drugset / Trial / NCT04069273

Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma

NCT04069273 ↗

Phase 2 Active not recruiting 58 enrolled Harry H Yoon Mayo Clinic · collabMerck Sharp & Dohme LLC · collab
RandomizedSequentialOpen-labelTreatment

Summary

Cohort 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions. Cohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.

Timeline

Start
2020-12-01
Primary completion
2027-08-11
Completion
2027-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 90 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Ramucirumab Monoclonal antibody 10 mg/kg Intravenous