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)

PHASE1CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

March 20, 2017

Primary Completion Date

June 14, 2021

Study Completion Date

June 14, 2021

Conditions
Renal Cell Carcinoma
Interventions
DRUG

Atezolizumab

"Arms A and B Atezolizumab will be administered at a dose of 840 milligrams (mg) prior to RO6874281 administration as an intravenous (IV) infusion on Days 1, 15, 29, and once in 2 weeks from Day 29 onwards. Doses in the extension part will be based on the maximum tolerated dose determined in the escalation part.~Arms C and D Atezolizumab will be administered at a dose of 1200mg as it is a Q3W schedule"

DRUG

Bevacizumab

"Arms A and B Bevacizumab will be administered at a dose of 10 milligrams per kilogram (mg/kg) after the atezolizumab administration, and prior to RO6874281 administration as an IV infusion on Days 15, 29, and once in 2 weeks from Day 29 onwards.~In Arm D, Bevacizumab will be administered at a dose of 15mg/kg on Day 8 of Cycle 2 and on Day 8 of each consecutive cycle."

DRUG

RO6874281

"Arms A and B RO6874281 will be administered as an IV infusion on Days 1, 8, 15, 22, and 29, and once in 2 weeks from Day 29 onwards. Starting dose of RO6874281 will be 5 mg, and will be increased subsequently. Doses in the extension part will be based on the maximum tolerated dose determined in the escalation part.~In Arms C and D, RO will be administered on Q3W schedule at the dose defined in the dose escalation part"

Trial Locations (23)

2730

Herlev Hospital; Afdeling for Kræftbehandling, Herlev

21201

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore

27100

Fondazione IRCCS Policlinico San Matteo, Oncologia, Pavia

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28040

START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid

31008

Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona

31059

Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse

41100

Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia, Modena

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

60611

Northwestern Center for Clinical Research; Cancer Center, Chicago

69008

Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes, Lyon

72076

Universitätsklinikum Tübingen; Klinik für Urologie, Tübingen

97078

Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU, Würzburg

06520

Yale Cancer Center; Medical Oncology, New Haven

M5G 1Z5

Princess Margaret Cancer Center, Toronto

05505

Asan Medical Center, Seoul

135-710

Samsung Medical Center, Seoul

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

08036

Hospital Clínic i Provincial; Servicio de Oncología, Barcelona

EC1A 7BE

Barts & London School of Med; Medical Oncology, London

M20 4BX

The Christie, Manchester

SO16 6YD

Southampton General Hospital; Medical Oncology, Southampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03063762 - 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) | Biotech Hunter | Biotech Hunter