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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05912244
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IO102/IO103 — DRUG
    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-Relatlimab — DRUG
    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 Details

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.

Key Dates

Start date
Jun 9, 2023
Status verified
May 2026
Primary completion
Jun 9, 2027
Completion
Jun 9, 2027

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IO102/IO103, Nivolumab, and Relatlimab
    All 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.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 3 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Hartford Healthcare Alliance (Data Collection Only)HartfordConnecticut06102-
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553-
Lehigh Valley Health Network (Data Collection Only)AllentownPennsylvania18103-

Find similar trials in Hartford, CT

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Hartford Healthcare Alliance (Data Collection Only)· Hartford, CTMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NY

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