NL-OMON53663尚未招募3 期
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 - IO102-IO103 and/or Pembrolizumab in Advanced Melanoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
- •- Other protocol defined inclusion criteria may apply.
排除标准
- •- 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
- •* 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
- •- 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.
研究者
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