Ipilimumab and Imatinib Mesylate in Advanced Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- C-KIT Tyrosine Kinase Protein Overexpression
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Metastatic Gastrointestinal Stromal Tumor
- Metastatic Malignant Solid Neoplasm
- Metastatic Melanoma
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Unresectable Melanoma
- Unresectable Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity profile of intravenous ipilimumab (Yervoy) administered in combination with oral imatinib mesylate (GLEEVEC) for patients with advanced malignancies that are refractory to standard therapy, relapsed after standard therapy, or have no availab...
PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity profile of intravenous ipilimumab (Yervoy) administered in combination with oral imatinib mesylate (GLEEVEC) for patients with advanced malignancies that are refractory to standard therapy, relapsed after standard therapy, or have no available standard therapy. II. To determine the maximum toxic dose (MTD) and dose limiting toxicities (DLT) of ipilimumab and imatinib mesylate combination therapy. SECONDARY OBJECTIVES: I. To determine antitumor activity of ipilimumab and imatinib mesylate combination therapy. II. To determine antitumor activity of ipilimumab and imatinib mesylate combination therapy in KIT confirmed solid tumors. III. To evaluate the potential predictive role of tumor-associated immune biomarkers for therapy effectiveness. IV. To evaluate the potential predictive role of therapy associated toxicities with antitumor activity. OUTLINE: This is a dose-escalation study. Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1 and imatinib mesylated orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT01738139
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: David S Hong M.D. Anderson Cancer Center