Kidney Cancer Clinical Trial

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)

Summary

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.

View Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT03063762

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 23 Locations for this study

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Yale Cancer Center; Medical Oncology
New Haven Connecticut, 06520, United States
Northwestern Center for Clinical Research; Cancer Center
Chicago Illinois, 60611, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Herlev Hospital; Afdeling for Kræftbehandling
Herlev , 2730, Denmark
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon , 69008, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse , 31059, France
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen , 72076, Germany
Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU
Würzburg , 97078, Germany
Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia
Modena Emilia-Romagna, 41100, Italy
Fondazione IRCCS Policlinico San Matteo, Oncologia
Pavia Lombardia, 27100, Italy
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona , 08036, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia , 46010, Spain
Barts & London School of Med; Medical Oncology
London , EC1A , United Kingdom
The Christie
Manchester , M20 4, United Kingdom
Southampton General Hospital; Medical Oncology
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT03063762

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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