Status:
COMPLETED
A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers
Lead Sponsor:
Celldex Therapeutics
Conditions:
CD27 Expressing B-cell Malignancies for Example Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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),...
Detailed Description
CDX-1127 is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and also on certain hematologic tumor cells and may act to promote anti-tumor effects. ...
Eligibility Criteria
Inclusion
- Among other criteria, patients must meet the following conditions to be eligible for the study:
- 18 years of age or older.
- Body Weight ≤ 120 kg.
- 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.
- 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.
- Measurable or evaluable disease.
- Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
- If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
- Have little or no side effects remaining from prior cancer therapies.
- Provide written informed consent.
Exclusion
- Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- Known prior primary or metastatic brain or meningeal tumors.
- Receiving treatment with immunosuppressive agents, including any systemic steroids.
- Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C.
- Is being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter patency.
- Women who are pregnant or lactating.
- Prior allogeneic bone marrow transplant.
- Autologous bone marrow transplant within 100 days of first dosing.
- Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on treatment type).
- Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks prior to first dosing.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01460134
Start Date
October 1 2011
End Date
October 16 2017
Last Update
January 31 2018
Active Locations (10)
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1
Mayo Clinic Arizona - Cancer Clinical Research Unit
Scottsdale, Arizona, United States, 85259
2
Stanford Cancer Center - Stanford University
Stanford, California, United States, 94305
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Icahn School of Medicine at Mount Sinai Hess Center for Science and Medicine
New York, New York, United States, 10029