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Study identifier: NCT03063762 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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)

Condition: Renal Cell Carcinoma  ·  Sponsor: Hoffmann-La Roche

PhasePhase 1
Planned participants69
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where23 locations · 9 countries

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.

About this study

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.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Full eligibility criteria (exactly as the study team wrote them)

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.

Locations (23)

Yale Cancer Center; Medical OncologyNew Haven, Connecticut, United States
Northwestern Center for Clinical Research; Cancer CenterChicago, Illinois, United States
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, Maryland, United States
Princess Margaret Cancer CenterToronto, Ontario, Canada
Herlev Hospital; Afdeling for KræftbehandlingHerlev, Denmark
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-AlpesLyon, France
Institut Claudius Regaud; Departement Oncologie MedicaleToulouse, France
Universitätsklinikum Tübingen; Klinik für UrologieTübingen, Germany
Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTUWürzburg, Germany
Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed EmatologiaModena, Emilia-Romagna, Italy
Fondazione IRCCS Policlinico San Matteo, OncologiaPavia, Lombardy, Italy
Asan Medical CenterSeoul, South Korea

+ 11 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

New HavenChicagoBaltimoreToronto

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