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

Overview

About this study

The purpose of this study is to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR), and to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to OS

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an
inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11

- Concurrent malignant disease

- AEs from prior anti-cancer therapy that have not resolved to Grade ≤1

- Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases
that require corticosteroids

- Active HIV infection or Hep B/C

- Active adrenal insufficiency, active colitis, or active inflammatory bowel disease

- History of interstitial lung disease, active pneumonitis, or history of pneumonitis

- Active infection requiring systemic antibiotic therapy

- Use of hematopoietic colony-stimulating factors (CSF) prior to start of study drug

- Females who are pregnant or breastfeeding

- History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs
or monoclonal antibodies

- Contraindication for treatment with investigator's choice therapies as per applicable
labelling

- Has any other condition that may increase the risk associated with study participation
or may interfere with the interpretation of study results and, in the opinion of the
investigator, would make the participant inappropriate for entry into the study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/13/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arkadiusz Dudek, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20567688

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