IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Part of paid clinical trials in Orange City, Florida.

Sponsor
IO Biotech
Study ID
NCT05155254
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • IO102-IO103 — DRUG
    IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously
  • Pembrolizumab — DRUG
    Pembrolizumab administered intravenously

Study Details

Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.

Key Dates

Start date
May 17, 2022
Status verified
May 2025
Primary completion
May 30, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
407 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IO102-IO103 + pembrolizumab
    IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment). Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.
  • Active Comparator: pembrolizumab
    Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Approximately 3.5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Roswell Park Cancer InstituteBuffaloNew York14221-
VCU Massey Cancer CenterRichmondVirginia23219-

Related coverage on Hipa.ai

Find similar trials in Orange City, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Mid Florida Hematology and Oncology Center· Orange City, FLOrlando Health Cancer Institute· Orlando, FLRoswell Park Cancer Institute· Buffalo, NYVCU Massey Cancer Center· Richmond, VA

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