This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
November 7, 2013
May 22, 2017
January 31, 2014
October 17, 2016   (Final data collection date for primary outcome measure)
  • 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) ]
Progression-free survival per RECIST v.1.1 via central ICR assessment [ Time Frame: approximately 2.5 years ]
Complete list of historical versions of study NCT01984242 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Progression-free survival using investigator assessment per immune-related criteria [ Time Frame: approximately 2.5 years ]
  • Overall response rate (complete + partial response) [ Time Frame: approximately 2.5 years ]
  • Duration of response [ Time Frame: approximately 2.5 years ]
  • Overall Survival [ Time Frame: approximately 2.5 years ]
  • Overall response rate in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to MPDL3280A + Avastin treatment [ Time Frame: approximately 1.5 years ]
  • Duration of response in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to MPDL3280A + Avastin treatment [ Time Frame: approximately 1.5 years ]
  • Progression-free survival in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to MPDL3280A + Avastin treatment [ Time Frame: approximately 1.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ]
  • Pharmacokinetics of MPDL3280A alone and in combination with bevacizumab: Area under the concentration-time curve [ Time Frame: Cycle 1 ]
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Drug: Atezolizumab
    1200 mg IV q3w
    Other Name: Tecentriq, MPDL3280A, RO5541267
  • Drug: Bevacizumab
    15 mg/kg IV q3w
    Other Name: Avastin
  • Drug: Sunitinib
    50 mg orally once daily for 4 weeks, followed by 2 weeks of rest
    Other Name: Sutent
  • 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.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Bevacizumab
  • 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.
    Intervention: Drug: Atezolizumab
  • 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.
    Intervention: Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
305
August 31, 2019
October 17, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czechia,   France,   Germany,   Italy,   Poland,   Romania,   Spain,   United Kingdom,   United States
Czech Republic,   Ukraine
 
NCT01984242
WO29074
2013-003167-58 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP