerated dose of the combination of anakinra and tocilizumab that can be used in conjunction with nivolumab and ipilimumab in patients 50 years or older
Time frame: Up to 12 weeks
4 secondary outcomes
Incidence of discontinuation of immune checkpoint inhibitor therapy due to grade 3 or higher immune-related adverse events
Time frame: Up to 12 weeks
Objective response rate
Time frame: Up to 2 years
Overall survival
Time frame: From first dose of treatment to death due to any cause, assessed up to 2 years
Progression free survival (PFS)
Time frame: From start of treatment to time of progression or death whichever comes first, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
USC / Norris Comprehensive Cancer Center
Los Angeles, United States
Fumito Ito principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anakinra, Biospecimen Collection and Computed Tomography in people with Melanoma, run by University of Southern California at 1 site 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 12 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerated dose of the combination of anakinra and tocilizumab that can be used in conjunction with nivolumab and ipilimumab in patients 50 years or older (time frame: Up to 12 weeks). 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 24 Sep 2026.