Randomized Phase 3 trial of IO102-IO103 (IDO-PD-L1) dual-antigen immunotherapeutic plus pembrolizumab versus pembrolizumab alone in unresectable or metastatic (advanced) melanoma

An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma.

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Caldwell, Chloe M; Donaldson, Karin M; Grofsik, Kiera

  • IRB No: S21.202.12

    Protocol Abbrev: IO102-IO103-013

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: KEYNOTE-D18/IO Biotech-IOB-01

    Treatment: Drug: IO102-IO103 Drug: Pembrolizumab

    Therapies Involved: Chemotherapy ID: NCT05155254

  • Objective

    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 (PFS).

    The secondary objectives are to further explore the efficacy of IO102-IO103 in combination with pembrolizumab compared with pembrolizumab alone in terms of ORR, DRR, CRR and OS and to investigate the safety and tolerability of the treatment.

  • Key Eligibility

    Inclusion Criteria:
    1. Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy.
    2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible:

    a. Patients with proto-oncogene B-Raf (BRAFV600) mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigator assessment.

    b. Patients who have received previous adjuvant and/or neoadjuvant therapy with targeted therapy or immune therapy are eligible if administered the last dose at least 6 months before inclusion in this trial (randomization), and if relapse did not occur during active treatment or within 6 months of treatment discontinuation.

    3. At least 1 measurable lesion (not a cutaneous lesion) according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC.

    4. Provision of archival (obtained within 3 months), or newly acquired biopsy tissue not previously irradiated, and blood at screening for biomarker assessments. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.