IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
18 Years and older, Male and Female
IDE196-002 (primary)
NCI-2023-07337
Summary
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen
(HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be
randomized to receive either IDE196 + crizotinib or investigator's choice of treatment
(pembrolizumab, ipilimumab + nivolumab, or dacarbazine).
Objectives
This study is designed as a multi-stage Phase 2 study within a Phase 3 study to evaluate
the safety, tolerability, pharmacokinetics, dose-exposure relationship, and anti-tumor
activity of IDE196 in combination with crizotinib compared to the comparator arm of
investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or
dacarbazine).
The Phase 2a dose optimization stage will evaluate two doses of IDE196 in combination
with crizotinib compared to the comparator arm. Participants will be randomized to the
three treatment arms. At the point of optimal IDE196 + crizotinib dose selection, the
other dose arm will be dropped with discontinuation of enrollment to that arm.
Participants receiving the IDE196 dose (in combination with crizotinib) that is not
selected, will be offered the choice to remain on the same dose or change to the chosen
optimal dose.
The optimal dose will be chosen to complete the Phase 2b portion. The Phase 2b part of
the study will continue to enroll the chosen combination dose of IDE196 + crizotinib
compared with the comparator arm. Participants will be randomized to the two treatment
arms.
The Phase 3 part of the study will continue to enroll the chosen combination dose of
IDE196 + crizotinib compared with the comparator arm. Participants will be randomized to
the two treatment arms.
Eligibility
- Histological or cytological confirmed Metastatic Uveal Melanoma
- HLA-A*02:01 negative
- No prior systemic therapy in the metastatic or advanced setting, regional or liver-directed therapy, ablations or surgical resection of oligometastatic disease, or neoadjuvant or adjuvant therapy is allowed
- Measurable disease per RECIST 1.1
- Able to be safely administered and absorb study therapy
- ECOG performance status 0 or 1
- Life expectancy of =3 months
- Adequate organ function
Treatment Sites in Georgia
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