Is NCT04598009 recruiting in La Jolla, CA?

Yes, NCT04598009 is currently recruiting participants at its La Jolla, CA location. This melanoma clinical trial is actively enrolling qualified participants.

How do I join the melanoma clinical trial in La Jolla?

To join this clinical trial in La Jolla, 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 La Jolla 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.

Melanoma Clinical Trial in La Jolla, CA

About This Melanoma Study in La Jolla

This phase II trial studies how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery (unresectable). Binimetinib and imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and imatinib may help treat patients with KIT-mutant melanoma.

Sponsor: University of California, San Francisco

Who Can Participate

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)

Have histologically or cytologically confirmed melanoma

Have unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines, not amenable to local therapy

Have measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria

Have documentation of KIT-mutant melanoma by Clinical Laboratory Improvement Act (CLIA)-certified testing platform

Participants have progressed on prior standard-of-care therapy, or would be ineligible for or unable to tolerate standard-of-care therapy, in the opinion of the treating Investigator

For participants who have received prior ICI, the following is permitted:

Prior adjuvant or neoadjuvant ICI, if last dose administered at least 4 weeks prior to study drug start

Prior ICI for the treatment of unresectable/metastatic disease, if last dose administered at least 4 weeks prior to study drug start

Absolute neutrophil count \>= 1,500/microliter (mcL)

Platelets \>= 100,000/mcL

Total bilirubin below normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) =\< 3 x institutional upper limit of normal

Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)) =\< 3 x institutional upper limit of normal

Creatinine =\< 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \>= 50 mL/min calculated using the Cockcroft-Gault formula

Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy, with undetectable viral load within 3 months of study drug start, are eligible for this trial

For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS)-specific treatment is not required prior to study start

Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Imatinib and/or binimetinib may have teratogenic effects. Women of child-bearing potential (WOCBP) must agree to:

Use highly effective contraception to avoid pregnancy from screening through 30 days after the last dose of study drugs;

Refrain from donating ova during the study through 30 days after the end of systemic exposure to study drugs;

Inform her treating physician immediately should she become pregnant or suspect she is pregnant while she is participating in this study

Sexually active men enrolled on this protocol must agree to:

Use a condom for the duration of study participation and through 90 days after the end of systemic exposure to study drugs;

Refrain from donating sperm during the study through 90 days after the end of systemic exposure to study drugs;

If the male participant has a partner that is a WOCBP, that partner should also use highly effective contraception for the duration of the study and through 90 days after the end of the male participant's systemic exposure to study drug

Inform his treating physician immediately should his partner become pregnant while he is participating in this study Highly effective (i.e., failure rate \<1% per year when used consistently and correctly) methods of contraception include:

Complete abstinence from heterosexual intercourse

Combined (estrogen and progesterone) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)

Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)

Intra-uterine device (IUD)

Intrauterine hormone-releasing system (IUS)

Bilateral tubal occlusion

Vasectomized male partner (provided the vasectomized male has received medical assessment of surgical success, and that the male is a female participant's sole sexual partner)

Ability to understand a written informed consent document, and the willingness to sign it

The participant is deemed by the Investigator to have the initiative and means to be compliant with scheduled visits, treatment plan, and study procedures

Exclusion Criteria

Has received systemic anti-cancer therapies within 3 weeks of study drug start, radiation within 2 weeks, antibody therapy within 4 weeks

Has not recovered from adverse events due to prior anti-cancer therapy to =\< grade 1 or baseline. Note: Stable chronic conditions (grade =\< 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll

Is currently receiving any other investigational agents or has received an investigational agent within 14 days or within 5 half-lives of investigational agent (whichever is shorter), prior to start of study drugs

Inability to swallow and retain study drugs

Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drugs (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, complete small bowel resection), or recent (=\< 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs

Hypersensitivity to binimetinib or any of its excipients

Hypersensitivity to imatinib or any of its excipients

Concurrent neuromuscular disorder that is associated with elevated creatinine-kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)

History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity of hypercoagulability syndromes); history of retinal degenerative disease

Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:

History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty of stenting) \< 6 months prior to screening;

Congestive heart failure requiring treatment (New York Heart Association grade \>= 2);

Left ventricular ejection fraction (LVEF) \< 50% as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO);

Uncontrolled hypertension defined as persistent systolic blood pressure \>= 150 mmHg or diastolic blood pressure \>= 100 mmHg despite current therapy;

History of presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);

Triplicate average baseline corrected QT (QTc) interval \>= 480 msec

Use of a prohibited medication (including herbal medications, supplements, or foods) that cannot be safely discontinued prior to the start of study treatment

Patients on warfarin who cannot be safely transitioned to an alternative systemic anticoagulant

History of thromboembolic or cerebrovascular events =\< 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli. Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks prior to study drug start. Note: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled

Pregnant women are excluded from this study because binimetinib and imatinib are small molecule inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with binimetinib and/or imatinib, breastfeeding should be discontinued prior to study drug start

Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study

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 La Jolla?

Yes, this clinical trial (NCT04598009) has an active research site in La Jolla, CA 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.

Melanoma Treatment Options in La Jolla, CA

If you're searching for melanoma treatment options in La Jolla, CA, this clinical trial (NCT04598009) 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 La Jolla research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced 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 melanoma clinical trials near you to find additional studies recruiting in your area.

Melanoma Clinical Trial in La Jolla, CA

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