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

Summary

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

Timeline

Start

2016-11-07

Primary completion

2020-08-03

Completion

2025-03-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Gemcitabine Plus Nab-Paclitaxel vs Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab; p = 0.72 NCT02879318 ↗

paper Results of the trial were negative as combination immunotherapy did not improve survival among the unselected patient population (p = 0.72) PMID 36028483 ↗

Publications

• Results Renouf DJ, Loree JM, Knox JJ, Topham JT, Kavan P, Jonker D, Welch S, Couture F, Lemay F, Tehfe M, Harb M, Aucoin N, Ko YJ, Tang PA, Ramjeesingh R, Meyers BM, Kim CA, Du P, Jia S, Schaeffer DF, Gill S, Tu D, O'Callaghan CJ. 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. Nat Commun. 2022 Aug 26;13(1):5020. doi: 10.1038/s41467-022-32591-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	75 mg	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Nab-paclitaxel	Small molecule	125 mg/m2	Intravenous

Indications