Phase 2 Melanoma Trial, Recruiting NCT07136181 Sponsor: Novelwise Pharmaceutical Corporation Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT07136181
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older
  • You have been diagnosed with metastatic uveal melanoma (a type of eye cancer that has spread), confirmed by a tissue or cell sample
  • Your cancer can be measured on a scan, following standard medical guidelines
  • You are well enough to carry out everyday activities, with only mild limitations at most (confirm with trial site)
  • You have had previous cancer treatments; there is no limit on how many prior treatments you have received
  • If you have a specific genetic marker called HLA-A*02:01, you must have previously received a treatment called tebentafusp, unless it was unavailable or not suitable for you (confirm with trial site)
  • You have recovered from most or all side effects of previous cancer treatments, and enough time has passed since your last treatment
  • Your heart's electrical activity (measured by an ECG) is within an acceptable range
  • Your blood counts are at acceptable levels — including red blood cells, platelets, and white blood cells — and you are not dependent on blood transfusions
  • Your liver is functioning well enough, based on blood test results
  • Your kidneys are functioning well enough, based on blood test results
  • If you are able to have children (male or female), you have agreed to use two reliable forms of contraception during the study and for 6 months after your last dose
  • You are willing and able to attend scheduled visits and follow the study plan

Who may not be able to join:

  • You are pregnant or currently breastfeeding
  • You are receiving other cancer treatments at the same time that are not part of this trial (such as chemotherapy, radiation, or other targeted therapies)
  • You have had another type of cancer in the past 3 years, with some exceptions for certain low-risk cancers (confirm with trial site)
  • You have an active or uncontrolled infection, or a serious illness that would make it difficult to safely take part
  • You have a medical condition or finding that could make the study drug unsafe for you or make the results hard to interpret (confirm with trial site)
  • You have difficulty swallowing tablets or capsules
  • You are currently taking certain medications that strongly affect how a liver enzyme called CYP2C8 works (for example, a drug called gemfibrozil) — confirm your current medications with the trial site
  • You have tested positive for hepatitis B or hepatitis C, unless the virus level in your blood is undetectable
  • You have had a heart attack, severe chest pain, heart bypass surgery, heart failure, or a stroke (including a mini-stroke) within the past 3 months
  • You are taking or expected to need certain medications that affect drug transport in the body (called P-gp or BCRP inhibitors) — confirm with trial site
  • You have taken stomach acid-reducing medications (such as proton pump inhibitors or H2 blockers) within the 7 days before starting the trial, or plan to take them during the trial, unless you are able to switch to a suitable antacid taken at specific times around your dose (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1 (910) 297-9045

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Novelwise Pharmaceutical Corporation
Registry
ClinicalTrials.gov
Start date
20 November 2025
Est. completion
28 March 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Phase Ib: Incidence of dose-limiting toxicities (DLTs); Phase Ib: Maximum Tolerated Dose (MTD); Phase II: Objective Response Rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov