melanoma Skin cancer
Conditions
Interventions
Group 1: IO102-IO103: SC administration (IO102 85 µg and IO103 85 µg Q3W in
combination with pembrolizumab (IV administration 200 mg Q3W).
Group 2: Pembrolizumab: IV administration (200 mg Q3W).
Sponsors
IO Biotech ApS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 - Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible: - Patients with proto-oncogene B-Raf (BRAFV600) mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigator assessment. Documented BRAFV600 mutation status must be available from all patients prior to trial entry. - 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. - ECOG performance status score 0 or 1 assessed within 10 days before randomization - At least 1 measurable lesion (not a cutaneous lesion) according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC. - 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. - Patients are able and willing to provide written informed consent for the trial in accordance with ICH-GCP and local legislation before admission to the trial. - Other protocol defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: - Uveal/ocular, acral or mucosal melanoma - Patients with known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease are excluded with the following exception: * Patients with controlled (stable) brain metastases will be allowed to enroll (subject to baseline confirmation). Controlled (stable) brain metastases are defined as those with no radiographic progression for at least 4 weeks after radiation and/or surgical treatment at the time of signed informed consent. Patients must have been off steroids for at least 2 weeks before signed informed consent and have no new or progressive neurological signs and symptoms. - Patient has received previous radiotherapy within 2 weeks of start of trial treatment (visit 2). Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from randomization to the first documented disease progression (based on Independent Review Committee (IRC) in accordance with RECIST v1.1) or death from any cause. Patients who have not progressed or died at the time of analysis will be censored at the date of assessment from their last disease assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall Response Rate (ORR) defined as the percentage of patients achieving a confirmed partial response (PR) or confirmed complete response (CR). ORR will be determined by the IRC in accordance with RECIST v1.1. • OS, defined as the time from randomization until death from any cause. Patients not known to have died will be censored at the date they were last known to be alive • Duration of Response (DoR) based on IRC • Time to Response (TTR) based on IRC • Time to Complete Response (TTCR) based on IRC • Disease Control Rate (DCR) based on IRC • PFS and ORR, which will be assessed by the investigator according to RECIST v1.1 | — |
Countries
Netherlands
Outcome results
None listed