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RecruitingLast updated: 22 January 2024

This phase I/II study is seeking to determine the best dose level, safety and effect, of a new cancer drug (DYP688) in people with metastatic ocular (uveal) melanomaA Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas

Clinical summary

Summary

There will be two parts to this study: a phase I, dose escalation part followed by a phase II part. Dose escalation will be conducted in people with metastatic uveal melanoma (MUM) and other melanomas with GNAQ/11 mutations. Once the maximum tolerated dose (MTD) and/or recommended doses (RD) is determined in the dose escalation part, the study may continue with a phase II part. The phase II part will be conducted in two groups of participants with MUM, a group that has received prior treatment with tebentafusp, and a group that has not received prior treatment with tebentafusp. In addition to MUM, a third group of participants with a non-uveal GNAQ/11 mutant melanomas may also be explored. This cohort may be opened based on emerging data from teh dose escalation part of the study.

Conditions

This trial is treating patients with metastatic uveal (ocular) melanoma, and other melanomas harbouring GNAQ/11 mutations

Cancer

Multi-Cancer Multi-Cancer

Age

People12+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas

Eligibility

Inclusion

  • Patients in the dose escalation part must be ≥ 18 years of age at the time of informed consent (ICF) signature. In the phase II part, patients ≥ 12 years of age at the time of informed consent may be eligible for enrollment (not applicable in countries where enrollment is restricted by the local health authority to patients ≥ 18 years of age). Patients must have a minimum weight of 40 kg.
  • 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
  • Patients must be suitable and willing to undergo study required biopsies according to the treating institution's own guidelines and requirements. If a biopsy is not medically feasible, exceptions may be considered after documented discussion with Novartis.

For all patients in Dose Escalation

  • MUM: uveal melanoma with histologically or cytologically confirmed metastatic disease. Patient must be either treatment naive or have received any number of prior lines and progressed on most recent therapy
  • Non-MUM: advanced cutaneous or mucosal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following all standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 mutation based on local data

For patients in Phase II

  • Tebentafusp naïve group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies
  • Tebentafusp pre-treated group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease. Patients must be previously treated with tebentafusp and have progressed
  • Non-MUM: patients with diagnosis of cutaneous or mucosal melanomas harboring GNAQ/11 mutations based on local data, with histologically or cytologically confirmed metastatic disease that has progressed following all standard therapies or that has no satisfactory alternative therapies

Exclusion

  • Malignant disease, other than that being treated in this study.
  • Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease.
  • Evidence of active bleeding or bleeding diathesis or significant coagulopathy (including familial) or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
  • History of anaphylactic or other severe hypersensitivity / infusion reactions to ADCs or monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
  • Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:

    • 2 weeks for fluoropyrimidine therapy
    • 4 weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment.
    • 4 weeks or ≤ 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
    • 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosoureas and mitomycin C.
    • 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.
  • Clinically significant and / or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA grade ≥ 2) or clinically significant arrhythmia despite medical treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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.

Ask your doctor if this trial could be right for you.

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