EUCTR2017-000241-49-DE进行中（未招募）1 期
A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 416
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically documented advanced or metastatic solid tumors or
- •a.Part 1: renal cell carcinoma (RCC), pancreatic cancer,urothelial cancer,head and neck squamous cell carcinoma (HNSCC),diffuse large B-cell lymphoma (DLBCL),microsatellite stable colorectal cancer (MSS CRC),triple negative breast cancer (TNBC) melanoma or mCRPC
- •b.Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC.For those with mixed histology, there must be a predominant histology
- •c.Part 3:histologically confirmed diagnosis of advanced/metastatic malignancies should Part 3 be opened to enrollment.As of protocol amendment 6, Part 3 will be opened to further assess TNBC patients
- •with a PD-L1 SP-142 IC score of 0 (<1%).A second tumor group will be
- •considered for Part 3 after completion of Part 1
- •2.Patient must have a site of disease amenable to biopsy and be a
- •candidate for tumor biopsy according to the treating institution's
- •guidelines.Patient must be willing to undergo a new tumor biopsy at
- •screening, and again during therapy
- •3.Patients (other than those with DLBCL) must previously have received at least 1 and no more than 3 prior lines of therapy for their disease:
- •MSS CRC: -Patients with MSS CRC must have received(or be intolerant to) prior therapy with fluoropyrimidine-oxaliplatin- and irinotecan- based regimens
- •-Patient with wt RAS must have received prior treatment with an
- •antibody targeting EGFR (e.g. cetuximab or panitumumab)
- •TNBC: Part 1:
- •-Patients with TNBC must have received a prior taxane-containing
- •-Patients should have documented disease progression following,or
- •intolerance to, no more than 2 prior lines of chemotherapy for advanced or metastatic disease.Neoadjuvant and/or adjuvant chemotherapy administered with curative intent will count as one prior line of therapy, if disease recurred within 12 months of the last treatment
- •-Patients must have received prior systemic treatment that included
- •taxane-based chemotherapy for(neo) adjuvant or metastatic disease
- •-Patients should have a known PD-L1 status as per local available testing determined by VENTANA PD-L1 SP142 Assay with IC score of 0 (<1%)
- •Urothelial Cancer:
- •-Patients with urothelial cancer must have received a prior platinum containing regimen or be ineligible for cisplatin
- •-IO Naive: Patients with RCC must have received a prior VEGF tyrosine
- •kinase inhibitor(TKI)
- •-IO pre-treated: Patients with RCC with no more than 2 prior lines of
- •therapy. Patient must have received a prior VEGF TKI and have been
- •pretreated with an anti-PD-1/PD-L1 as a single agent or in combination
- •-I/O Naive:Patients with HNSCC with no more than 3 prior lines of
- •therapy; must have received a prior platinum-containing regimen and
- •have not been previously treated with any anti-PD1/L1 agents in single agent/combinations
- •-I/O pre-treated: Patients with HNSCC with no more than 2 prior lines of therapy; must have received a prior platinum-containing regimen and have been pretreated with an anti-PD-1/PD-L1 as a single agent or in combinations
- •Cutaneous Melanoma
- •-Patients must previously have received at least 1 and no more than 2
- •prior lines of therapy
- •-BRAF V600E wild type patients: must have received anti-PD-1/PD-L1
- •single-agent, or in combination with anti-CTLA-4 therapy
- •-BRAF V600E mutant patients: must have received prior anti-PD-1/PD-L1 single-agent, or in combination with anti-CTLA-4 therapy. In addition, subjects must
排除标准
- •- Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR inhibitors for non-oncologic indications (e.g. Parkinson’s disease) may be considered for enrollment on a case by case basis.
- •- Current or prior use of immunosuppressive medication within 28 days before the first dose of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of prednisone)
- •- History of interstitial lung disease or non-infectious pneumonitis
- •- History of another primary malignancy except for:
- •. Malignancy treated with curative intent and with no known active disease =2 years before the first dose of study drug and of low potential risk for recurrence
- •. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •. Adequately treated carcinoma in situ without evidence of disease
- •- Active or prior documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- •- More than 2 or 3 prior lines of therapy as indicated for each tumor type in the inclusion criteria 4
- •- Participation in another clinical study with an investigational product during the last 21 days prior to starting on treatment.
- •Other protocol defined exclusion criteria may apply.
研究者
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