A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers

Inclusion Criteria

• •Among other criteria, patients must meet the following conditions to be eligible for the study:
• •1. 18 years of age or older.
• •2. Body Weight ≤ 120 kg.
• •3. Histologic diagnosis of either a B-cell or T-cell hematologic malignancy known to express CD27 or one of the following solid tumors: metastatic melanoma, renal (clear) cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal adenocarcinoma or non-small cell lung cancer. For the solid tumor expansion cohorts, enrollment is limited to the following solid tumors: melanoma and renal cell carcinoma.
• •4. Tumor must be recurrent or treatment refractory with no remaining alternative, approved therapy options, with the following exception: melanoma patients enrolled in the expansion phase must have previously received ipilimumab and, for patients with the BRAF V600E mutation, vemurafenib, or have been offered such therapies and refused, and patients must have progressive disease subsequent to previous therapies.
• •5. Measurable or evaluable disease.
• •6. Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
• •7. If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
• •8. Have little or no side effects remaining from prior cancer therapies.
• •9. Provide written informed consent.