Metastatic Renal Cell Carcinoma MedDRA version: 21.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CABOMETYX®
Product Name: Cabozantinib
Product Code: XL184
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CABOZANTINIB
CAS Number: 1140909-48-3
Current Sponsor code: XL184
Co
Sponsors
Exelixis, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component. - Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria. - Measurable disease per RECIST 1.1 as determined by the Investigator. - Karnofsky Performance Status (KPS) = 70%. - Adequate organ and marrow function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 418 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 258
Exclusion criteria
Exclusion criteria: - Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents. - Uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesion invading major pulmonary blood vessels. -Other clinically significant disorders such as: i. Autoimmune disease that has been symptomatic or required treatment within the past two years from the date of randomization ii. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. iii. Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection. --Major surgery (eg, nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from majo or minor surgery before randomization. - Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in previously untreated subjects with intermediate- and poor-risk advanced or metastatic RCC. ;Secondary Objective: Not applicable;Primary end point(s): Duration of PFS (Progression-Free Survival), per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC) ;Timepoint(s) of evaluation of this end point: The first tumor assessment after randomization should be performed at W10D1 (± 7 days). Subsequent tumor assessments should be performed every 8 weeks (± 7 days) from randomization through Week 50. Upon completion of 50 weeks on study, these assessments will be performed every 12 weeks (± 7 days). Additional imaging of potential disease sites should be performed whenever radiographic PD is suspected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of OS (overall survival);Timepoint(s) of evaluation of this end point: Overall survival (OS) will continue to be assessed every 12 weeks (± 14 days) after the second post-treatment follow-up visit (FU-2), which occurs 100 (±14) days after discontinuation of study treatment. Subjects will be followed until death or Sponsor decision to no longer collect these data | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactExelixis Medical Affairs
Exelixis, Inc.
Outcome results
None listed