Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma

Sponsor
Canadian Cancer Trials Group
Study ID
NCT02879318
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The standard or usual treatment for this disease consists of two chemotherapy drugs gemcitabine and nab-paclitaxel given together.

Key Dates

Start date
Nov 7, 2016
Status verified
Mar 2025
Primary completion
Aug 3, 2020
Completion
Mar 14, 2025

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Survival [ Time Frame: 35 months ]

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