Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
Phase I/II Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
This is a phase I/II open-label study designed to evaluate the combination of pembrolizumab and cabozantinib in subjects with locally advanced, recurrent, or metastatic renal cell carcinoma. Sequential dose escalation of cabozantinib with standard dose pembrolizumab will occur in the phase I dose escalation part of the study to determine the recommended phase 2 dose (RP2D). Subsequently, subjects will receive cabozantinib at the RP2D in combination with pembrolizumab in the phase II dose expansion part of the study.
Primary Objectives - To determine the efficacy based on objective response rate [ORR = complete response (CR) + partial response (PR)] of pembrolizumab and cabozantinib when administered in combination in subjects with locally advanced or metastatic renal cell carcinoma.. Secondary Objectives - To characterize dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) for the combination. - To assess other measures of anti-tumor activity of the combination of pembrolizumab and cabozantinib in subjects with locally advanced or metastatic renal cell carcinoma. ;
| 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 | |
| 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| Withdrawn |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 | |
| Completed |
NCT00848640 -
Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma
|
Phase 2 |