Clinical Trials Logo

Clinical Trial Summary

This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody PF-04518600 work in treating patients with kidney cancer that has spread to other parts of the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made from living organisms that may may stimulate the immune system in different ways and stop tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody PF-04518600 may work better in treating patients with kidney cancer.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination. SECONDARY OBJECTIVES: I. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) and overall survival (OS) improve as a result of treatment with combination of axitinib + anti-OX40 antibody PF-04518600 (PF-04518600 [OX40 Ab]) compared to axitinib + placebo. TERTIARY OBJECTIVES: I. To determine whether pre and post treatment specimens collected during the trial demonstrate significant changes in tumor microenvironment and enhanced immune response to tumor cells. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-14 and anti-OX40 antibody PF-04518600 intravenously (IV) over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30, 90, and 180 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03092856
Study type Interventional
Source University of Southern California
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 19, 2017
Completion date July 19, 2025

See also
  Status Clinical Trial Phase
Completed NCT03163667 - CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC) Phase 2
Withdrawn NCT02307474 - A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Cancer N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT00101114 - Sorafenib and Interferon Alfa in Treating Patients With Metastatic or Unresectable Kidney Cancer Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Recruiting NCT05363631 - Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab Phase 1/Phase 2
Terminated NCT01198158 - Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy Phase 3
Completed NCT00378703 - Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer Phase 2
Recruiting NCT06138496 - Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC Phase 2
Recruiting NCT06088134 - Contrast-enhanced CT-based Deep Learning Model for Preoperative Prediction of Disease-free Survival (DFS) in Localized Clear Cell Renal Cell Carcinoma (ccRCC)
Recruiting NCT06049576 - Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma Phase 1
Active, not recruiting NCT01038778 - Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer Phase 1/Phase 2
Recruiting NCT05536141 - A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors Phase 1
Recruiting NCT05119335 - A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1/Phase 2
Completed NCT01243359 - Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies Phase 1
Terminated NCT00098618 - Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer Phase 2
Recruiting NCT05620134 - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer Phase 1/Phase 2
Recruiting NCT06052852 - Study of BDC-3042 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies Phase 1/Phase 2
Completed NCT03680521 - Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma Phase 2
Recruiting NCT06195150 - Overtaking Intra and Inter Tumoral Heterogeneity In Von Hippel-Lindau Related Renal Cancer