Clinical Trials Logo

Clinical Trial Summary

This phase I/II trial studies the side effects of sitravatinib and how well it works with nivolumab in treating patients with kidney cancer that has spread to other places in the body. Sitravatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sitravatinib and nivolumab may work better in treating patients with kidney cancer.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the toxicities (defined as a grade 3 or 4 National Cancer Institute [NCI] non-hematologic or hematologic adverse event, within 12 weeks from treatment initiation), and efficacy (defined as achieving complete remission, partial remission, or stable disease within 6 weeks) of sitravatinib (MGCD516) when administered orally (PO) daily in combination with standard dose nivolumab 240 mg/kg every 2 weeks. SECONDARY OBJECTIVES: I. To estimate the overall survival (OS), progression-free survival (PFS) times, objective response rates (ORR), and quality of life (QOL) of patients with advanced clear cell renal cell cancer (RCC) treated with the combination of MGCD516 and nivolumab. II. Evaluate potential biomarkers for patient stratification and treatment response, including genetic analysis, serum cytokines and chemokines, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity. OUTLINE: Patients receive sitravatinib PO once daily (QD) on days 1-14 and receive nivolumab intravenously (IV) over 60 minutes on day 1 starting cycle 2. Cycles repeat every 14 days for cycles 1-6 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients who receive at least 6 infusions of nivolumab with no dose limiting toxicities (DLTs) related to nivolumab, may then receive nivolumab every 4 weeks. After completion of study treatment, patients are followed up at 30 days and then every 3 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03015740
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 23, 2017
Completion date September 6, 2022

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