Malignant Melanoma Clinical Trial
Official title:
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
RATIONALE:Anti-melanoma activity of Ipilimumab both as a single therapy and in association
with melanoma peptides has been shown as well as synergy between radiation therapy and
anti-CTLA-A mAb in several tumor animal models for both local tumor control and distant
effects.Radiotherapy increases tumor immunogenicity in several preclinical models by
increasing MHC molecules expression and is able to induce significant tumor reduction in
around 30% of cases. Thus, combining radiotherapy and administration of ipilimumab could
elicit systemic antitumor response. Radiation therapy will expose tumor-associated antigens
(TAA) and facilitate antigen presentation, and further blockade of CTLA-4 could amplify the
immune antitumor response. In this therapeutical model, the use of the own patient tumor as
a source of tumor antigens (in opposition with other vaccination protocols, where TAA are
exogenic) is particularly adapted.
PURPOSE: This Phase I trial determines the side effects and best dose of radiation therapy
administered in combination with ipilimumab.
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
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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