Phase 2
Completed N=59
Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
Source: ClinicalTrials.gov NCT01727089 ↗Enrolled (actual)
59
Serious AEs
40.7%
Results posted
Jun 2018
Primary outcomePrimary: Progression-free Survival at 24 Weeks — 52; 27 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 24 Weeks |
52; 27 | — |
| PRIMARY Progression-free Survival at 12 Weeks |
66; 58 | — |
| SECONDARY Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment |
3; 3; 4; 8; 0; 1 | — |
| SECONDARY Number of Participants With Overall Response |
1; 1 | — |
Eligibility Criteria
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 = = 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin = 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
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
Data sourced from ClinicalTrials.gov (NCT01727089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.