At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed esophageal or gastroesophageal cancer
- ✓No prior chemotherapy for this malignancy
- ✓ECOG performance status 0 or 1
- ✓Life expectancy greater than 4 months
- ✕Active or prior inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- ✕History of allogeneic organ transplant
- ✕Uncontrolled intercurrent illness including active infection, symptomatic heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmia, active peptic ulcer or gastritis, active bleeding, acute/chronic hepatitis B or C, HIV, or immunodeficiency
- ✕History of tuberculosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer
In Brief
A Phase 2 clinical trial evaluating Durvalumab, Tremelimumab, and 8 other interventions for Esophageal Cancer. Completed, enrolled 73 participants across 4 sites.
Detailed Summary
This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable OC. The immunotherapy will be given for a 4-week period before starting the standard chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2 (Cohorts B, C, C-FLOT, D/D2).
Study Details
Timeline
Interventions
Anti PD-L1 antibody
Anti CTLA-4 antibody
IV administered chemotherapy
orally-administered chemotherapy
IV administered chemotherapy
IV administered Chemotherapy
IV administered chemotherapy
chemo-protective agent
IV administered chemotherapy