NL-OMON52820已完成2 期
A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (study 209229) - 209229 (INDUCE-3)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
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
- •Age >=18 years.
- •Histological or cytological documentation of HNSCC that was diagnosed as
- •recurrent or metastatic and considered incurable by local therapies.
- •Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
- •No prior systemic therapy administered in the recurrent or metastatic
- •setting. See protocol chapter 5.1, item 5 for exceptions.
- •Measurable disease.
- •ECOG 0 or 1.
- •Adequate organ function. See protocol chapter 5.1, item 8 for details.
- •Life expectancy at least 12 weeks.
- •Contraception for females and males as stated in chapter 5.1 items 10-11 of
- •the protocol.
- •Tumor tissue at screening as defined in chapter 5.1 item 12 of the protocol.
- •PD-L1 IHC CPS >=1 status. See also chapter 5.1 item 13 of the protocol.
- •Have results from testing of HPV status for oropharyngeal cancer
排除标准
- •Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent.
- •Systemic anticancer therapy within 30 days or 5 half-lives of the drug,
- •whichever is shorter.
- •High risk of bleeding. See protocol chapter 5.2, item 3 for details.
- •Active tumor bleeding.
- •Grade 3/4 hypercalcemia.
- •Transfusion of blood products or administration of CSF within 14 days prior
- •to randomization. See protocol chapter 5.2, item 8 for details.
- •CNS metastases. See protocol chapter 5.2, item 9 for details.
- •Autoimmune disease or syndrome that required systemic treatment within the
- •past 2 years. See protocol chapter 5.2, item 11 for details.
- •Immunodeficiency or systemic steroids (>=10 mg oral prednisone per day or
- •equivalent) or other immunosuppressive agents within 7 days prior to
- •randomization. See protocol chapter 5.2, item 12 for details.
- •Live vaccine within 30 days prior randomization.
- •Prior allogeneic/autologous bone marrow or solid organ transplantation.
- •Pneumonitis or history of non-infectious pneumonitis that required steroids
- •or other immunosuppressive agents. See protocol chapter 5.2, item 15 for
- •Gastrointestinal problems in the past 6 months. See protocol chapter 5.2,
- •item 17 for details.
- •Allergen desensitization therapy within 4 weeks of randomization.
- •Cardiac abnormalities within the 6 months prior to randomization. See
- •protocol chapter 5.2, item 19 for details.
- •Cirrhosis or current unstable liver or biliary disease. See protocol chapter
- •5.2, item 20 for details.
- •Pregnant, breastfeeding, or planning to become pregnant or father children
- •during the study treatment or within 120 days after the last dose of study
研究者
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