Skip to main content
OpenTrials
Completed

NCT Number: NCT01460134

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

CD27 Expressing B-cell Malignancies for Example Hodgkin's Lymphoma Adenocarcinoma Adnexal Diseases Any T-cell Malignancy Bronchial Neoplasms Burkett's Lymphoma Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Chronic Disease Chronic Lymphocytic Leukemia Colorectal Adenocarcinoma, Non-small Cell Lung Cancer) Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hormone-refractory Prostate Adenocarcinoma, Ovarian Cancer Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Mantle Cell Lymphoma Marginal Zone B Cell Lymphoma) Margins of Excision Melanoma Morphological and Microscopic Findings Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Lymphoma of the Central Nervous System Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Solid Tumors (Metastatic Melanoma, Renal (Clear) Cell Carcinoma Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic Arizona - Cancer Clinical Research Unit, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients with B-cell and T-cell hematologic malignancies known to express CD27 and solid tumors that are more likely to be responsive to the immune system.

Eligible patients who enroll in the dose escalation portion of the study will be assigned to one of 5 dose levels of CDX-1127. This first phase of the study will test the safety profile of CDX-1127 and will assess which dose to test in future studies.

During the Expansion phase, cohorts of approximately 15 patients each will receive the study treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has an effect on their cancer. Expansion cohorts may be limited to one or more tumor types.

Patients enrolled in the study may receive study treatment for up to 5 cycles, until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons.

All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

CDX-1127

Drug

Patients will initially receive a single dose of CDX-1127, followed by a 28-day observation period and a Multi-Dose Phase (one "cycle" of 4 weekly doses of CDX-1127). All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional "cycles"). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression.

The dose of CDX-1127 given for the Dose Escalation phase will depend on the cohort each patient is assigned to, and will range between 0.1 and 10.0 mg/kg of CDX-1127.

Primary outcomes

  1. Characterize the adverse events associated with CDX-1127 administration

    Time frame: Safety follow up is 70 days from last dose.

    Analysis of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX-1127.

Secondary outcomes

  1. Levels of anti-CD27 antibodies in circulating blood.

    Time frame: Until end of treatment

  2. Levels of CDX-1127 in circulating blood.

    Time frame: Until end of treatment

  3. Activity Evaluations

    Time frame: Until disease progression

    Determine the anti-malignant cell activity of CDX-1127 based on change from baseline in tumor measurements every 12 weeks.

  4. Immune system effects (eg: lymphoid cell populations and serum cytokine levels)

    Time frame: Until end of treatment

Sponsors and collaborators

Lead sponsor

Celldex Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Oct 26, 2011
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.