Durvalumab(MEDI4736)/tremelimumab plus paclitaxel in patients with hypermutated gastric cancer who fail a first-line chemotherapy
- Conditions
- Neoplasms
- Registration Number
- KCT0004533
- Lead Sponsor
- Asan Medical Center
- Brief Summary
The combination chemotherapy of durvalumab, tremelimumab, and paclitaxel showed encouraging efficacy, especially in mGC with TMB >20/Mb or MSI-high mGC, as a second-line chemotherapy with manageable toxicities in biomarker-selected mGC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1.Have histologically- or cytologically- confirmed diagnosis of metastatic gastric carcinoma.
2.Have a performance status of 0-1 on the ECOG Performance Scale.
3.(for the phase II section) Have either CD274 amplification or a hypermutation or EBV positive
4.(for the phase II section) Have at least one investigator-assessed measurable disease per RECIST v1.1
5.Have failed a first-line fluoropyrimidine/platinum-containing chemotherapy for metastatic disease.
6.Have adequate organ functions
1.Prior immunotherapy, vaccine trial, or taxane therapy for gastric cancer
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, except for dexamethasone used for paclitaxel premedication
3.Uncontrolled CNS metastasis
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety;Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival;Duration of response;Overall survival