IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Active:	Yes
Cancer Type:	Melanoma	NCT ID:	NCT05987332
Trial Phases:	Phase II Phase III	Protocol IDs:	IDE196-002 (primary) NCI-2023-07337
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	IDEAYA Biosciences
NCI Full Details:	http://clinicaltrials.gov/show/NCT05987332

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.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.