At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 180 enrolled
Drug / intervention
Gemcitabine +3 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
- ✓Measurable or evaluable disease by RECIST 1.1
- ✓Suitable candidate for first-line gemcitabine and nab-paclitaxel chemotherapy
- ✓Age ≥18 years
Key exclusion· 9
- ✕Prior treatment with PD-1/PD-L1 inhibitor (including durvalumab) or anti-CTLA4 (including tremelimumab)
- ✕History of primary immunodeficiency, organ transplant requiring immunosuppression, or grade 3-4 immune-mediated toxicity from prior immune therapy
- ✕Immunosuppressive medication within 28 days prior to first dose (except inhaled/intranasal corticosteroids or systemic corticosteroids ≤10 mg/day prednisone equivalent)
- ✕Active or prior autoimmune/inflammatory disorders within 3 years (except stable hypothyroidism, vitiligo/Grave's disease/psoriasis not requiring systemic treatment within 2 years, alopecia)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, Nab-paclitaxel, and 2 other interventions for Pancreatic Adenocarcinoma. Completed, enrolled 180 participants across 27 sites.
Detailed Summary
The standard or usual treatment for this disease consists of two chemotherapy drugs gemcitabine and nab-paclitaxel given together.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Adenocarcinoma
CountriesCanada
CollaboratorsAstraZeneca
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartNov 2016
Primary CompletionAug 2020
Study CompletionMar 2025
TodayJul 2026
First PostedAug 25, 2016
Enrollment StartNov 7, 2016
Primary CompletionAug 3, 2020
Study CompletionMar 14, 2025
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.9 years ago
Interventions
Gemcitabinedrug
Nab-paclitaxeldrug
Durvalumabdrug
Tremelimumabdrug