Condition: Renal Cell Carcinoma · Sponsor: Hoffmann-La Roche
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Yale Cancer Center; Medical Oncology | New Haven, Connecticut, United States | — |
| Northwestern Center for Clinical Research; Cancer Center | Chicago, Illinois, United States | — |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore, Maryland, United States | — |
| Princess Margaret Cancer Center | Toronto, Ontario, Canada | — |
| Herlev Hospital; Afdeling for Kræftbehandling | Herlev, Denmark | — |
| Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes | Lyon, France | — |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse, France | — |
| Universitätsklinikum Tübingen; Klinik für Urologie | Tübingen, Germany | — |
| Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU | Würzburg, Germany | — |
| Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia | Modena, Emilia-Romagna, Italy | — |
| Fondazione IRCCS Policlinico San Matteo, Oncologia | Pavia, Lombardy, Italy | — |
| Asan Medical Center | Seoul, South Korea | — |
+ 11 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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