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A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02386111
Recruitment Status : Terminated (Portfolio re-prioritization)
First Posted : March 11, 2015
Last Update Posted : July 26, 2018
Information provided by (Responsible Party):
Celldex Therapeutics

Brief Summary:
This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and sunitinib. The study will enroll patients with metastatic clear cell renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Kidney Diseases Kidney Neoplasms Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Neoplasms Neoplasms by Histologic Type Clear-cell Metastatic Renal Cell Carcinoma Drug: Combination of varlilumab and sunitinib Phase 1

Detailed Description:

Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects.

Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) some of which play a role in tumor growth and progression of cancer.

This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with sunitinib.

Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 50 mg of sunitinib. The first phase of the study will test the safety profile of the combination and determine which dose of varlilumab will be studied in Phase ll* of the overall study.

*Note: This Study was terminated prior to initiation of Phase II.

All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase l/ll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Study Start Date : May 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : November 3, 2017

Arm Intervention/treatment
Experimental: Varlilumab and Sunitinib Drug: Combination of varlilumab and sunitinib

During the treatment phase of the study, eligible patients will receive varlilumab for up to 8 cycles. Treatment cycles are 6 weeks each with varlilumab administered once every 3 weeks and sunitinib administered daily for 4 weeks followed by a 2 week rest. There is no limit on the number of cycles of sunitinib. Patients may be discontinued from receiving study treatment (sunitinib or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.

Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg or 3 mg/kg.

The Study was terminated prior to initiation of Phase II.

All patients will receive sunitinib at a dose of 50 mg.

Primary Outcome Measures :
  1. Phase 1: Safety and tolerability of varlilumab and varlilumab in combination with sunitinib as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities. [ Time Frame: Safety follow-up is 100 days from last study drug dose. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
  2. Advanced metastatic disease
  3. Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
  4. For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count towards the total).
  5. Measurable (target) disease.
  6. Life expectancy ≥ 12 weeks.
  7. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose.
  8. Must have available tumor tissue and consent to biopsy while on study.

Exclusion Criteria:

  1. Prior therapy with an anti-CD27 antibody.
  2. Previous treatment with sunitinib.
  3. Use of any experimental immunotherapy.
  4. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
  5. Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
  6. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
  7. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
  8. Active, untreated central nervous system metastases.
  9. Active autoimmune disease or a documented history of autoimmune disease.
  10. Active diverticulitis.
  11. Significant cardiovascular disease including CHF or poorly controlled hypertension.
  12. Impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386111

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
UCSF Helen Diller Comprehensive Cancer Center
San Francisco, California, United States, 94158
United States, District of Columbia
George Washington University-Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Nebraska
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Celldex Therapeutics
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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT02386111    
Other Study ID Numbers: CDX1127-04
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: November 2017
Keywords provided by Celldex Therapeutics:
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms by Histologic Type
Urogenital Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action