| Title: |
Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial |
| Authors: |
Weller, Michael; Butowski, Nicholas; Tran, David D; Recht, Lawrence D; Lim, Michael; Hirte, Hal; Ashby, Lynn; Mechtler, Laszlo; Goldlust, Samuel A; Iwamoto, Fabio; Drappatz, Jan; O'Rourke, Donald M; Wong, Mark; Hamilton, Mark G; Finocchiaro, Gaetano; Perry, James; Wick, Wolfgang; Green, Jennifer; He, Yi; Turner, Christopher D; Yellin, Michael J; Keler, Tibor; Davis, Thomas A; Stupp, Roger; Sampson, John H; investigators, ACT IV trial; Campian, Jian; Recht, Lawrence; Goldlust, Samuel; Becker, Kevin; Barnett, Gene; Nicholas, Garth; Desjardins, Annick; Benkers, Tara; Wagle, Naveed; Groves, Morris; Kesari, Santosh; Horvath, Zsolt; Merrell, Ryan; Curry, Richard; O'Rourke, James; Schuster, David; Mrugala, Maciej; Jensen, Randy; Trusheim, John; Lesser, Glenn; Belanger, Karl; Sloan, Andrew; Purow, Benjamin; Fink, Karen; Raizer, Jeffrey; Schulder, Michael; Nair, Suresh; Peak, Scott; Brandes, Alba; Mohile, Nimish; Landolfi, Joseph; Olson, Jon; Jennens, Ross; DeSouza, Paul; Robinson, Bridget; Crittenden, Marka; Shih, Kent; Flowers, Alexandra; Ong, Shirley; Connelly, Jennifer; Hadjipanayis, Costas; Giglio, Pierre; Mott, Frank; Mathieu, David; Lessard, Nathalie; Sepulveda, Sanchez Juan; Lövey, József; Wheeler, Helen; Inglis, Po-Ling; Hardie, Claire; Bota, Daniela; Lesniak, Maciej; Portnow, Jana; Frankel, Bruce; Junck, Larry; Thompson, Reid; Berk, Lawrence; McGhie, John; Macdonald, David; Saran, Frank; Soffietti, Riccardo; Blumenthal, Deborah; de, Sá Barreto Costa Marcos André |
| Source: |
The Lancet Oncology, vol 18, iss 10 |
| Publisher Information: |
eScholarship, University of California |
| Publication Year: |
2017 |
| Collection: |
University of California: eScholarship |
| Subject Terms: |
32 Biomedical and Clinical Sciences (for-2020); 3202 Clinical Sciences (for-2020); 3211 Oncology and Carcinogenesis (for-2020); Clinical Research (rcdc); Clinical Trials and Supportive Activities (rcdc); Rare Diseases (rcdc); Neurosciences (rcdc); Cancer (rcdc); Brain Disorders (rcdc); Brain Cancer (rcdc); 6.1 Pharmaceuticals (hrcs-rac); Cancer (hrcs-hc); Adult (mesh); Aged (mesh); Antineoplastic Combined Chemotherapy Protocols (mesh); Brain Neoplasms (mesh); Cancer Vaccines (mesh); Dacarbazine (mesh); Disease-Free Survival (mesh); Dose-Response Relationship; Drug (mesh); Double-Blind Method (mesh); Drug Administration Schedule (mesh); ErbB Receptors (mesh); Female (mesh); Follow-Up Studies (mesh); Gene Expression Regulation; Neoplastic (mesh); Glioblastoma (mesh); Humans (mesh) |
| Time: |
1373 - 1385 |
| Description: |
BACKGROUND: Rindopepimut (also known as CDX-110), a vaccine targeting the EGFR deletion mutation EGFRvIII, consists of an EGFRvIII-specific peptide conjugated to keyhole limpet haemocyanin. In the ACT IV study, we aimed to assess whether or not the addition of rindopepimut to standard chemotherapy is able to improve survival in patients with EGFRvIII-positive glioblastoma. METHODS: In this randomised, double-blind, phase 3 trial, we recruited patients aged 18 years and older with glioblastoma from 165 hospitals in 22 countries. Eligible patients had newly diagnosed glioblastoma confirmed to express EGFRvIII by central analysis, and had undergone maximal surgical resection and completion of standard chemoradiation without progression. Patients were stratified by European Organisation for Research and Treatment of Cancer recursive partitioning analysis class, MGMT promoter methylation, and geographical region, and randomly assigned (1:1) with a prespecified randomisation sequence (block size of four) to receive rindopepimut (500 μg admixed with 150 μg GM-CSF) or control (100 μg keyhole limpet haemocyanin) via monthly intradermal injection until progression or intolerance, concurrent with standard oral temozolomide (150-200 mg/m2 for 5 of 28 days) for 6-12 cycles or longer. Patients, investigators, and the trial funder were masked to treatment allocation. The primary endpoint was overall survival in patients with minimal residual disease (MRD; enhancing tumour |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
qt2sg9m5wp; https://escholarship.org/uc/item/2sg9m5wp; https://escholarship.org/content/qt2sg9m5wp/qt2sg9m5wp.pdf |
| DOI: |
10.1016/s1470-2045(17)30517-x |
| Availability: |
https://escholarship.org/uc/item/2sg9m5wp; https://escholarship.org/content/qt2sg9m5wp/qt2sg9m5wp.pdf; https://doi.org/10.1016/s1470-2045(17)30517-x |
| Rights: |
public |
| Accession Number: |
edsbas.5AC98BE8 |
| Database: |
BASE |