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MelanomaPhase 2NCT05912244

A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma

A Phase 2 study testing IO102/IO103 and Nivolumab-Relatlimab in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The researchers are doing this study to find out whether the study vaccines, IO102/IO103, given in combination with the standard-of-care drug combination, nivolumab and relatlimab, is a safe and effective treatment for people with untreated, unresectable melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
IO102/IO103 and Nivolumab-Relatlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
9 sitesUnited States
Study dates
9 Jun 2023to 9 Jun 2027
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of informed consent
  • Patient must be able to provide informed consent.
  • Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy.
  • Patient must have not received any prior systemic therapy directed against unresectable stage III or IV melanoma. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK inhibitors are permitted as long as the last dose was > 6 months prior to recurrence.
  • Patients must have at least one extraskeletal, extracranial measurable melanoma lesion as defined by RECIST v1.1. Note: A formal RECIST read by a study radiologist is not needed at the time of enrollment. Measurable disease can be assessed by the treating investigator.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
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  • Adequate laboratory function at screening, defined as:
  • Hemoglobin ≥ 9.0 g/dL
  • WBC ≥ 2000/uL
  • Platelet count ≥ 100 × 10^9 /L
  • Serum direct bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN. (Total bilirubin < 3 mg/dL for subjects with Gilbert's disease)
  • Calculated creatinine clearance (CrCl) ≥15 mL/min based on the Cockcroft-Gault equation
  • Patients of childbearing potential* who are sexually activ partner must use two methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product: cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
  • Patients of childbearing potential are defined as those who are assigned female at birth and not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
  • Male patients who are sexually active with partners of childbearing potential must use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period.

Who cannot join

  • Uveal melanoma
  • Untreated central nervous system (CNS) metastases or any leptomeningeal involvement. Asymptomatic brain metastases that have been treated with external radiotherapy are permitted.
  • Any immunotherapy treatment for unresectable stage III/IV melanoma or any other prior unresectable malignancy. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK inhibitors are permitted as long as the last dose was > 6 months prior to recurrence.
  • Systemic steroid therapy higher than physiologic dose steroid replacement (>10 mg/day of prednisone or equivalent), given within 14 days of starting treatment, or other immunosuppressive medications within 14 days of the start of treatment. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. 5. Treatment with any live/attenuated vaccine within 30 days of first study treatment. Inactivated and mRNA vaccines are permitted.
  • 6. History of motor neuropathy considered to be of autoimmune origin to be of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis) 7. Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator 8. History of severe allergic reactions to any unknown allergens or any components of the study drugs.
  • 9. Uncontrolled (i.e., unstable) concomitant medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety or compliance with the study procedures. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 10. Active hepatitis B virus (HBV) with a viral load >100 IU/mL 11. Active hepatitis C virus (HCV) with a viral load >100 IU/mL 12. Patients who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug.
  • 13. Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific circumstances where local regulations permit, a person who has been imprisoned may be permitted to continue as a participant.) 14. Participants who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g., transmissible infection)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Lehigh Valley Health Network (Data Collection Only)

    Allentown, Pennsylvania, 18103

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

  • Hartford Healthcare Alliance (Data Collection Only)

    Hartford, Connecticut, 06102

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase II Study of IO102/IO103 and Nivolumab-relatlimab Fixed Dose Combination in Untreated, Unresectable Stage III/IV Melanoma

The researchers are doing this study to find out whether the study vaccines, IO102/IO103, given in combination with the standard-of-care drug combination, nivolumab and relatlimab, is a safe and effective treatment for people with untreated, unresectable melanoma.

Conditions
Melanoma
Being tested
IO102/IO103, Nivolumab-Relatlimab
Keywords
IO102/IO103, Nivolumab, Relatlimab, Unresectable, Stage III/IV, 23-098
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IO102/IO103Drug

    IO102/IO103 will be administered subcutaneously on Days 1 and 15 of the first two 28-day cycles, and then on Day 1 only of subsequent cycles for two total years of treatment. Each vaccine contains 85ug.

  • Nivolumab-RelatlimabDrug

    Nivolumab-relatlimab will be administered as a single infusion 160mg relatlimab and nivolumab 480 mg for all participants. Both agents will be combined in a single fixed-dose combination (FDC) as an intravenous 30-minute infusion every four weeks.

Study groups in NCT05912244
Study groupRoleWhat they receive
IO102/IO103, Nivolumab, and RelatlimabExperimentalAll patients will be treated with nivolumab-relatlimab FDC on Day 1 of every 28-day cycle for up to two years. Patients will be treated with IO102/IO103 on Days 1 and 15 of the first two 28-day cycles, then on Day 1 of subsequent cycles for up to two total years of treatment.
Receives: Drug: IO102/IO103; Drug: Nivolumab-Relatlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    will be reported as the proportion of patients who experience a complete (CR) or partial response (PR) to treatment by RECIST v1.1

    Measured: 3 years

Secondary outcomes (2)

  1. Incidence of adverse events

    graded and recorded according to CTCAE v5.0

    Measured: up to 100 days after the last dose

  2. Progression-free survival (PFS)

    by RECIST v1.1

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start9 Jun 2023
  3. Primary completion9 Jun 2027 (estimated)
  4. Study completion9 Jun 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Sequentially in a single-arm, nonrandomized two-stage trial design
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912244
Sponsor's protocol ID
23-098
Status last verified
May 2026
First submitted
12 Jun 2023
Last updated
1 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Kjeldsen JW, Lorentzen CL, Martinenaite E, Ellebaek E, Donia M, Holmstroem RB, Klausen TW, Madsen CO, Ahmed SM, Weis-Banke SE, Holmstrom MO, Hendel HW, Ehrnrooth E, Zocca MB, Pedersen AW, Andersen MH, Svane IM. A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma. Nat Med. 2021 Dec;27(12):2212-2223. doi: 10.1038/s41591-021-01544-x. Epub 2021 Dec 9.

    PubMed 34887574

  • Lorentzen CL, Kjeldsen JW, Ehrnrooth E, Andersen MH, Marie Svane I. Long-term follow-up of anti-PD-1 naive patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab. J Immunother Cancer. 2023 May;11(5):e006755. doi: 10.1136/jitc-2023-006755.

    PubMed 37217243

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IO102/IO103 and Nivolumab-Relatlimab in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 9 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 15 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

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?

Overall Response Rate (ORR) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05912244, which also lists 2 linked publications.

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 1 Jun 2026.

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