Renal Cell Carcinoma Clinical Trial
Official title:
A Phase II Trial of Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
This is a single-arm phase II trial evaluating the combination of avastin and temsirolimus in patients with metastatic renal cell cancer (RCC) including both histologically confirmed clear cell (cc) or non-clear cell (ncc) subtypes. Patients must have experienced disease progression or intolerable toxicity with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) (e.g. sorafenib, sunitinib, pazopanib). Only 2 prior VEGF therapies are allowed. The purpose of this research study is to evaluate efficacy of the combination against an historical control. Temsirolimus has been approved by the Food and Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been approved by the FDA for other types of cancers but not renal cell carcinoma.
Avastin, a humanized IgG1 monoclonal antibody (MAb), inhibits vascular endothelial growth
factor (VEGF). VEGF is one of the most potent and specific proangiogenic factors and has been
identified as a crucial regulator of both normal and pathological angiogenesis. Temsirolimus
specifically inhibits the mammalian target of rapamycin (mTOR), a highly conserved
serine/threonine kinase which regulates cell growth and metabolism in response to
environmental factors. The combination avastin and temsirolimus has already demonstrated
efficacy in the phase I setting
STATISTICAL CONSIDERATIONS:
The primary endpoint is 4-month PFS. The null and alternative hypotheses are 50% vs. 70%.
Assuming 2 ineligible patients, the target sample size is 41 patients (39 eligible patients).
The probability of concluding that the treatment is effective was >0.90 if the true rate is
at least 70%. The probability of concluding that the treatment is effective was ≤ 0.10 if the
true rate was 50% or less. If 24 or more patients are alive and progression-free at 4 months,
then this regimen would be considered for further study.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04987203 -
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
|
Phase 3 | |
Recruiting |
NCT06391879 -
Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
Completed |
NCT02853344 -
Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
|
Phase 2 | |
Terminated |
NCT04088500 -
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT05070637 -
Circulating Tumor Cell Reducing No-touch Nephrectomy
|
N/A | |
Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
Not yet recruiting |
NCT06049030 -
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT01358721 -
Phase I Biomarker Study (BMS-936558)
|
Phase 1 | |
Active, not recruiting |
NCT04503148 -
Anesthesia and Cancer Study: Renal Cell Carcinoma
|
N/A | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Not yet recruiting |
NCT05808608 -
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03323710 -
Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma
|
Phase 2 | |
Not yet recruiting |
NCT02787915 -
DC1s-CTL Cellular Therapy for Renal Cell Carcinoma
|
Phase 1/Phase 2 |