Metastatic Melanoma Clinical Trial
Official title:
A Phase 1b, Open-label, Dose Escalation Study Investigating Different Doses of SGI-110 in Combination With Ipilimumab in Unresectable or Metastatic Melanoma Patients
Thi pahse I, dose-escalation trial will determine the MTD, safety and the additional benefit achieved from adding SGI-110 to ipilimumab therapy in metastatic melanoma patients. Preclinical evidence generated with SGI-110 in vivo demonstrated that besides having a direct activity on tumor growth as a single agent, SGI-110 was able to "sensitize" neoplastic cells to the anti-tumor activity of CTLA-4 blockade, providing a sound scientific rationale to develop new immunotherapeutic approaches combining SGI-110 with therapeutic mAb to immune check-points.
Epigenetic alterations play a pivotal role in cancer development and progression.
Pharmacologic reversion of such alterations is feasible, and second generation "epigenetic
drugs" are in development and have demonstrated to possess significant immunomodulatory
properties. This knowledge, together with the availability of new and highly effective
immuno-therapeutic agents including immune check-point(s) blocking monoclonal antibodies,
allows us to plan for highly innovative proof-of-principle combination studies that will
likely open the path to more effective anti-cancer therapies.
Targeting immune check-point(s) with immunomodulatory monoclonal antibody (mAb) is a novel
and rapidly evolving strategy to treat cancer, that is rapidly spreading to different tumor
histologies. The prototype approach of this therapeutic modality relies on the inhibition of
negative signals delivered by CTLA-4 expressed on T lymphocytes. CTLA-4 blockade has
profoundly changed the therapeutic landscape of metastatic melanoma (MM), significantly
improving the survival of MM patients; however, objective clinical responses are limited,
and only a minority of patients achieves long-term disease control.1 Therefore, several
combination approaches are being explored to improve the efficacy of CTLA-4 blockade. Along
this line, based on the preclinical evidence the investigators gained on the broad
immunomodulatory activity of SGI-110, the exploratory phase 1 combination study NIBIT-M4 has
been designed to provide proof-of-concept evidence to the immunologic and clinical efficacy
of CTLA-4 blockade combined with DNA-HypomethylatingAgent (DHA). Progressing Stage III or
Stage IV MM patients, amenable to serial tumor biopsies will be enrolled in the study.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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|
Phase 3 | |
| Active, not recruiting |
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Phase 1 | |
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Phase 2 | |
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Phase 2 | |
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Phase 3 | |
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Phase 1/Phase 2 | |
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Phase 1 | |
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Phase 4 |