Neoadjuvant Darovasertib in Primary Uveal Melanoma

Ideaya Biosciences

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Uveal Melanoma

Treatments: Procedure: Primary Local Therapy; Drug: Darovasertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07015190

IDE196-010

Details and patient eligibility

About

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma

Full description

The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.

In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm).

In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation.

Subjects will then receive primary local therapy following neoadjuvant darovasertib.

All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

Enrollment: 520 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary non-metastatic uveal melanoma
• Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
• ECOG 0 or 1
• Adequate organ function

Exclusion criteria

• Previous treatment for UM
• Evidence of metastatic UM
• Attributes that necessitate enucleation regardless of response to therapy
• Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
• Presence of a malignant disease other than the one being treated in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

520 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)

Treatment:

Drug: Darovasertib

Control Arm

Active Comparator group

Description:

Immediate Primary Local therapy

Treatment:

Procedure: Primary Local Therapy