Phase II Trial Overview
Study Title: PADDLE
This trial investigates the combination of nab-paclitaxel, ramucirumab, and nivolumab for patients with advanced gastric cancer (AGC) who have not responded to previous treatments.
Background
Patients with AGC often have limited survival after initial treatments. New research suggests that continuing immunotherapy after disease progression can be beneficial. The combination of nab-paclitaxel, ramucirumab, and nivolumab may improve treatment outcomes for these patients.
Trial Details
The PADDLE trial is sponsored by Ono Pharmaceutical and involves multiple centers in Japan. Key points include:
- Participants must have advanced gastric or esophagogastric junction cancer.
- They should have a confirmed diagnosis of adenocarcinoma.
- Patients must have not responded to first-line treatments, including specific chemotherapy and anti-PD-1/PD-L1 therapies.
- They should have a performance status of 0-1 and at least one measurable tumor.
Participants will receive:
- nab-paclitaxel (100 mg/m2 weekly)
- ramucirumab (8 mg/kg every 2 weeks)
- nivolumab (240 mg every 2 weeks)
The main goal is to assess the 6-month progression-free survival (PFS) rate, with a target of 45 patients enrolled.
Expected Outcomes
This trial aims to determine the effectiveness of the triplet therapy and identify biomarkers that may predict patient responses.
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