NCT06062420进行中（未招募）2 期
A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 316
- 试验地点
- 108
- 主要终点
- Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
研究概览
简要总结
The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically or cytologically-confirmed HNSCC that is R/M and is considered incurable by local therapies. A) Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed B) The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primary tumor site of nasopharynx (any histology)
- •Has measurable (target) disease based on RECIST 1.1 as determined by the investigator.
- •Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. A fresh tumor tissue sample obtained within 90 days of screening is highly preferred, If fresh biopsy is not possible, an archival tumor specimen is acceptable unless it was obtained prior to administration of chemoradiation for the treatment of a participant's tumor. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable.
- •Has tumor Programmed death ligand 1 (PD-L1) expression
- •If the primary tumor site is oropharyngeal carcinoma, the participant must have Human papillomavirus (HPV) results
排除标准
- •Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine based inhibitory motif domains (TIGIT), Cluster of differentiation (CD) 96, or other immune checkpoint pathways.
- •Participants with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
- •Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major vessel [carotid, jugular, bronchial artery] and/or exhibits other high-risk features such as arteriovenous fistula).
- •Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC
- •Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastases
- •Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. (Stable, medically managed autoimmune endocrinopathies are acceptable if participant otherwise meets entry criteria.)
研究组 & 干预措施
Sub study 4: Dostarlimab and remzistotug
Experimental
干预措施: Remzistotug (Drug)
Sub study 3: Dosarlimab and Belrestotug and nelistotug
Experimental
干预措施: Nelistotug (Drug)
Sub study 4: Dostarlimab and remzistotug
Experimental
干预措施: Dostarlimab (Drug)
Sub study 1: Dostarlimab and Belrestotug
Experimental
干预措施: Belrestotug (Drug)
Sub study 3: Dosarlimab and Belrestotug and nelistotug
Experimental
干预措施: Dostarlimab (Drug)
Dostarlimab Monotherapy
Experimental
干预措施: Dostarlimab (Drug)
Sub study 1: Dostarlimab and Belrestotug
Experimental
干预措施: Dostarlimab (Drug)
Sub study 2: Dostarlimab and nelistotug
Experimental
干预措施: Dostarlimab (Drug)
Sub study 3: Dosarlimab and Belrestotug and nelistotug
Experimental
干预措施: Belrestotug (Drug)
Sub study 2: Dostarlimab and nelistotug
Experimental
干预措施: Nelistotug (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
时间窗: Up to approximately 24 months
Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
次要结局
- Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)(Up to approximately 24 months)
- Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation(Up to approximately 24 months)
- Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters(Up to approximately 24 months)
- Rate of Circulating Tumor Deoxyribonucleic Acid (ctDNA) Molecular Response(Up to approximately 24 months)
- Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)(Up to approximately 24 months)
- Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation(Up to approximately 24 months)
- Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters(Up to approximately 24 months)
研究者
研究点 (108)
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