Phase 1 Ramucirumab plus Pembrolizumab in different types of Cancer

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Phase 1 Study of Ramucirumab plus Pembrolizumab in Patients with Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

• IRAS ID

  183773

• Contact name

  Miriam Adesokan

• Contact email

  adesokan_miriam@network.lilly.com

• Sponsor organisation

  Eli Lily and Company

• Eudract number

  2015-001473-40

• Duration of Study in the UK

  1 years, 4 months, 1 days

• Research summary

  Study I4T-MC-JVDF is an open-label, multicenter Phase 1 study to evaluate the safety and efficacy of ramucirumab in combination with pembrolizumab. The study is divided in 2 phases: Phase 1a where the maximum dose (dose-limiting toxicity [DLT] will be evaluated and an Expansion Phase 1b where the safety and preliminary efficacy will be evaluated. The study will include patients with locally advanced and unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; non-small cell lung cancer (NSCLC); or transitional cell carcinoma of the urothelium (urothelial cancer). If sufficient tolerability and preliminary efficacy are demonstrated in Phase 1, the protocol will be amended to further evaluate efficacy and safety, and re-submitted accordingly.

• REC name

  London - South East Research Ethics Committee

• REC reference

  15/LO/1282

• Date of REC Opinion

  25 Aug 2015

• REC opinion

  Favourable Opinion