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A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers
Trial ID: NCT01460134
This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.
A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients With Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors
Professor of Medicine (Oncology)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Professor of Medicine (Oncology) and, by courtesy, of Urology
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Jonathan S. Berek, MD, MMSc
Laurie Kraus Lacob Professor
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Among other criteria, patients must meet the following conditions to be eligible for the
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
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
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.
Among other criteria, patients who meet the following conditions are NOT eligible for the
1. Known prior primary or metastatic brain or meningeal tumors.
2. Receiving treatment with immunosuppressive agents, including any systemic steroids.
3. Active infection requiring systemic therapy, known HIV infection, or positive test for
hepatitis B surface antigen or hepatitis C.
4. Is being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter
5. Women who are pregnant or lactating.
6. Prior allogeneic bone marrow transplant.
7. Autologous bone marrow transplant within 100 days of first dosing.
8. Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on
9. Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks
prior to first dosing.
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