BridgeMD
New treatment option for Metastatic Kidney Cancer
Official title CARE1 Pragmatic Clinical Trial
ClinicalTrials.gov ID: NCT06364631
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic kidney cancer.
Also referred to as OPDIVO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI.
- Phase 3: a large, late-stage study
- Time commitment: about 4 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
- Intermediate- or poor-risk mRCC as defined by IMDC classification.
- Adult male or female patients (≥ 18 years of age at inclusion).
- Karnofsky Performance Status (KPS) ≥70%.
- Adequate organ and marrow function, according to investigator assessment and
You likely can't join if
- Prior systemic anticancer therapy for mRCC including investigational agents. Note: One prior systemic adjuvant therapy is allowed for completely...
- Uncontrolled brain metastases (adequately treated with radiotherapy and/or radiosurgery prior to randomization are eligible). people who are...
- Concomitant oral anti-vitamin K anticoagulation. An exception is the use of LMWH or direct oral anticoagulants (DOAC), if considered safe by...
- The subject has uncontrolled, significant intercurrent or recent illness such as the following conditions: a. Cardiovascular disorders: i. Congestive...
- Pregnant or breastfeeding females.
- Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active...
See the full eligibility criteria
- Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
- Intermediate- or poor-risk mRCC as defined by IMDC classification.
- Adult male or female patients (≥ 18 years of age at inclusion).
- Karnofsky Performance Status (KPS) ≥70%.
- Adequate organ and marrow function, according to investigator assessment and
- Absolute neutrophil count (ANC) ≥ 1000/μL (≥ 1.5 GI/L)
- Platelets ≥ 100,000/μL (≥ 100 GI/L)
- Hemoglobin ≥ 8 g/dL (≥ 80 g/L)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
- Calculated creatinine clearance ≥ 30 mL/min (≥ 0.67 mL/sec) using the CKD- EPI equation
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
- Patient should be able and willing to comply with study visits and procedures as per protocol
- Patients must be affiliated to a social security system or beneficiary of the same
- Female patients must either be of non-reproductive potential or must have a negative serum pregnancy test within 14 days prior to the administration of study drug. Childbearing potential women must have agreed to use...
- Fertile men with a female partner of childbearing potential must agree to use one barrier method of contraception, such as condom, during treatment on this trial and for up to 4 months after the last dose of treatment...
- Female people of childbearing potential must not be pregnant at screening.
- 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...
- Uncontrolled brain metastases (adequately treated with radiotherapy and/or radiosurgery prior to randomization are eligible). people who are neurologically symptomatic as a result of their CNS metastasis or are...
- Concomitant oral anti-vitamin K anticoagulation. An exception is the use of LMWH or direct oral anticoagulants (DOAC), if considered safe by investigator assessment.
- The subject has uncontrolled, significant intercurrent or recent illness such as the following conditions: a. Cardiovascular disorders: i. Congestive heart failure (CHF) class III or IV as defined by the New York Heart...
- Pregnant or breastfeeding females.
- Any other active malignancy at 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...
- Hypersensitivity to any of the active substances or to any of the excipients administered during the study
- Use of live vaccines within 28 days before randomization
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Brno, Czechia
- Hradec Králové, Czechia
- Olomouc, Czechia
- Prague, Czechia
- Angers, France
- Avignon, France
- Bayonne, France
- Besançon, France
- Bordeaux, France
- Caen, France
- Chalon-sur-Saône, France
- Clermont-Ferrand, France
- Créteil, France
- Dijon, France
- Grenoble, France
- La Roche-sur-Yon, France
- Lille, France
- Limoges, France
- Lyon, France
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Brno, Czechia; Hradec Králové, Czechia; Olomouc, Czechia; Prague, Czechia; Angers, France and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.