DYP688 for Metastatic Uveal Melanoma

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anticoagulants, Chemotherapy, Immuno-oncologics

Disqualifiers: Other malignancies, Active brain metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial requires stopping certain cancer treatments before starting the study drug. Specifically, you must stop fluoropyrimidine therapy 2 weeks before, radiation therapy 4 weeks before, and other cancer therapies like chemotherapy or immunotherapy 4 to 6 weeks before, depending on the type. The protocol does not specify about non-cancer medications, so you should discuss this with the study team.

Eligibility Criteria

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.

Inclusion Criteria

You have advanced uveal melanoma and have either not received treatment before or have tried other treatments that did not work. If you have non-uveal melanoma, it must have spread and not responded to standard treatments, and you must have a specific GNAQ/11 mutation.

I am at least 18 years old, or over 12 for phase II, and weigh at least 40 kg.

For the phase II trial, patients with advanced uveal melanoma that has not responded to standard treatments or for whom there are no other treatment options may be eligible. Also, patients with certain mutations in cutaneous or mucosal melanomas and no other effective treatment options may be eligible.

+2 more

Exclusion Criteria

I haven't had specific cancer treatments recently before starting the study treatment.

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

I have active brain metastases or leptomeningeal disease.

+3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Dose Escalation

Dose escalation to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of DYP688 in patients with metastatic uveal melanoma and other GNAQ/11 mutant melanomas

9 months

Phase II: Treatment

Treatment of patients in different groups: tebentafusp-naïve, tebentafusp-pre-treated, and non-uveal melanoma based on emerging data

17 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

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.

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