Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases
This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC).
Cabozantinib is a small molecule inhibitor of tyrosine kinases which include MET (hepatocyte growth factor receptor protein), VEGFR (vascular endothelial growth factor receptors), AXL, RET (Rearranged during transfection), FLT3 (Fms-like tyrosine kinase-3), KIT (mast/stem cell factor receptor), ROS1, MER, TYRO3, TRKB (Tropomyosin receptor kinase B) and TIE-2 (angiopoietins receptor). Similar to other TKIs, cabozantinib is a reversible, ATP-competitive inhibitor. Cabozantinib has thus demonstrated significant activity in metastatic clear cell renal cell carcinoma after failure of one or 2 tyrosine kinase inhibitors and is now approved in the second line setting in Europe. Some efficacy was also demonstrated in patients in first line treatment when compared to sunitinib. Brain metastasis in renal cancer are difficult to treat and cytotoxic systemic therapies are still not used, given by the more or less impermeable blood-brain barrier. The interest of cabozantinib in brain renal cell carcinoma metastases is encouraged by 3 recent cases reports of significant responses of brain metastases including a complete response of brain metastases in one case. Moreover MET receptor surexpression appear more frequent in brain metastases than in other renal cell carcinoma tumor sites. Cabozantinib as multitarget inhibitor including VEGF and MET receptors suggest that it could be a good option. Its efficacy in brain metastases from renal cell carcinoma requires further evaluation. On this basis, the investigators propose to conduct an open-label exploratory single arm, multicenter prospective phase II trial to assess the efficacy of cabozantinib on brain metastases in metastatic renal cell carcinoma patients. Ancillary studies: The relationship between serum markers and efficacy data will be investigated. Serum and plasma sample will be collected at Baseline. MET expression and MET sequencing will be also performed on available tumor tissues. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00930033 -
Clinical Trial to Assess the Importance of Nephrectomy
|
Phase 3 | |
| Recruiting |
NCT05863351 -
Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
|
Phase 3 | |
| Not yet recruiting |
NCT06284564 -
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
|
Phase 2 | |
| Completed |
NCT00414765 -
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
|
Phase 4 | |
| Active, not recruiting |
NCT03149822 -
Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03647878 -
Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
|
||
| Completed |
NCT01517243 -
Phase II Study of Alternating Sunitinib and Temsirolimus
|
Phase 2 | |
| Withdrawn |
NCT03927248 -
PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT02122003 -
Second Line Sorafenib After Pazopanib in Patients With RCC
|
Phase 2 | |
| Completed |
NCT01182142 -
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
|
Phase 2 | |
| Completed |
NCT00630409 -
Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 | |
| Completed |
NCT04076787 -
Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
|
||
| Active, not recruiting |
NCT04467021 -
Cancer and Blood Pressure Management, CARISMA Study
|
N/A | |
| Recruiting |
NCT05119335 -
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02282579 -
Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
|
||
| Completed |
NCT01731158 -
Sequential Therapy in Metastatic Renal Cell Carinoma
|
Phase 2 | |
| Terminated |
NCT02071641 -
Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Terminated |
NCT01342627 -
Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT01274273 -
Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer
|
Phase 2 |