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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03063762
Recruitment Status : Active, not recruiting
First Posted : February 24, 2017
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Atezolizumab Drug: Bevacizumab Drug: RO6874281 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Randomized, Dose-Escalation, Phase 1b Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 in Combination With Atezolizumab ± Bevacizumab in Patients With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : September 16, 2020
Estimated Study Completion Date : December 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escalation Part (Arm A): Atezolizumab, RO6874281
Participants will receive RO6874281 in combination with atezolizumab once a week for 4 weeks followed by once every 2 weeks afterwards until disease progression, unacceptable toxicities, or withdrawal of consent, or as long as the participant experiences clinical benefit, or if the participant has complete response (CR), treatment may be discontinued and reintroduced if progressive disease (PD), for a maximum duration of 24 months.
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

Other Name: Tecentriq®

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


Experimental: Escalation Part (Arm B): Atezolizumab, Bevacizumab, RO6874281
Participants will receive RO6874281 in combination with atezolizumab and bevacizumab until disease progression, unacceptable toxicities, or withdrawal of consent, or as long as the participant experiences clinical benefit, or if the participant has CR, treatment may be discontinued and reintroduced if PD, for a maximum duration of 24 months.
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

Other Name: Tecentriq®

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.

Other Name: Avastin®

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


Experimental: Extension Part (Arm A): Atezolizumab, RO6874281

Based on the maximum tolerated dose or recommended dose as determined in the dose-escalation part, participants will receive RO6874281 in combination with atezolizumab once a week for 4 weeks followed by once every 2 weeks afterwards until disease progression, unacceptable toxicities, or withdrawal of consent, or as long as the participant experiences clinical benefit, or if the participant has CR, treatment may be discontinued and reintroduced if PD, for a maximum duration of 24 months.

Note: no new participants are being enrolled in the arm at this time.

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

Other Name: Tecentriq®

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


Experimental: Extension Part (Arm B): Atezolizumab, Bevacizumab, RO6874281

Based on the maximum tolerated dose or recommended dose as determined in the dose-escalation part, participants will receive RO6874281 in combination with atezolizumab and bevacizumab once a week for 4 weeks followed by once every 2 weeks afterwards until disease progression, unacceptable toxicities, or withdrawal of consent, or as long as the participant experiences clinical benefit, or if the participant has CR, treatment may be discontinued and reintroduced if PD, for a maximum duration of 24 months.

Note: no new participants are being enrolled in the arm at this time.

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

Other Name: Tecentriq®

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.

Other Name: Avastin®

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


Experimental: Extension Part (Arm C): Atezolizumab, RO6874281

Based on the maximum tolerated dose or recommended dose as determined in the dose-escalation part, participants will receive RO6874281 in combination with atezolizumab once every 3 weeks until disease progression, unacceptable toxicities, or withdrawal of consent, or as long as the participant experiences clinical benefit, or if the participant has CR, treatment may be discontinued and reintroduced if PD, for a maximum duration of 24 months.

Note: no new participants are being enrolled in the arm at this time.

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

Other Name: Tecentriq®

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


Experimental: Extension Part (Arm D): Atezolizumab, Bevacizumab, RO6874281

Based on the maximum tolerated dose or recommended dose as determined in the dose-escalation part, participants will receive RO6874281 in combination with atezolizumab and bevacizumab once every 3 weeks until disease progression, unacceptable toxicities, or withdrawal of consent, or as long as the participant experiences clinical benefit, or if the participant has CR, treatment may be discontinued and reintroduced if PD, for a maximum duration of 24 months.

Note: Arm D is closed for future enrollment

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

Other Name: Tecentriq®

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.

Other Name: Avastin®

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





Primary Outcome Measures :
  1. Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Arm A: It ends one week after the second administration of RO6874281 + atezolizumab Arm B: one week after the first administration of RO6874281 + atezolizumab + bevacizumab ]
  2. Maximum Tolerated Dose (MTD) of RO6874281 [ Time Frame: Arm A: It ends one week after the second administration of RO6874281 + atezolizumab Arm B: one week after the first administration of RO6874281 + atezolizumab + bevacizumab ]
  3. Recommended Dose of RO6874281 [ Time Frame: Arm A: It ends one week after the second administration of RO6874281 + atezolizumab Arm B: one week after the first administration of RO6874281 + atezolizumab + bevacizumab ]
  4. Percentage of Participants with Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Screening until disease progression or study treatment discontinuation (assessed at every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 24 months) ]

Secondary Outcome Measures :
  1. Serum RO6874281 Concentration [ Time Frame: Pre-infusion on Cycle 1 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 1 hour (hr) post start of infusion, end of infusion (EOI), 2, 6 hr post EOI on Cycle 1 Day 1; Cycle 1 Days 2, 3; Pre-infusion, 1 hr post start of infusion, EOI, 2, 6 hr post EOI on Cycle 1 Day 8; Cycle 1 Days 9, 10; Pre-infusion, EOI on Cycle 2 Day 1; Pre-infusion on Cycle 3 Day 1; Cycle 3 Day 2; Pre-infusion on Cycle 4 Day 1; Pre-infusion on Cycle 5 Day 1; Cycle 5 Day 2; Pre-infusion on Day 1; Day 2 in Cycle 9 and then every 4 cycles for the first year followed by every 6 cycles; treatment discontinuation; 28 days after last dose; 3 months after last dose (up to 60 months) (Pre-infusion = 0 hr for Day 1 Cycles 1, 2; -4 hr for other timepoints) (infusion length = 2 hr) (1 cycle = 15 days)

  2. Area Under the Serum Concentration-Time Curve (AUC) for RO6874281 [ Time Frame: Pre-infusion on Cycle 1 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 1 hr post start of infusion, EOI, 2, 6 hr post EOI on Cycle 1 Day 1; Cycle 1 Days 2, 3; Pre-infusion, 1 hr post start of infusion, EOI, 2, 6 hr post EOI on Cycle 1 Day 8; Cycle 1 Days 9, 10; Pre-infusion, EOI on Cycle 2 Day 1; Pre-infusion on Cycle 3 Day 1; Cycle 3 Day 2; Pre-infusion on Cycle 4 Day 1; Pre-infusion on Cycle 5 Day 1; Cycle 5 Day 2; Pre-infusion on Day 1; Day 2 in Cycle 9 and then every 4 cycles for the first year followed by every 6 cycles; treatment discontinuation; 28 days after last dose; 3 months after last dose (up to 60 months) (Pre-infusion = 0 hr for Day 1 Cycles 1, 2; -4 hr for other timepoints) (infusion length = 2 hr) (1 cycle = 15 days)

  3. Maximum Observed Serum Concentration (Cmax) of RO6874281 [ Time Frame: Pre-infusion on Cycle 1 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 1 hr post start of infusion, EOI, 2, 6 hr post EOI on Cycle 1 Day 1; Cycle 1 Days 2, 3; Pre-infusion, 1 hr post start of infusion, EOI, 2, 6 hr post EOI on Cycle 1 Day 8; Cycle 1 Days 9, 10; Pre-infusion, EOI on Cycle 2 Day 1; Pre-infusion on Cycle 3 Day 1; Cycle 3 Day 2; Pre-infusion on Cycle 4 Day 1; Pre-infusion on Cycle 5 Day 1; Cycle 5 Day 2; Pre-infusion on Day 1; Day 2 in Cycle 9 and then every 4 cycles for the first year followed by every 6 cycles; treatment discontinuation; 28 days after last dose; 3 months after last dose (up to 60 months) (Pre-infusion = 0 hr for Day 1 Cycles 1, 2; -4 hr for other timepoints) (infusion length = 2 hr) (1 cycle = 15 days)

  4. Serum Atezolizumab Concentration [ Time Frame: Pre-infusion on Cycle 1 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 0.5 hr post EOI on Cycle 1 Day 1; Pre-infusion on Cycle 1 Day 8; Pre-infusion on Day 1 Cycles 2, 3, 4, 5, and 9 onwards; treatment discontinuation; 28, 120 days after last dose (up to 60 months) (Pre-infusion = -4 hr) (infusion length = 1 hr) (1 cycle = 15 days)

  5. AUC of Atezolizumab [ Time Frame: Pre-infusion on Cycle 1 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 0.5 hr post EOI on Cycle 1 Day 1; Pre-infusion on Cycle 1 Day 8; Pre-infusion on Day 1 Cycles 2, 3, 4, 5, and 9 onwards; treatment discontinuation; 28, 120 days after last dose (up to 60 months) (Pre-infusion = -4 hr) (infusion length = 1 hr) (1 cycle = 15 days)

  6. Cmax of Atezolizumab [ Time Frame: Pre-infusion on Cycle 1 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 0.5 hr post EOI on Cycle 1 Day 1; Pre-infusion on Cycle 1 Day 8; Pre-infusion on Day 1 Cycles 2, 3, 4, 5, and 9 onwards; treatment discontinuation; 28, 120 days after last dose (up to 60 months) (Pre-infusion = -4 hr) (infusion length = 1 hr) (1 cycle = 15 days)

  7. Serum Bevacizumab Concentration [ Time Frame: Pre-infusion on Cycle 2 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 0.5 hr post EOI on Cycle 2 Day 1; Pre-infusion on Cycle 2 Day 8; Pre-infusion on Day 1 Cycles 3, 4, 5, and 9 onwards; treatment discontinuation; 28 days after last dose (up to 60 months) (Pre-infusion = 0 hr for Day 1 Cycles 2, 3; -4 hr for other timepoints) (infusion length = 1.5 hr) (1 cycle = 15 days)

  8. AUC of Bevacizumab [ Time Frame: Pre-infusion on Cycle 2 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 0.5 hr post EOI on Cycle 2 Day 1; Pre-infusion on Cycle 2 Day 8; Pre-infusion on Day 1 Cycles 3, 4, 5, and 9 onwards; treatment discontinuation; 28 days after last dose (up to 60 months) (Pre-infusion = 0 hr for Day 1 Cycles 2, 3; -4 hr for other timepoints) (infusion length = 1.5 hr) (1 cycle = 15 days)

  9. Cmax of Bevacizumab [ Time Frame: Pre-infusion on Cycle 2 Day 1 up to 60 months (detailed timeframe is provided in outcome measure description) ]
    Pre-infusion, 0.5 hr post EOI on Cycle 2 Day 1; Pre-infusion on Cycle 2 Day 8; Pre-infusion on Day 1 Cycles 3, 4, 5, and 9 onwards; treatment discontinuation; 28 days after last dose (up to 60 months) (Pre-infusion = 0 hr for Day 1 Cycles 2, 3; -4 hr for other timepoints) (infusion length = 1.5 hr) (1 cycle = 15 days)

  10. Percentage of Participants with Anti-Drug Antibodies (ADA) to RO6874281 [ Time Frame: Baseline until 3 months post last dose of study treatment (detailed timeframe is provided in outcome measure description) ]
    Baseline until 3 months post last dose of study treatment (assessed at pre-infusion on Days 1, 8 of Cycle 1; Pre-infusion on Day 1 of Cycles 2, 3, 4, 5, 9 and then every 4 cycles for the first year followed by every 6 cycles; treatment discontinuation; 28 days after last dose; 3 months after last dose [up to 60 months] [Pre-infusion = 0 hr for Day 1 Cycles 1, 2; -4 hr for other timepoints] [infusion length = 2 hr] [1 cycle = 15 days])

  11. Absolute Lymphocytes Count in Peripheral Blood [ Time Frame: Screening until 120 days post last dose of study treatment (up to 60 months) ]
  12. Density of Lymphocytes in Tumor Samples [ Time Frame: Archival biopsy: Baseline; Fresh biopsies: Baseline, Day 8 of Cycle 4; Optional biopsies: Any time during the study conduct (1 cycle = 15 days) (up to 60 months) ]
  13. Percentage of Participants with Programmed Death-Ligand 1 (PD-L1) Status in Tumor Samples [ Time Frame: Archival biopsy: Baseline; Fresh biopsies: Baseline, Day 8 of Cycle 4; Optional biopsies: Any time during the study conduct (1 cycle = 15 days) (up to 60 months) ]
  14. Percentage of Participants with CR as Determined by the Investigator Using RECIST v1.1 [ Time Frame: Screening until disease progression or study treatment discontinuation (assessed at every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 24 months) ]
  15. Percentage of Participants with Disease Control as Determined by the Investigator Using RECIST v1.1 [ Time Frame: Screening until disease progression or study treatment discontinuation (assessed at every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 24 months) ]
  16. Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 [ Time Frame: Screening until disease progression or study treatment discontinuation (assessed at every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 24 months) ]
  17. Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 [ Time Frame: From randomization until disease progression or study treatment discontinuation (assessed at every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 24 months) ]
  18. Overall Survival (OS) [ Time Frame: From randomization until death (up to 60 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 hepatitis B virus (HBV) or hepatitis C virus (HCV) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063762


Locations
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United States, Connecticut
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States, 06520
United States, Illinois
Northwestern Center for Clinical Research; Cancer Center
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Canada, Ontario
Princess Margaret Hospital, Medical Oncology & Haematology
Toronto, Ontario, Canada, M5G 2M9
Denmark
Herlev Hospital; Onkologisk afdeling
Herlev, Denmark, 2730
France
Centre Francois Baclesse; Oncologie
Caen, France, 14076
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon, France, 69008
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, Germany, 72076
Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU
Würzburg, Germany, 97080
Italy
Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia
Modena, Emilia-Romagna, Italy, 41100
Fondazione IRCCS Policlinico San Matteo, Oncologia
Pavia, Lombardia, Italy, 27100
Korea, Republic of
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 6351
Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, Spain, 08036
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
United Kingdom
Barts & London School of Med; Medical Oncology
London, United Kingdom, EC1A 7BE
The Christie
Manchester, United Kingdom, M20 4BX
Southampton General Hospital; Medical Oncology
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03063762     History of Changes
Other Study ID Numbers: BP39365
2016-003528-22 ( EudraCT Number )
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:
Renal Cell Carcinoma
RO6874281
Atezolizumab
Bevacizumab

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors