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A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT05805501
Recruitment Status : Recruiting
First Posted : April 10, 2023
Last Update Posted : June 7, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 28, 2023
First Posted Date  ICMJE April 10, 2023
Last Update Posted Date June 7, 2024
Actual Study Start Date  ICMJE April 21, 2023
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2023)
Progression-Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2023)
  • Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to 35 treatment cycles; cycle length = 21 days) ]
  • Confirmed Objective Response Rate (ORR) [ Time Frame: Up to 35 treatment cycles (cycle length = 21 days) ]
  • Duration of Response (DoR) [ Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
Official Title  ICMJE A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
Brief Summary This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib, as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Tobemstomig
    Participants will receive IV tobemstomig Q3W.
    Other Name: RO7247669
  • Drug: Tiragolumab
    Participants will receive IV tiragolumab Q3W.
  • Drug: Pembrolizumab
    Participants will receive IV pembrolizumab Q3W.
    Other Name: Keytruda
  • Drug: Axitinib
    Participants will receive axitinib PO BID.
    Other Name: Inlyta
Study Arms  ICMJE
  • Experimental: Arm A (Tobemstomig + Axitinib)
    Participants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID).
    Interventions:
    • Drug: Tobemstomig
    • Drug: Axitinib
  • Experimental: Arm B (Tobemstomig + Tiragolumab + Axitinib)
    Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
    Interventions:
    • Drug: Tobemstomig
    • Drug: Tiragolumab
    • Drug: Axitinib
  • Active Comparator: Control Arm (Pembrolizumab + Axitinib)
    Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Axitinib
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: March 28, 2023)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2026
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • International Metastatic RCC Database Consortium (IMDC) risk intermediate (score of 1 or 2) or poor (score of 3-6)
  • Measurable disease with at least one measurable lesion
  • Histologically confirmed ccRCC with or without sarcomatoid features
  • Negative for HIV, hepatitis B, or hepatitis C virus (HCV)

Exclusion Criteria:

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of tiragolumab, 4 months after the final dose of tobemstomig (RO7249669) and pembrolizumab, or for 1 week after the final dose of axitinib, whichever occurs last
  • Inability to swallow a tablet or malabsorption syndrome
  • Prior treatment for localized and/or metastatic RCC with systemic RCC-directed therapy, including T-cell costimulating or immune checkpoint blockade therapies
  • Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer
  • 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
  • Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • History of leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Moderate to severe hepatic impairment (Child-Pugh B or C)
  • Uncontrolled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Significant cardiovascular/cerebrovascular disease within 3 months prior to randomization
  • History of clinically significant ventricular dysrhythmias or risk factors for ventricular dysrhythmias
  • History of congenital QT syndrome
  • Resting heart rate (HR) > 100 bpm (or clinically significant tachycardia)
  • Stroke (including transient ischemic attack), myocardial infarction, or other symptomatic ischemic event, or thromboembolic event (e.g., deep venous thrombosis [DVT], pulmonary embolism [PE]) within 3 months before randomization
  • 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
  • Tumors invading pulmonary blood vessels, cavitating pulmonary lesions or known endobronchial disease
  • Tumor invading the gastrointestinal (GI) tract, including abdominal or tracheoesophageal fistulas
  • Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  • Active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric outlet obstruction
  • Intra-abdominal abscess within 6 months before initiation of study treatment
  • Clinical signs or symptoms of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
  • Evidence of bleeding diathesis or significant coagulopathy
  • Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
  • Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, coagulopathy, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before initiation of study treatment
  • Active or history of autoimmune disease or immune deficiency
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • History of another primary malignancy other than RCC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%)
  • Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live, attenuated vaccine will be required during the study
  • Active tuberculosis (TB)
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Participants with active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
  • Known hypersensitivity to Chinese hamster *ovary cell products or to any component of tobemstomig, tiragolumab, pembrolizumab, or axitinib
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: BO43936 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   China,   France,   Germany,   Korea, Republic of,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05805501
Other Study ID Numbers  ICMJE BO43936
Has Data Monitoring Committee No
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.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical 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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-LaRoche
PRS Account Hoffmann-La Roche
Verification Date June 2024

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