Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
Phase II Randomized Double Blind Trial of PF-04518600, an OX40 Antibody, in Combination With Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients With Metastatic Renal Cell Carcinoma
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03163667 -
CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)
|
Phase 2 | |
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
| Withdrawn |
NCT02307474 -
A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Cancer
|
N/A | |
| 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 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 |
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
|
||
| Active, not recruiting |
NCT02293980 -
A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
|
Phase 1 |