Is NCT03947385 recruiting in Denver, CO?

Yes, NCT03947385 is currently recruiting participants at its Denver, CO location. This uveal melanoma clinical trial is actively enrolling qualified participants.

How do I join the uveal melanoma clinical trial in Denver?

To join this clinical trial in Denver, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Denver clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Uveal Melanoma Clinical Trial in Denver, CO

About This Uveal Melanoma Study in Denver

This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2

Sponsor: IDEAYA Biosciences

Who Can Participate

Inclusion Criteria

Patient must be ≥18 years of age and able to provide written informed consent

Diagnosis of the following: o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most recent therapy was an immune-oncology agent, PD must be confirmed. \- If a patient is treatment naïve and human leukocyte antigen (HLA)-A\*02:01 positive\*\*\*, documentation is required to provide rationale why treatment with tebentafusp is not the ideal firstline treatment approach or of the patient's intolerance to tebentafusp. \*\*\*To be enrolled in the HLA-A\*02:01 positive cohort, HLA status must be documented by test results from a CAP/CLIA-certified laboratory.

Measurable disease per RECIST v1.1

Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \> 3 months

Adequate organ function at screening

Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential Crizotinib Combination Additional Inclusion Criteria:

Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib

Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib Biopsy-eligible patients

Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.

Exclusion Criteria

Previous treatment with a PKC inhibitor

Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors

Known symptomatic brain metastases

Adverse events from prior anti-cancer therapy that have not resolved

Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus

Active infection requiring ongoing therapy

Recent surgery or radiotherapy

Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect

Females who are pregnant or breastfeeding

Impaired cardiac function

Treatment with prohibited medications that cannot be discontinued prior to study entry

For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin Crizotinib Combination Additional Exclusion Criteria:

Prior therapy directly targeting ALK, MET, or ROS1

Spinal cord compression

History of pneumonitis or interstitial lung disease

History of syncope

History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment PK Substudy (optional) with Pravastatin Additional Exclusion Criteria:

Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1

Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin

Any contraindication associated to the use of statins or hypersensitivity component of pravastatin

Active liver disease DDI Cocktail Substudy Additional Exclusion Criteria:

Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.

Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit/grapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.

Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.

Moderate and strong inhibitors of CYP2A4/5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.

Intake of strong or moderate inducers of CYP3A4/5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Denver?

Yes, this clinical trial (NCT03947385) has an active research site in Denver, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Uveal Melanoma Treatment Options in Denver, CO

If you're searching for uveal melanoma treatment options in Denver, CO, this clinical trial (NCT03947385) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Denver research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced uveal melanoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all uveal melanoma clinical trials near you to find additional studies recruiting in your area.

Uveal Melanoma Clinical Trial in Denver, CO

Expert Care in Denver

IRB Approved

No-Cost Care

Apply for This Denver Location

Why Participate?

Simple Process