Celldex Therapeutics announced that the first patient has been screened in a randomized Phase 2 study of CDX-1307 in patients with newly diagnosed muscle-invasive bladder cancers that express hCG-beta. This study will enroll approximately 60 patients, randomized (1:1), with newly diagnosed hCG-beta expressing muscle-invasive bladder cancer who have not previously received any chemotherapy for their disease. Following screening with an hCG-beta diagnostic assay, patients will be randomized (1:1) to receive neoadjuvant therapy with either CDX-1307 and standard of care chemotherapy (gemcitabine and cisplatinum) or standard of care alone, and will then undergo the previously planned bladder resection. Following bladder resection, patients administered neoadjuvant therapy will also receive adjuvant CDX-1307 vaccine for up to one year. Patients will be evaluated for: (1) pathologic complete response in resected tumors after neoadjuvant therapy and Relapse Free Survival at two years after infiltration; (2) immune response, safety and anti hCG-beta effects on resected tumor, including hCG-beta expression and immune infiltration; and (3) Overall Survival (OS).
CDX-1307 vaccine is a fully human monoclonal antibody designed to selectively deliver the hCG-beta antigen to dendritic cells.
For more information call (781) 433-0771 or visit www.celldextherapeutics.com.