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RecruitingLast updated: 16 August 2024

DAR-UM-2: This study is evaluating the safety and effectiveness of the combination of two targeted therapies compared with Investigator's choice of treatment (which may include immunotherapy or chemotherapy) in people with metastatic uveal (ocular) melanomaIDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma

Clinical summary

Summary

This study is evaluating targeted therapy (Darovasertib, also called IDE196) in combination with another type of targeted therapy (called Crizotinib) compared to the comparator arm of Investigator's choice of treatment (either pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

The Phase 2a dose optimisation stage will evaluate two doses of IDE196 in combination with crizotinib comapred to the comparator arm. Participants will be randomly allocated 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 seelcted, 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 randomly allocated 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 randomised to the two treatment arms.

Conditions

This trial is treating patients with metastatic uveal melanoma that is HLA-A*02:01 negative

Cancer

Skin Cancers Skin

Age

People18+

Phase

II/III

Trial Acronym

DAR-UM-2

More information

Trial Identifiers

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Trial sponsor

IDEAYA Biosciences

Scientific Title

IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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