What side effects are associated with this type of intervention?

Targeted therapies for Uveal Melanoma, such as those aimed at GNAQ/11 mutations like DYP688, are primarily in the investigational stages. Common side effects of similar targeted therapies can include fatigue, nausea, and ocular toxicities such as dry eye and conjunctivitis. Systemic chemotherapy, often used in metastatic cases, can cause neutropenia, fatigue, and peripheral neuropathies. Immunotherapy, another treatment option, may lead to immune-related adverse events including colitis, dermatitis, and endocrinopathies. It is crucial to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's specific needs.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting GNAQ/11 mutations in Uveal Melanoma. Traditional treatments for Uveal Melanoma include surgery, radiation therapy, and conventional chemotherapy. However, recent advancements in targeted therapies and immunotherapies are being explored in clinical trials, such as the study of DYP688, which aims to target GNAQ/11 mutations. These efforts represent a promising direction for more effective and personalized treatments for this rare form of melanoma.

What other types of research exist?

Promising alternatives to DYP688 for uveal melanoma patients with GNAQ/11 mutations include: 1) Immunotherapy agents such as pembrolizumab and nivolumab, which have shown efficacy in various melanoma subtypes. 2) Combination therapies involving MEK inhibitors (e.g., trametinib) and other targeted agents. 3) Clinical trials exploring novel agents targeting specific pathways involved in uveal melanoma, such as PKC inhibitors (e.g., AEB071) and YAP/TAZ inhibitors. Patients should discuss these options with their oncologist to determine the best course of action based on their specific case.

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DYP688 for Metastatic Uveal Melanoma

Q: What is the mechanism of action of this treatment?

The most common treatments for Uveal Melanoma, particularly those targeting GNAQ/11 mutations like DYP688, work by inhibiting specific molecular pathways that drive tumor growth and survival. These targeted therapies aim to block the signaling pathways activated by the mutated genes, thereby reducing tumor proliferation and inducing cancer cell death. This is crucial for Uveal Melanoma patients as it offers a more personalized and potentially effective treatment option compared to traditional therapies, which may not specifically target the underlying genetic drivers of the disease.

Phase 1 & 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤ 1 for patients ≥ 18 years of age; Karnofsky performance status ≥ 70 for patients ≥ 16 and < 18 years of age; Lansky performance status ≥ 70 for patients ≥ 12 and < 16 years of age

Be older than 18 years old

Must not have

Malignant disease, other than that being treated in this study.

Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called DYP688 to see if it can help treat patients with specific types of skin cancer that have certain genetic mutations. The study aims to find out if the drug is safe and effective in shrinking tumors in these patients.

Who is the study for?

This trial is for patients with metastatic uveal melanoma or other melanomas with GNAQ/11 mutations. Adults and, in some cases, children over 12 can join if they weigh at least 40 kg and are healthy enough (good performance status). They must be willing to undergo biopsies unless medically inadvisable. Patients should not have active brain metastases, significant bleeding risks, recent cancer treatments that could interfere, other cancers, severe allergies to similar drugs, or uncontrolled heart disease.

What is being tested?

The study is testing DYP688 as a single agent for its safety and effectiveness against certain types of advanced melanoma. It's an open-label trial meaning everyone knows what treatment they're getting. The first phase checks the right dose and the second phase sees how well it works on different groups including those who've had standard treatments or specific prior therapy.

What are the potential side effects?

While specific side effects of DYP688 aren't listed here, common ones for cancer treatments like this may include fatigue, nausea, allergic reactions to the drug infusion itself (like fever or chills), potential bleeding issues due to biopsies especially in people with clotting problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and can care for myself regardless of my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any cancer other than the one being treated in this study.

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I have active brain metastases or leptomeningeal disease.

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I do not have serious heart conditions that are not well-controlled.

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I do not have a bleeding disorder or a condition that requires long-term blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I (Dose Escalation): Frequency of dose interruptions, reductions, and discontinuations

Phase I (Dose Escalation): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Therapeutic procedure

+1 more

Secondary study objectives

Phase I (Dose Escalation): Best Overall Response (BOR) per RECIST v1.1

Phase I (Dose Escalation): Overall Response Rate (ORR) per RECIST v1.1

Phase I and Phase II: PK profile of DYP688 - Area under the concentration-time curve (AUC)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase II: Tebe pre-treatedExperimental Treatment1 Intervention

Patients with metastatic uveal melanoma that have been previously treated with tebentafusp

Group II: Phase II: Tebe naive groupExperimental Treatment1 Intervention

Patients with metastatic uveal melanoma that has not received prior treatment with tebentafusp

Group III: Phase II: Non-uveal melanomaExperimental Treatment1 Intervention

Optional Arm: To explore patients with non-uveal melanoma that harbor GNAQ or 11 mutations, based on emerging data from dose escalation

Group IV: Phase I: Dose EscalationExperimental Treatment1 Intervention

Patients with metastatic uveal melanoma or other GNAQ/11 mutant melanomas

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Uveal Melanoma, particularly those targeting GNAQ/11 mutations like DYP688, work by inhibiting specific molecular pathways that drive tumor growth and survival. These targeted therapies aim to block the signaling pathways activated by the mutated genes, thereby reducing tumor proliferation and inducing cancer cell death. This is crucial for Uveal Melanoma patients as it offers a more personalized and potentially effective treatment option compared to traditional therapies, which may not specifically target the underlying genetic drivers of the disease.

Emerging Gene Manipulation Strategies for the Treatment of Monogenic Eye Disease.Visual acuity and progression of macular atrophy in patients receiving intravitreal anti-VEGF for age-related macular degeneration.Complementary effects of bevacizumab and MMC in the improvement of surgical outcome after glaucoma filtration surgery.