Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
A Phase II Study of Bevacizumab Alone or in Combination With TRC105 for Advanced Renal Cell Cancer
9 other identifiers
interventional
59
3 countries
30
Brief Summary
This randomized phase II trial studies how well bevacizumab with or without anti-endoglin monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by targeting certain cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2012
Longer than P75 for phase_2
30 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
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2017
CompletedResults Posted
Study results publicly available
June 26, 2018
CompletedAugust 28, 2018
July 1, 2018
4.8 years
November 12, 2012
April 24, 2018
July 30, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free Survival at 24 Weeks
Progression-free survival 24 after starting treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The duration of time from start of treatment to time of progression or death, assessed at 24 weeks
Progression-free Survival at 12 Weeks
Progression-free survival 12 after starting treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The duration of time from start of treatment to time of progression or death, assessed at 12 weeks
Secondary Outcomes (2)
Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment
From time of treatment initiation until 30 days post treatment, assessed every 4 weeks.
Number of Participants With Overall Response
From time of treatment initiation until conclusion of treatment, assessed every 12 weeks.
Study Arms (2)
Arm I (bevacizumab)
ACTIVE COMPARATORPatients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Arm II (bevacizumab, anti-endoglin monoclonal antibody TRC105)
EXPERIMENTALPatients receive bevacizumab as in Arm I and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Correlative studies
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed renal cancer; all histologic subtypes will be eligible
- Patients must have metastatic disease which is measurable, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) to \>= 20 mm in the long axis by chest x-ray, \>= 10 mm in the long axis by spiral computed tomography (CT), magnetic resonance imaging (MRI), calipers, or clinical exam, or \>= 15 mm in the short axis for lymph nodes
- Patients must have received at least 1 prior systemic therapy for renal cancer but no more than 4 prior therapies; they must have documented intolerance to or progression despite at least 1 systemic therapy; therapy administered in the adjuvant setting counts toward the prior systemic therapy total; if adjuvant therapy is the patient's only prior therapy the disease must have recurred during treatment or within 3 months of discontinuation
- Allowable prior therapies include VEGF tyrosine kinase inhibitor (TKIs), mammalian target of rapamycin (mTOR) inhibitors, and cytokine therapy (example: interleukin-2 \[IL2\])
- At least 2 weeks must have elapsed from the last dose of the prior systemic therapy for biologics and 4 weeks for chemotherapy (6 weeks for nitrosoureas or mitomycin C); also note that at least 3 weeks should have elapsed since prior TKI administration
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Life expectancy of greater than 6 months
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin =\< institutional upper limits or normal (except for Gilbert's)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal (except subjects with liver metastases, who can have AST/ALT =\< 5 x ULN)
- Creatinine glomerular filtration rate (GFR) (calculated or measured) \> 50 mL/min
- Hemoglobin \>= 9 g/dL
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of TRC105 or bevacizumab administration
- +1 more criteria
You may not qualify if:
- Patients who have had systemic biologic therapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events related to their prior therapy
- Patients who have previously been treated with bevacizumab
- Patients who have previously been treated with TRC105
- Patients who are receiving any other investigational agents
- Known central nervous system (CNS) disease except for treated brain metastasis; treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (MRI or CT) (stable dose of anticonvulsants are allowed); treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC105 or bevacizumab
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unhealed wound, gastrointestinal fistula, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, cerebrovascular accident
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother wishes to participate in the study
- Patients with a history of bleeding diathesis or inherited coagulopathy are excluded; in addition, those with a history of deep vein thrombosis (DVT) or pulmonary embolus within 1 year and still requiring active anticoagulation will be excluded; those with a more remote history of DVT or pulmonary embolus may be eligible but the risk of recurrent thrombosis should be considered
- Patients with history of hereditary hemorrhagic telangiectasis (HHT-1 and HHT-2)
- Serious or non-healing wound, ulcer, or bone fracture OR history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
- Invasive procedures defined as follows:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 therapy
- Anticipation of need for major surgical procedures during the course of the study
- Core biopsy within 7 days prior to day 1 therapy
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
University of Colorado
Denver, Colorado, 80217-3364, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard
Fort Wayne, Indiana, 46804, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeff Longmate, Ph.D.
- Organization
- City of Hope
Study Officials
- PRINCIPAL INVESTIGATOR
Tanya Dorff
City of Hope Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 15, 2012
Study Start
November 1, 2012
Primary Completion
August 8, 2017
Study Completion
August 8, 2017
Last Updated
August 28, 2018
Results First Posted
June 26, 2018
Record last verified: 2018-07