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A Phase 2 Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma (IMmotion150)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01984242
First received: November 7, 2013
Last updated: May 22, 2017
Last verified: May 2017
  Purpose
This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, previously untreated locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.

Condition Intervention Phase
Renal Cell Carcinoma Drug: Atezolizumab Drug: Bevacizumab Drug: Sunitinib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Study of Atezolizumab (Anti PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1) via Central Independent Review Committee (IRC) Assessment in Intent-to-Treat (ITT) Population [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Progression-Free Survival per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1) via Central IRC Assessment in Participants who Have Detectable PD-L1 Expression [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]

Secondary Outcome Measures:
  • Progression-Free Survival per RECIST v.1.1 in Participants who Have Tumors With Higher Than Median Expression of an Immune Gene Signature [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Progression-Free Survival per RECIST v.1.1 in Participants who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Progression-Free Survival Using Investigator Assessment [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Percentage of Participants With Overall Response (Complete + Partial Response [CR+PR]) per RECIST v1.1 Using Investigator Assessment [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Percentage of Participants With Overall Response (CR+PR) per RECIST v1.1 via an Independent Central Radiologic Review [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Percentage of Participants With Overall Response per Modified RECIST Using Investigator Assessment [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Progression-Free Survival per Modified RECIST Using Investigator Assessment [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Duration of Response per RECIST v1.1 Criteria [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Duration of Response per Modified RECIST Criteria [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 2.5 years) ]
  • Overall Survival [ Time Frame: From randomization up to death or study completion (Up to approximately 2.5 years) ]
  • Percentage of Crossover Treatment Phase Participants With a Best Overall Response of CR or PR [ Time Frame: From Day 1 of crossover Cycle 1 (cycle length=6 weeks) until disease progression or death from any cause (up to approximately 1.5 years) ]
  • Duration of Response in Crossover Treatment Phase Participants [ Time Frame: From Day 1 of crossover Cycle 1 (cycle length=6 weeks) until disease progression or death from any cause (up to approximately 1.5 years) ]
  • Progression-Free Survival in Crossover Treatment Phase Participants [ Time Frame: From Day 1 of crossover Cycle 1 (cycle length=6 weeks) until disease progression or death from any cause (up to approximately 1.5 years) ]
  • Percentage of Participants With Adverse Events [ Time Frame: From randomization until 30 days after last dose of study treatment (up to approximately 5 years) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab [ Time Frame: Pre-infusion (0 hour) (infusion duration = 60 minutes) on Day 1 of Cycles 1, 2, 4 and 8, thereafter every 8 cycles (each cycle = 6 weeks) until end of treatment visit (up to approximately 2.5 years) ]
  • Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: 30 min post-infusion (infusion duration = 60 minutes) on Cycle 1 (cycle length = 6 weeks), Day 1 ]
  • Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Pre-infusion (0 hour) on Day 1 of Cycles 1, 2, and 4; Day 22 of Cycles 1, 2, and 4 (each cycle = 6 weeks); and at study termination (up to approximately 2.5 years) ]
  • Cmax of Bevacizumab [ Time Frame: 30 min post-infusion (infusion duration = 90 minutes) on Day 1 of Cycles 1 and 2 (each cycle = 6 weeks) ]
  • Cmin of Bevacizumab [ Time Frame: Pre-infusion (0 hour) (infusion duration = 60 minutes) on Day 1 of Cycles 1 and 2 (each cycle = 6 weeks), and at study termination (up to approximately 2.5 years) ]
  • M.D. Anderson Symptom Inventory (MDASI) Score [ Time Frame: From randomization up to end of treatment (up to approximately 2.5 years) ]
  • Brief Fatigue Inventory (BFI) Score [ Time Frame: From randomization up to end of treatment (up to approximately 2.5 years) ]
  • Euro Quality of Life 5 Dimension Questionnaire (EQ-5D) Score [ Time Frame: From randomization up to end of treatment (up to approximately 2.5 years) ]

Enrollment: 305
Actual Study Start Date: January 31, 2014
Estimated Study Completion Date: August 31, 2019
Primary Completion Date: October 17, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Atezolizumab + Bevacizumab
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Drug: Atezolizumab
1200 mg IV q3w
Other Name: Tecentriq, MPDL3280A, RO5541267
Drug: Bevacizumab
15 mg/kg IV q3w
Other Name: Avastin
Experimental: B: Atezolizumab
Atezolizumab 1200 mg IV infusions q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants may crossover to receive atezolizumab + bevacizumab combination until disease progression, unacceptable toxicity, withdrawal from study, or study completion or termination.
Drug: Atezolizumab
1200 mg IV q3w
Other Name: Tecentriq, MPDL3280A, RO5541267
Active Comparator: C: Sunitinib
Sunitinib 50 mg orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) may crossover to receive atezolizumab + bevacizumab combination until disease progression, unacceptable toxicity, withdrawal from study, or study completion or termination.
Drug: Sunitinib
50 mg orally once daily for 4 weeks, followed by 2 weeks of rest
Other Name: Sutent

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
  • Measurable disease, as defined by RECIST v1.1
  • Karnofsky performance score greater than or equal to (>/=) 70
  • Adequate hematologic and end-organ function as defined by protocol
  • Women of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective methods of contraception as defined by protocol

Exclusion Criteria:

Disease-Specific Exclusions:

  • Radiotherapy for renal cell carcinoma within 14 days prior to Cycle 1, Day 1 with the exception of: Single-fraction radiotherapy given for the indication of pain control
  • Known active malignancies or metastasis of the brain or spinal cord or leptomeningeal disease, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled hypercalcemia or symptomatic hypercalcemia
  • Malignancies other than renal cell carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome

General Medical Exclusions:

  • Life expectancy of less than (<) 12 weeks
  • Pregnant and lactating women
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Participants with active or chronic hepatitis B, active hepatitis C, Human Immunodeficiency Virus (HIV) positive test, significant cardiovascular disease
  • Prior allogeneic stem cell or solid organ transplant

Exclusion Criteria Related to Medications:

  • Prior treatment with Cluster of Differentiation 137 (CD137) agonists, anti-Cytotoxic T-Lymphocyte Antigen-4 (CTLA-4), anti-PD-1, or anti PD-L1 therapeutic antibody or pathway-targeting agents
  • Treatment with systemic immunostimulatory agents for any reason within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1

Bevacizumab- and Sunitinib-Specific Exclusions:

  • Inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association Class II or greater congestive heart failure
  • History of myocardial infarction or unstable angina, stroke or transient ischemic attack within 3 months prior to Cycle 1, Day 1
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984242

  Show 57 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01984242     History of Changes
Other Study ID Numbers: WO29074
2013-003167-58 ( EudraCT Number )
Study First Received: November 7, 2013
Last Updated: May 22, 2017

Additional relevant MeSH terms:
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
Sunitinib
Antibodies
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 17, 2017