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Combining vaccines with standard drugs for treating advanced melanoma

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

PHASE2 · Memorial Sloan Kettering Cancer Center · NCT05912244

This study is testing whether adding the vaccines IO102/IO103 to standard melanoma treatments can help people with advanced melanoma feel better and improve their outcomes.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment43 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center (other)
Drugs / interventionsimmunotherapy, prednisone, nivolumab, relatlimab
Locations9 sites (Hartford, Connecticut and 8 other locations)
Trial IDNCT05912244 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of the vaccines IO102/IO103 when used alongside the standard treatment regimen of nivolumab and relatlimab in patients with untreated, unresectable melanoma. Participants must have a confirmed diagnosis of locally advanced or metastatic melanoma and have not received prior systemic therapy for their condition. The study aims to assess the response of measurable melanoma lesions to this combination therapy. The research is being conducted at multiple locations affiliated with Memorial Sloan Kettering Cancer Center.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable stage III or IV melanoma who have not received prior systemic therapy.

Not a fit: Patients with resectable melanoma or those who have previously undergone systemic therapy for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 years at the time of informed consent
2. Patient must be able to provide informed consent.
3. Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy.
4. 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.
5. 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.
6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
7. Adequate laboratory function at screening, defined as:

   1. Hemoglobin ≥ 9.0 g/dL
   2. WBC ≥ 2000/uL
   3. Platelet count ≥ 100 × 10\^9 /L
   4. 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)
   5. Calculated creatinine clearance (CrCl) ≥15 mL/min based on the Cockcroft-Gault equation
8. 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).
9. 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.

Exclusion Criteria:

1. Uveal melanoma
2. Untreated central nervous system (CNS) metastases or any leptomeningeal involvement. Asymptomatic brain metastases that have been treated with external radiotherapy are permitted.
3. 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.
4. 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)

Where this trial is running

Hartford, Connecticut and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Melanoma, IO102/IO103, Nivolumab, Relatlimab, Unresectable, Stage III/IV, 23-098

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.