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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05805501
Registration number
NCT05805501
Ethics application status
Date submitted
28/03/2023
Date registered
10/04/2023
Date last updated
7/06/2024
Titles & IDs
Public title
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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Scientific title
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
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Secondary ID [1]
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BO43936
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tobemstomig
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Axitinib
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).
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.
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.
Treatment: Drugs: Tobemstomig
Participants will receive IV tobemstomig Q3W.
Treatment: Drugs: Tiragolumab
Participants will receive IV tiragolumab Q3W.
Treatment: Drugs: Pembrolizumab
Participants will receive IV pembrolizumab Q3W.
Treatment: Drugs: Axitinib
Participants will receive axitinib PO BID.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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Timepoint [1]
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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)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Timepoint [1]
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From randomization to death from any cause (up to 35 treatment cycles; cycle length = 21 days)
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Secondary outcome [2]
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Confirmed Objective Response Rate (ORR)
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Assessment method [2]
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Timepoint [2]
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Up to 35 treatment cycles (cycle length = 21 days)
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Secondary outcome [3]
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Duration of Response (DoR)
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Assessment method [3]
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Timepoint [3]
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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)
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2026
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Actual
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Sample size
Target
210
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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Sunshine Coast University Hospital; The Adem Crosby Centre - Birtinya
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Recruitment hospital [2]
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ICON Cancer Care Adelaide - Kurralta Park
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Recruitment postcode(s) [1]
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4575 - Birtinya
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Recruitment postcode(s) [2]
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5037 - Kurralta Park
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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State/province [4]
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District of Columbia
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Country [5]
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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United States of America
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Tennessee
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United States of America
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Texas
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Country [10]
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China
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Beijing City
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China
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Beijing
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China
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Nanjing City
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China
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Tianjin
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China
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Xi'an
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France
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Avignon
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France
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Besançon Cedex
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France
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Bordeaux
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France
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Caen
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France
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Lyon
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France
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Villejuif
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Germany
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Dresden
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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München
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Germany
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Nürtingen
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Germany
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Tübingen
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Germany
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Ulm
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Seoul
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Poland
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Brzozów
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Poland
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Bydgoszcz
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Poland
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Kraków
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Poland
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Lublin
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Poland
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Pozna?
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Poland
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Warszawa
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Spain
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Cordoba
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
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Burnley
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United Kingdom
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Colchester, Essex
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United Kingdom
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Gillingham
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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Sutton
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05805501
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-LaRoche
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: BO43936 https://forpatients.roche.com/
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Address
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Phone
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888-662-6728
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05805501
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