Unresectable Stage III or Stage IV Melanoma Clinical Trial
Official title:
A Phase 1 Safety Pilot/Phase II, Open-label Study of Varlilumab (CDX-1127) in Combination With Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or Stage IV Melanoma
This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining a) varlilumab and ipilimumab and b) varlilumab, ipilimumab, CDX-1401 and poly-ICLC. The study will enroll patients with unresectable Stage III or Stage IV melanoma.
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found
on certain immune cells and may act to promote anti-tumor effects.
Yervoy™ (Ipilimumab) is a human monoclonal antibody that blocks CTLA-4, a protein receptor
that downregulates the immune system.
CDX-1401 is a vaccine made of a fully human monoclonal antibody linked to NY-ESO-1 and is
designed to deliver NY-ESO-1 to professional antigen presenting cells for generating robust
immune responses against cancer cells expressing NY-ESO-1. CDX-1401 is administered with
poly-ICLC, an adjuvant that enhances vaccine-induced immune responses.
This study will evaluate the safety, tolerability and efficacy of varlilumab and ipilimumab,
with or without the addition of CDX-1401/poly-ICLC, in patients with melanoma.
Eligible patients that enroll in the Phase I portion of the study will be assigned to one of
two possible dose levels of varlilumab in combination with 3 mg/kg ipilimumab. The first
phase of the study will test the safety profile of the combination and determine which dose
of varlilumab will be studied in Phase II of the study.
During Phase II, up to 48 patients whose tumors do not express NY-ESO-1, will receive the
recommended dose of varlilumab determined from Phase I with 3 mg/kg ipilimumab. Up to 24
patients whose tumors express NY-ESO-1 will receive the recommended dose of varlilumab
combined with 3 mg/kg ipilimumab and 1 mg CDX-1401 along with 2 mg poly-ICLC.
All patients enrolled in the study will be closely monitored to determine if there is a
response to the treatment as well as for any side effects that may occur.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00412828 -
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
|
Phase 1/Phase 2 |