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A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
A Phase l/ll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
1 other identifier
interventional
17
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2015
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2017
CompletedJuly 26, 2018
November 1, 2017
2.3 years
March 6, 2015
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Safety follow-up is 100 days from last study drug dose.
Study Arms (1)
Varlilumab and Sunitinib
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
- Advanced metastatic disease
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count towards the total).
- Measurable (target) disease.
- Life expectancy ≥ 12 weeks.
- 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.
- Must have available tumor tissue and consent to biopsy while on study.
You may not qualify if:
- Prior therapy with an anti-CD27 antibody.
- Previous treatment with sunitinib.
- Use of any experimental immunotherapy.
- Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
- 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.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
- 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.
- Active, untreated central nervous system metastases.
- Active autoimmune disease or a documented history of autoimmune disease.
- Active diverticulitis.
- Significant cardiovascular disease including CHF or poorly controlled hypertension.
- Impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UCSF Helen Diller Comprehensive Cancer Center
San Francisco, California, 94158, United States
George Washington University-Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2015
First Posted
March 11, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2017
Study Completion
November 3, 2017
Last Updated
July 26, 2018
Record last verified: 2017-11