Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Unresectable advanced and/or metastatic RCC with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic therapy, including treatment in the adjuvant setting
During dose escalation only, an additional population with unresectable advanced and/or metastatic 2nd line RCC patients is allowed
At least one tumor lesion with location accessible to biopsy per clinical judgment of the treating physician
Consent to provide an archival tumor tissue sample (if available) and to undergo baseline and on treatment tumor biopsies for pharmacodynamic biomarker analysis
Measurable disease, as defined by RECIST v1.1. At least one lesion accessible for biopsy
Symptomatic or untreated central nervous system (CNS) metastases
Participants with asymptomatic CNS metastases with previous or concomitant brain deficiencies, as defined in the protocol
Participants with confirmed bilateral pleural effusion
Episode of significant cardiovascular/cerebrovascular acute disease within 6 months prior to Cycle 1 Day 1
Active or uncontrolled infections
Human immunodeficiency virus (HIV) or active Hepatitis A, B, C, D and E virus (HAV, HBV, HCV, HDV and HEV) infection.
Major surgery or significant traumatic injury \<28 days prior to Cycle 1 Day 1 (excluding fine needle biopsies) or anticipation of the need for major surgery during study treatment
Serious, non-healing wound; active ulcer; or untreated bone fracture
Proteinuria as demonstrated by a urine protein to creatinine ratio (UPCR) of \>=1.0 at screening
History of, active or suspicion of autoimmune disease
Concurrent use of high dose of systemic steroids. The use of inhaled, topical and ophthalmic steroids is allowed.
Clareo Health | Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)
