Phase 2 Study of Novel SEQUEnced Immunotherapy (Pembrolizumab) With Anti-angiogenesis and Chemotherapy in Advanced Gastric and gastroesophageaL Junction (GEJ) Adenocarcinoma
Harry H Yoon
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Age ≥ 18 years at the time of consent. * ECOG Performance Status (PS) of 0-1within 28 days prior to registration. NOTE: Within 0-3 days prior to the anticipated C1D1, ECOG PS must be 0-1. * Tumor tissue must be obtained from a biopsy performed either (a) prior to registration or (b) prior to C1D1, as described below. * Prior to registration: if a biopsy was perform…
Interventions
- DrugPembrolizumab Monotherapy
Pembrolizumab 200 mg IV
- DrugRamucirumab
Ramucirumab 10 mg/kg IV
- DrugPaclitaxel
Paclitaxel 90 mg/m2 IV
Locations (2)
- Mayo Clinic- MinnesotaRochester, Minnesota
- Froedtert and The Medical College of WisconsinMilwaukee, Wisconsin