Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02879318|
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Gemcitabine Drug: Nab-paclitaxel Drug: Durvalumab Drug: Tremelimumab||Phase 2|
Durvalumab is a new type of drug for many types of cancer. Laboratory tests show that it works by allowing the immune system to detect cancer and reactivate the immune response. This may halp to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatments alone.
Tremelimumab is a new type of drug for various types of cancers. It works in a similar way to durvalumab and may improve the effect of durvalumab. This may also help slow the growth of the cancer cells or may cause cancer cells to die. Tremelimumab has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment alone when used with durvalumab.
Combination of durvalumab and tremelimumab have also been studied and when combined have been shown to increase tumour shrinkage in animals compared to either drug alone and while the combination has been studied in a few people, it is not clear if it can offer better results than standard treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||August 22, 2016|
|Actual Primary Completion Date :||August 3, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Active Comparator: Gemcitabine plus Nab-Paclitaxel
Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Experimental: Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
- Overall survival (Phase III) [ Time Frame: 35 months ]
- Progression free survival defined as the time from randomization to the first objective documentation of disease progression or death due to any cause [ Time Frame: 35 months ]
- Objective response rate defined as the proportion of patients with a documented complete response and partial response based on RECIST 1.1 [ Time Frame: 35 months ]
- Number and severity of adverse events [ Time Frame: 35 months ]The incidence of adverse events will be summarized by type of adverse event and severity using the NCI Common Terminology Criteria for Adverse Events. A Fisher's exact test will be used to compare adverse events between the two arms if required
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879318
|Study Chair:||Derek Jonker||Ottawa Hospital Research Institute, ON Canada|