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)
Completed · Phase 1
Conditions studied: Renal Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT03063762
- Run by
- Hoffmann-La Roche
- People needed
- 69
- Starts
- 2017-03-20
- Expected to finish
- 2021-06-14
- Last updated by the study team
- 2023-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
- Samsung Medical Center — Seoul, South Korea
- Clinica Universitaria de Navarra; Servicio de Oncologia — Pamplona, Navarre, Spain
- Hospital del Mar; Servicio de Oncologia — Barcelona, Spain
- Hospital Univ Vall d'Hebron; Servicio de Oncologia — Barcelona, Spain
- Hospital Clínic i Provincial; Servicio de Oncología — Barcelona, Spain
- Hospital Ramon y Cajal; Servicio de Oncologia — Madrid, Spain
- START Madrid-FJD, Hospital Fundacion Jimenez Diaz — Madrid, Spain
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia — Valencia, Spain
- Barts & London School of Med; Medical Oncology — London, United Kingdom
- The Christie — Manchester, United Kingdom
- Southampton General Hospital; Medical Oncology — Southampton, United Kingdom
Full record on ClinicalTrials.gov
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