Mahipal, Amit
Ejadi, Samuel
Gnjatic, Sacha
Kim-Schulze, Seunghee
Lu, Hailing
ter Meulen, Jan H.
Kenney, Richard
Odunsi, Kunle
Article History
Received: 29 January 2018
Accepted: 24 March 2019
First Online: 8 May 2019
Compliance with ethical standards
:
: Hailing Lu, Richard Kenney, and Jan ter Meulen are full-time employees and shareholders of Immune Design Corp. Sacha Gnjatic has received research support from Immune Design Corp. The authors declare that there are no other conflicts of interest.
: This trial is registered in the USA under the ClinicalTrials.gov identifier (NCT number): NCT02015416. Institutional Review Boards (IRBs) reviewed and approved the protocol, all protocol amendments, informed consent documents, and written study materials before their use.
: Roswell Park Cancer Institute (sponsor protocol #IDC-G305-2013-001 and RPCI protocol # PH 244813); Scottsdale Healthcare (WIRB Protocol Number: 20131768; WIRB Study Number: 1142287); Karmanos Cancer Institute (WIRB Protocol Number: 20131768; WIRB Study Number: 1143287); H. Lee Moffitt Cancer Ctr & Research Inst, Inc. (sponsor protocol #IDC-G305-2013-001–MCC 17622). The Karmanos Cancer Institute did not identify suitable patients to enroll on the trial.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: All patients provided informed consent prior to study enrollment at the screening visit. Patients also agreed on the use of patient data for research and publication.