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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01727089
Registration number
NCT01727089
Ethics application status
Date submitted
12/11/2012
Date registered
15/11/2012
Date last updated
28/08/2018
Titles & IDs
Public title
Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
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Scientific title
A Phase II Study of Bevacizumab Alone or in Combination With TRC105 for Advanced Renal Cell Cancer
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Secondary ID [1]
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NCI-2012-02206
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Secondary ID [2]
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NCI-2012-02206
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clear Cell Renal Cell Carcinoma
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Recurrent Renal Cell Carcinoma
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Stage IV Renal Cell Cancer
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Type 1 Papillary Renal Cell Carcinoma
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Type 2 Papillary Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Anti-Endoglin Chimeric Monoclonal Antibody TRC105
Other interventions - Bevacizumab
Other interventions - Laboratory Biomarker Analysis
Other interventions - Pharmacological Study
Active Comparator: Arm I (bevacizumab) - Patients 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.
Experimental: Arm II (bevacizumab, anti-endoglin monoclonal antibody TRC105) - Patients 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.
Other interventions: Anti-Endoglin Chimeric Monoclonal Antibody TRC105
Given IV
Other interventions: Bevacizumab
Given IV
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Other interventions: Pharmacological Study
Correlative studies
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival at 24 Weeks
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Assessment method [1]
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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.
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Timepoint [1]
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The duration of time from start of treatment to time of progression or death, assessed at 24 weeks
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Primary outcome [2]
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Progression-free Survival at 12 Weeks
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Assessment method [2]
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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.
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Timepoint [2]
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The duration of time from start of treatment to time of progression or death, assessed at 12 weeks
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Secondary outcome [1]
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Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment
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Assessment method [1]
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The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be utilized for AE reporting.
Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related adverse event.
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Timepoint [1]
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From time of treatment initiation until 30 days post treatment, assessed every 4 weeks.
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Secondary outcome [2]
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Number of Participants With Overall Response
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Assessment method [2]
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Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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Timepoint [2]
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From time of treatment initiation until conclusion of treatment, assessed every 12 weeks.
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Eligibility
Key inclusion criteria
- 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
- Ability to understand and the willingness to sign a written informed consent document
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
- Patients on full-dose anticoagulation will be excluded; antiplatelet therapy will not
be exclusionary
- 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
- Patients with clinically significant cardiovascular disease are excluded:
- Inadequately controlled hypertension (HTN) (systolic blood pressure [SBP] > 160
mmHg and/or diastolic blood pressure [DBP] > 90 mmHg despite antihypertensive
medication)
- History of cerebrovascular accident (CVA) within 6 months
- Myocardial infarction or unstable angina within 6 months
- New York Heart Association grade II or greater congestive heart failure
- Serious and inadequately controlled cardiac arrhythmia
- Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection)
- Clinically significant peripheral vascular disease
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human antibodies
- Patients with psychiatric illness/social situations that would limit compliance with
study requirements will be excluded
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/08/2017
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Sample size
Target
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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Colorado
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Florida
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Illinois
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Indiana
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Iowa
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Maryland
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Michigan
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Minnesota
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Missouri
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New Jersey
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Cancer Institute (NCI)
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01727089
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tanya Dorff
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Address
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City of Hope Comprehensive Cancer Center
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01727089
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