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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mrs
Charlotte
Ackerman
-
bci-care1@qmul.ac.uk
Prof
Thomas
Powles
+44 7932 048 109
bci-CARE1@qmul.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Metastatic renal cell carcinoma
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Treating kidney cancer (renal cell carcinoma, RCC) uses two main types of drugs: 1. targeted therapies (anti-angiogenic drugs) that block signals that help tumors grow new blood vessels, like vascular endothelial growth factor tyrosine kinase inhibitors (VEGFR TKIs); and, 2. immunotherapies that boost the immune system by targeting proteins like Human programmed death-1/Human programmed death ligand-1 (PD1/PDL1) or Cytotoxic T-lymphocyte associated protein 4 (CTLA4). For clear cell RCC (a common type of RCC), combining these treatments is the standard approach. This study aims to determine if two immunotherapy drugs together (ICI-ICI) improve overall survival (OS) in PDL1-positive patients and if one immunotherapy drug with targeted therapy (ICI-VEGFR TKI) enhances both progression-free survival (PFS) and overall survival (OS) in PDL1-negative patients.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Prior systemic anticancer therapy for mRCC including investigational agents.Note: One prior systemic adjuvant therapy is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy.2. Uncontrolled brain metastases (adequately treated with radiotherapy and/or radiosurgery prior to randomization are eligible). Subjects who are neurologically symptomatic as a result of their CNS metastasis or are receiving systemic corticosteroid treatment (prednisone equivalent > 10 mg/day) at the planned time of randomization are not eligible.3. Concomitant oral anti-vitamin K anticoagulation. An exception is the use of LMWH or direct oral anticoagulants (DOAC), if considered safe by investigator assessment.4. The subject has an uncontrolled, significant intercurrent or recent illness such as the following conditions:4.1. Cardiovascular disorders:4.1.1. Congestive heart failure (CHF) class III or IV as defined by the New York Heart Association, unstable angina pectoris, myocardial infarction, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).4.1.2. Uncontrolled hypertension despite optimal antihypertensive treatment.4.1.3. Stroke, or other symptomatic ischemic event or severe thromboembolic event (e.g., symptomatic pulmonary embolism [PE], incidental PE is acceptable if deemed safe by the investigator) within 3 months before randomization.4.2. Active GI bleeding or symptomatic Gastrointestinal (GI) tract obstruction4.3. Clinically significant bleeding including uncontrolled hematuria, hematemesis, or hemoptysis4.4. Autoimmune disease that has been symptomatic or required immunosuppressive systemic treatment within the past two years from the date of randomization.Note: Patients with a history of Crohn’s disease or ulcerative colitis are always excluded4.5. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed.4.6. Active infection requiring systemic treatment.4.7. Major surgery (e.g., nephrectomy, GI surgery, removal of brain metastasis) within 4 weeks prior to randomization or serious non-healing wound/ulcer/bone fracture.5. Pregnant or breastfeeding females.6. Any other active malignancy at the time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured.7. Hypersensitivity to any of the active substances or to any of the excipients administered during the study8. Use of live vaccines within 28 days before randomization9. Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, social or psychological reasons.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Thomas
Powles
+44 7932 048 109
bci-CARE1@qmul.ac.uk
Mrs
Charlotte
Ackerman
-
bci-care1@qmul.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Institut Gustave Roussy and funded by HORIZON EUROPE Framework Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
