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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)

NCT03063762

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Renal Cell Carcinoma

Interventions: Atezolizumab, Bevacizumab, RO6874281

Countries: United States, Canada, Denmark, France, Germany, Italy, South Korea, Spain

This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* 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
* Participants with unilateral pleural effusion are eligible if they fulfill both of the following: (a) New York Heart Association (NYHA) Class 1; (b) Global initiative for obstructive lung disease (GOLD) test level 1 (forced expiratory volume in 1 second \[FEV1\]/ forced vital capacity \[FVC\] less than \[\<\] 0.7 and FEV1 greater than or equal to \[\>=\] 80 percent \[%\] predicted after inhaled bronchodilator)

Adequate hematological function: neutrophil count of ≥1.5 ≥109 cells/L, platelet count of ≥100,000/≥L, Hb ≥9 g/dL (5.6 mmol/L), lymphocytes ≥0.8 ≥109 cells/L.

Exclusion Criteria:

* 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.

Locations (23)

New Haven, Connecticut, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Toronto, Ontario, Canada
Herlev, Denmark
Lyon, France
Toulouse, France
Tübingen, Germany
Würzburg, Germany
Modena, Emilia-Romagna, Italy
Pavia, Lombardy, Italy
Seoul, South Korea
Seoul, South Korea
Pamplona, Navarre, Spain
Barcelona, Spain
Barcelona, Spain
Barcelona, Spain
Madrid, Spain
Madrid, Spain
Valencia, Spain
London, United Kingdom
Manchester, United Kingdom
Southampton, United Kingdom