A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)

CDX-1307 is an experimental vaccine that is designed to generate an immune response against
a protein called human chorionic gonadotropin-beta (hCG-β). hCG-β is made by several types
of cancers, including bladder cancer, and has been shown to be associated with shorter times
to development of metastases and reduced survival in bladder cancer. In this study, it is
hoped that administering the CDX-1307 vaccine will cause the body's immune system to attack
bladder cancer cells in order to kill them or otherwise keep them from spreading or coming
back.

Standard treatment for early stage, muscle invasive bladder cancer includes the
administration of chemotherapy to shrink the tumor followed by surgical removal of the
bladder (cystectomy).

This study will compare the effect of adding CDX-1307 administration to this standard
treatment. CDX-1307 will be given with 3 different immune stimulants to try to increase the
immune response against the tumor cells; collectively, this is called the "CDX-1307 vaccine
regimen."

Only patients whose tumors make the hCG-β protein will be included in this study. Eligible
patients will receive "standard of care" chemotherapy with the CDX-1307 vaccine regimen
before surgery, and then CDX-1307 vaccine regimen alone (without chemotherapy) after
surgery.

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible to
be in the study:

1. 18 years of age or older.

2. Newly diagnosed muscle-invasive transitional cell (urothelial) bladder cancer where
neoadjuvant chemotherapy and radical cystectomy with curative intent are indicated
(i.e., American Joint Committee on Cancer (AJCC) stage T2-4a, Nany, M0). Patients
must be entered into the study within eight weeks of their most recent diagnostic
procedure, which is usually a diagnostic biopsy or transurethral resection of bladder
tumor (TURBT) procedure.

3. Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial
tumors with mixed histology (but with <50% variant) are eligible.

4. Tumor tissue (obtained during a prior procedure) confirmed to express hCG-β by a
central laboratory.

5. Candidate for therapy with neoadjuvant chemotherapy.

Exclusion Criteria:

Among other criteria, patients who meet any of the following conditions are NOT eligible
to be in the study:

1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior
immunotherapy or intravesical (administered within the bladder) chemotherapy for
superficial disease is acceptable.

2. History of anaphylactic reaction following exposure to humanized or human therapeutic
monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products,
clinically meaningful allergic reactions to imiquimod, resiquimod, or any known
hypersensitivity or prior reaction to any of the formulation excipients in the study
drugs.

3. Concurrent chronic treatment with immunosuppressive or immunomodulatory agents,
including any systemic steroid (exception: inhaled or topically applied steroids, and
acute and chronic standard dose NSAIDs, are permitted).

4. Known infection with HIV, HBV or HCV.

5. Any underlying medical condition that, in the Investigator's opinion, will make the
administration of study vaccine hazardous to the patient, would obscure the
interpretation of adverse events, or would contraindicate receipt of neoadjuvant
chemotherapy or surgical resection.