Periodic Reporting for period 1 - CARE1 (First line randomized study platform to optimize treatment in patients with metastatic renal cell carcinoma)
Periodo di rendicontazione: 2023-05-01 al 2024-10-31
Much progress has been achieved in the past decade in the therapy of metastatic renal cell carcinoma by integrating immune checkpoint inhibitors into the treatment algorithm. Randomized clinical trials have demonstrated improved patient outcomes with combined regimens containing either drugs targeting different immune checkpoints or an immune checkpoint inhibitor with a targeted agent compared with the hitherto standard of care sunitinib. However, none of the industry-sponsored trials has compared the efficacy of the two strategies of combination therapy. The proposed trial aims at closing this knowledge gap and will compare the combination of immune checkpoint inhibitors ipilimumab and nivolumab with one of the combination regimens of a targeted agent with immune checkpoint inhibitor.
Untreated metastatic renal cell carcinoma patients will be randomized between the combination of ipilimumab and nivolumab and one of the standard regimens combining an immune checkpoint inhibitor with a targeting agent. Outcomes will be compared in a multicenter and multinational European trial. The results will inform the current and future practice of management of metastatic renal cell carcinoma. A large database of trial patients will also create an opportunity for related research in metastatic renal cell carcinoma including the prognostic and predictive biomarkers and other aspects of patient management.
Since its launch in May 2023, the CARE1 project has made remarkable progress, achieving key milestones and advancing its objectives. As of October 2024, the consortium has successfully submitted 19 deliverables to the EU Commission and achieved four project milestones.
To ensure efficient project oversight, five Management Board meetings have been conducted quarterly during this 18-month period. A major regulatory milestone was reached on December 12, 2023, with the submission of the CARE1 Pragmatic Clinical Trial (PCT) for approval via the Clinical Trial Information System (CTIS) Portal, in compliance with EU Regulation 536/2014. Approval was granted on April 2, 2024, and the first patient was enrolled shortly thereafter on April 12, 2024.
By the close of the first reporting period on October 31, 2024, two countries—France and the Czech Republic—had initiated patient recruitment for the trial (WP1), with 66 participants enrolled to date. Meanwhile, all work packages are progressing in alignment with the implementation of the Pragmatic Clinical Trial, ensuring the project's steady advancement toward its objectives. Biological and data collection is ongoing in the trial - central review of the biomarker status is done continuously throughout recruitment to ensure the feasibility of the trial.
Since its launch in May 2023, the CARE1 project has made remarkable progress, achieving key milestones and advancing its objectives. As of October 2024, the consortium has successfully submitted 19 deliverables to the EU Commission and achieved four project milestones.
To ensure efficient project oversight, five Management Board meetings have been conducted quarterly during this 18-month period. A major regulatory milestone was reached on December 12, 2023, with the submission of the CARE1 Pragmatic Clinical Trial (PCT) for approval via the Clinical Trial Information System (CTIS) Portal, in compliance with EU Regulation 536/2014. Approval was granted on April 2, 2024, and the first patient was enrolled shortly thereafter on April 12, 2024.
By the close of the first reporting period on October 31, 2024, two countries—France and the Czech Republic—had initiated patient recruitment for the trial (WP1), with 66 participants enrolled to date. Meanwhile, all work packages are progressing in alignment with the implementation of the Pragmatic Clinical Trial, ensuring the project's steady advancement toward its objectives. Biological and data collection is ongoing in the trial - central review of the biomarker status is done continuously throughout recruitment to ensure the feasibility of the trial.
The results of the trial will fill an important knowledge gap leading to more precise guidelines of the medical management of metastatic renal cell carcinoma. Beyond this, a model for a large multinational European academic clinical trial will be created that could be used to clarify other important issues in medical oncology. Collaborations created will also foster translational research activities not only in renal cell carcinoma, but also in other tumors with unmet medical need.