Ipilimumab and Imatinib Mesylate in Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT01738139|
Recruitment Status : Recruiting
First Posted : November 30, 2012
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Imatinib Mesylate Biological: Ipilimumab||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Ipilimumab (Immunotherapy) and Imatinib Mesylate (c-Kit Inhibitor) in Patients With Advanced Malignancies|
|Actual Study Start Date :||February 19, 2013|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: Treatment (ipilimumab, imatinib mesylate)
Patients receive ipilimumab IV over 90 minutes on day 1 and imatinib mesylate PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Imatinib Mesylate
- Incidence of adverse events [ Time Frame: Up to 7 years ]
- Maximum tolerated dose (MTD) [ Time Frame: 84 days ]MTD determined as the highest dose level with less than 2 patients with dose limiting toxicity (DLT) out of at least six patients in the cohort. DLT determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738139
|Contact: David Hongfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: David S. Hong 713-563-1930|
|Principal Investigator: David S. Hong|
|Principal Investigator:||David S Hong||M.D. Anderson Cancer Center|