The CCTG PA.7 phase II trial of gemcitabine and nab-paclitaxel with or without durvalumab and tremelimumab as initial therapy in metastatic pancreatic ductal adenocarcinoma Journal Articles uri icon

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  • AbstractImmunotherapy-based monotherapy treatment in metastatic pancreatic ductal adenocarcinoma (mPDAC) has shown limited benefit outside of the mismatch repair deficiency setting, while safety and efficacy of combining dual-checkpoint inhibitor immunotherapy with chemotherapy remains uncertain. Here, we present results from the CCTG PA.7 study (NCT02879318), a randomized phase II trial comparing gemcitabine and nab-paclitaxel with and without immune checkpoint inhibitors durvalumab and tremelimumab in 180 patients with mPDAC. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and objective response rate. Results of the trial were negative as combination immunotherapy did not improve survival among the unselected patient population (p = 0.72) and toxicity was limited to elevation of lymphocytes in the combination immunotherapy group (p = 0.02). Exploratory baseline circulating tumor DNA (ctDNA) sequencing revealed increased survival for patients with KRAS wildtype tumors in both the combination immunotherapy (p = 0.001) and chemotherapy (p = 0.004) groups. These data support the utility of ctDNA analysis in PDAC and the prognostic value of ctDNA-based KRAS mutation status.


  • Renouf, Daniel J
  • Loree, Jonathan M
  • Knox, Jennifer J
  • Topham, James T
  • Kavan, Petr
  • Jonker, Derek
  • Welch, Stephen
  • Couture, Felix
  • Lemay, Frederic
  • Tehfe, Mustapha
  • Harb, Mohammed
  • Aucoin, Nathalie
  • Ko, Yoo-Joung
  • Tang, Patricia A
  • Ramjeesingh, Ravi
  • Meyers, Brandon
  • Kim, Christina A
  • Du, Pan
  • Jia, Shidong
  • Schaeffer, David F
  • Gill, Sharlene
  • Tu, Dongsheng
  • O’Callaghan, Chris J

publication date

  • August 26, 2022