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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05805501




Registration number
NCT05805501
Ethics application status
Date submitted
28/03/2023
Date registered
10/04/2023

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
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
Secondary ID [1] 0 0
BO43936
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
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)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to death from any cause (up to 35 treatment cycles; cycle length = 21 days)
Secondary outcome [2] 0 0
Confirmed Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 35 treatment cycles (cycle length = 21 days)
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
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)

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital; The Adem Crosby Centre - Birtinya
Recruitment hospital [2] 0 0
ICON Cancer Care Adelaide - Kurralta Park
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
China
State/province [10] 0 0
Beijing City
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Nanjing City
Country [13] 0 0
China
State/province [13] 0 0
Tianjin
Country [14] 0 0
China
State/province [14] 0 0
Xi'an
Country [15] 0 0
France
State/province [15] 0 0
Avignon
Country [16] 0 0
France
State/province [16] 0 0
Besançon Cedex
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Caen
Country [19] 0 0
France
State/province [19] 0 0
Lyon
Country [20] 0 0
France
State/province [20] 0 0
Villejuif
Country [21] 0 0
Germany
State/province [21] 0 0
Dresden
Country [22] 0 0
Germany
State/province [22] 0 0
Hamburg
Country [23] 0 0
Germany
State/province [23] 0 0
Hannover
Country [24] 0 0
Germany
State/province [24] 0 0
München
Country [25] 0 0
Germany
State/province [25] 0 0
Nürtingen
Country [26] 0 0
Germany
State/province [26] 0 0
Tübingen
Country [27] 0 0
Germany
State/province [27] 0 0
Ulm
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Goyang-si
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Jeollanam-do
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Poland
State/province [31] 0 0
Brzozów
Country [32] 0 0
Poland
State/province [32] 0 0
Bydgoszcz
Country [33] 0 0
Poland
State/province [33] 0 0
Kraków
Country [34] 0 0
Poland
State/province [34] 0 0
Lublin
Country [35] 0 0
Poland
State/province [35] 0 0
Pozna?
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Spain
State/province [37] 0 0
Cordoba
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Burnley
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Colchester, Essex
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Gillingham
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Manchester
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Nottingham
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Plymouth
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Sutton
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-LaRoche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO43936 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05805501