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IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
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).
Study details:
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 criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-31
Primary completion: 2027-01-15
Study completion finish: 2028-01-15
Study type
TREATMENT
Phase
PHASE2
PHASE3
Trial ID
NCT05987332
Intervention or treatment
DRUG: IDE196
DRUG: Crizotinib
DRUG: Pembrolizumab
DRUG: Ipilimumab
DRUG: Nivolumab
DRUG: Dacarbazine
Conditions
- • Metastatic Uveal Melanoma
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
Westmead Hospital
Sydney, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Princess Alexander Hospital
Brisbane, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Phase 2a Dose Optimization of IDE196 + crizotinib
| DRUG: IDE196
|
EXPERIMENTAL: Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib
| DRUG: IDE196
|
ACTIVE_COMPARATOR: Phase 2a / 2b / 3 Comparator Arm
| DRUG: Pembrolizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Progression-Free Survival (PFS) by blinded independent central review (BICR) of IDE196 + Crizotinib compared to investigator's choice of treatment | PFS per RECIST 1.1 | Approximately 2 years |
Overall Survival (OS) of IDE196 + Crizotinib compared to investigator's choice of treatment | OS from randomization to date of death due to any cause | Approximately 4 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Safety of IDE196 + Crizotinib: Incidence of Adverse Events | Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs as measured by CTCAE V5.0 | Approximately 2 years |
Phase 2a: Dose exposure response of IDE196 | Dose-exposure-response of IDE196 as measured by concentration of IDE196 in plasma | Approximately 5 months |
Phase 2a: Dose exposure response of Crizotinib | Dose-exposure-response of Crizotinib as measured by concentration of Crizotinib in plasma | Approximately 5 months |
Progression-Free Survival (PFS) per Investigator of IDE196 + Crizotinib compared to investigator's choice of treatment | PFS per RECIST 1.1 | Approximately 2 years |
Objective Response Rate (ORR) per BICR and Investigator assessment of IDE196 + Crizotinib compared to investigator's choice of treatment | ORR per RECIST 1.1 | Approximately 2 years |
Duration of Response (DOR) per BICR and Investigator assessment of IDE196 + Crizotinib compared to investigator's choice of treatment | DOR per RECIST 1.1 | Approximately 2 years |
Change from baseline over time and between treatment arms in EORTC QLQ-C30 | Global health status and quality of life will be assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement. | Approximately 2 years |
Change from baseline over time and between treatment arms in EuroQoL (EQ)-5D-5L scores | General health status will be assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement. | Approximately 2 years |
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