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Trial record 1 of 1 for:    NCT04338269
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A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment (CONTACT-03)

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ClinicalTrials.gov Identifier: NCT04338269
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : October 6, 2021
Sponsor:
Collaborators:
Exelixis
Chugai
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 6, 2020
First Posted Date  ICMJE April 8, 2020
Last Update Posted Date October 6, 2021
Actual Study Start Date  ICMJE July 28, 2020
Estimated Primary Completion Date December 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
  • Progression-Free Survival (PFS), as assessed by Independent Review Facility (IRF) [ Time Frame: Randomization up to approximately 27 months ]
    Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, as assessed by Independent Review Facility (IRF-PFS) or death from any cause, whichever occurs first.
  • Overall survival (OS) [ Time Frame: Randomization up to approximately 52 months ]
    Overall survival (OS), defined as the time from randomization to death from any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • PFS Assessed by the Investigators (INV-PFS) [ Time Frame: Randomization up to approximately 27 months ]
    PFS assessed by the investigators (INV-PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first).
  • Investigator Assessed Objective Response Rate (INV-ORR) [ Time Frame: Randomization up to approximately 27 months ]
    INV-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
  • IRF Assessed Objective Response Rate (IRF-ORR) [ Time Frame: Randomization up to approximately 27 months ]
    IRF-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
  • Investigator Assessed Duration of Objective Response (INV-DOR) [ Time Frame: Randomization up to approximately 27 months ]
    INV-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
  • IRF Assessed DOR (IRF-DOR) [ Time Frame: Randomization up to approximately 27 months ]
    IRF-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
  • Percentage of Participants With Adverse Events [ Time Frame: Randomization up to approximately 27 months ]
  • Atezolizumab Concentrations [ Time Frame: At pre-defined intervals from first administration of study drug up to approximately 27 months ]
  • Cabozantinib Concentrations [ Time Frame: At pre-defined intervals from first administration of study drug up to approximately 27 months ]
  • Prevalence of Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Baseline ]
  • Incidence of ADAs to Atezolizumab During the Study [ Time Frame: At pre-defined intervals from first administration of study drug up to approximately 27 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
  • PFS Assessed by the Investigators (INV-PFS) [ Time Frame: Randomization up to approximately 27 months ]
    PFS assessed by the investigators (INV-PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first).
  • Investigator Assessed Objective Response Rate (INV-ORR) [ Time Frame: Randomization up to approximately 27 months ]
    INV-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
  • IRF Assessed Objective Response Rate (IRF-ORR) [ Time Frame: Randomization up to approximately 27 months ]
    IRF-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
  • Investigator Assessed Duration of Objective Response (INV-DOR) [ Time Frame: Randomization up to approximately 27 months ]
    INV-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
  • IRF Assessed DOR (IRF-DOR) [ Time Frame: Randomization up to approximately 27 months ]
    IRF-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
  • Percentage of Participants With Adverse Events [ Time Frame: Randomization up to approximately 27 months ]
  • Atezolizumab Concentrations [ Time Frame: Pre-infusion and post infusion on Day 1 of Cycle 1; predose on Day 1 of Cycle 2; predose on Day 1 of Cycle 3 and Cycle 4, predose on Day 1 of Cycle 8, 12 and 16; at treatment discontinuation (up to approximately 27 months) ]
  • Cabozantinib Concentrations [ Time Frame: Predose on Day 1 of Cycle 2; predose on Day 1 of Cycle 3 and Cycle 4; at treatment discontinuation (up to approximately 27 months) ]
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Baseline ]
  • Number of ADAs to Atezolizumab [ Time Frame: Predose on Day 1 of Cycle 1; predose on Day 1 of Cycle 2; predose on Day 1 of Cycle 3 and Cycle 4; predose on Day 1 of Cycle 8, Cycle 12, and Cycle 16; at treatment discontinuation (up to approximately 27 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Official Title  ICMJE A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
Brief Summary This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE
  • Drug: Atezolizumab
    Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.
    Other Name: Tecentriq
  • Drug: Cabozantinib
    Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.
    Other Name: Cabometyx
Study Arms  ICMJE
  • Experimental: Atezo+Cabo
    Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Cabozantinib
  • Active Comparator: Cabozantinib
    Participants will receive cabozantinib every day.
    Intervention: Drug: Cabozantinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 11, 2024
Estimated Primary Completion Date December 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
  • Radiographic disease progression during or following treatment with ICI for locally advanced or metastatic RCC either in first- or second-line treatment. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.
  • Measurable disease per RECIST v1.1
  • Evaluable IMDC risk score
  • Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred.
  • KPS score of >=70
  • Recovery to baseline or Grade </= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation
  • Adequate hematologic and end-organ function
  • Negative HIV test at screening
  • Negative hepatitis B testing at screening
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
  • Patients received cabozantinib at any time prior to screening
  • Patients who received more than one ICI treatment in the locally advanced or metastatic setting
  • Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
  • Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting
  • Symptomatic, untreated, or actively progressing CNS metastases
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1
  • Active tuberculosis
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
  • Pharmacologically uncompensated, symptomatic hypothyroidism
  • Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment
  • Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
  • History of congenital QT syndrome
  • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: WO41994 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Denmark,   France,   Germany,   Greece,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04338269
Other Study ID Numbers  ICMJE WO41994
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE
  • Exelixis
  • Chugai
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date October 2021

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