Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study).
Clinical cancer research : an official journal of the American Association for Cancer Research
Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Pancreatic Neoplasms
PURPOSE: Limited options exist for patients with advanced pancreatic cancer progressing after 1 or more lines of therapy. A phase II study in patients with previously treated metastatic pancreatic cancer showed that combining GVAX pancreas (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated
PATIENTS AND METHODS: Patients with previously treated metastatic pancreatic adenocarcinoma were randomized 1:1:1 to receive Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy (arm C). The primary cohort included patients who had failed ≥2 prior lines of therapy, including gemcitabine. The primary objective compared OS between arms A and C in the primary cohort. The second-line cohort included patients who had received 1 prior line of therapy. Additional objectives included OS between all treatment arms, safety, and tumor responses.
RESULTS: The study did not meet its primary efficacy endpoint. At the final study analysis, median OS [95% confidence interval (CI)] in the primary cohort (
CONCLUSIONS: The combination of Cy/GVAX + CRS-207 did not improve survival over chemotherapy. (ClinicalTrials.gov ID: NCT02004262)
Le, Dung T; Picozzi, Vincent J; Ko, Andrew H; Wainberg, Zev A; Kindler, Hedy; Wang-Gillam, Andrea; Oberstein, Paul; Morse, Michael A; Zeh, Herbert J; Weekes, Colin; Reid, Tony; Borazanci, Erkut; Crocenzi, Todd S; LoConte, Noelle K; Musher, Benjamin; Laheru, Dan; Murphy, Aimee; Whiting, Chan; Nair, Nitya; Enstrom, Amanda; Ferber, Sandy; Brockstedt, Dirk G; and Jaffee, Elizabeth M, "Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study)." (2019). Articles, Abstracts, and Reports. 2174.