A Dose Escalation Phase I Study of Radiotherapy Administered in Combination With Anti-CTLA4 Monoclonal Antibody (Ipilimumab) in Patients With Unresectable Stage III or Stage IV Advanced Malignant Melanoma
OBJECTIVES:
Primary: To determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and
recommended Phase 2 dose of radiation therapy administered in combination with ipilimumab.
Secondary:
Adverse event profiles Preliminary anti-tumor activity following escalating doses of
radiation combined to ipilimumab using the immune related response criteria irRC overall
survival in patients treated with this combination systemic immunologic anti tumor response
intratumoral immune response pharmacodynamic effects of ipilimumab and radiotherapy in
combination on Absolute Lymphocyte Count (ALC) associations between ALC and anti-tumor
activity of ipilimumab and radiotherapy in combination
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose of radiation therapy administered in combination with ipilimumab
To determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) andrecommended Phase 2 dose of radiation therapy administered in combination with ipilimumab.
between week 4 and week 10
Yes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CSET 2010/1663 -Mel-Ipi-Rx
NCT01557114
March 2011
March 2014
Name | Location |
---|