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
- Conditions
- melanomaSkin cancer10040900
- Registration Number
- NL-OMON53663
- Lead Sponsor
- IO Biotech ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
- 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.
- 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 (<=2 weeks
of radiotherapy) to non-CNS disease.
- Patients with BRAFV600-positive disease who are experiencing rapidly
progressing disease and/or have received standard first-line therapy with BRAF
and/or MEK inhibitor for unresectable or metastatic disease
- Received a live or live-attenuated vaccine within 30 days before the first
dose of trial treatment. Patients are also prohibited from receiving live or
attenuated vaccine(s) throughout the duration of protocol therapy and/or within
90 days of the last dose of protocol therapy. Administration of killed
vaccines, mRNA based (e.g., covid-19) and vector-based vaccines are allowed.
- Other protocol defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PFS, defined as the time from randomization to the first documented disease<br /><br>progression (based on Independent Review Committee (IRC) in accordance with<br /><br>RECIST v1.1) or death from any cause. Patients who have not progressed or died<br /><br>at the time of analysis will be censored at the date of assessment from their<br /><br>last disease assessment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Overall Response Rate (ORR) defined as the percentage of patients achieving a<br /><br>confirmed partial response (PR) or confirmed complete response<br /><br>(CR). ORR will be determined by the IRC in accordance with RECIST v1.1.<br /><br>• OS, defined as the time from randomization until death from any cause.<br /><br>Patients not known to have died will be censored at the date they were last<br /><br>known to be alive<br /><br>• Duration of Response (DoR) based on IRC<br /><br>• Time to Response (TTR) based on IRC<br /><br>• Time to Complete Response (TTCR) based on IRC<br /><br>• Disease Control Rate (DCR) based on IRC<br /><br>• PFS and ORR, which will be assessed by the investigator according to RECIST<br /><br>v1.1</p><br>