Phase 1 Melanoma Trial, Recruiting NCT07224425 Sponsor: Boehringer Ingelheim Condition: Melanoma
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Phase 1 Melanoma Trial, Recruiting

NCT07224425
Recruiting Phase 1

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:

  • People with a confirmed solid tumour diagnosis (Part A) who have already tried all available treatments known to help their condition, or for whom no proven treatment options exist.
  • People with a confirmed solid tumour diagnosis (Part B) whose cancer has continued to grow or who could not tolerate standard treatments, and who have received no more than 3 previous treatment courses (not counting certain pre- or post-surgery treatments or a specific cell-based therapy called tumour-infiltrating lymphocytes). A genetic test result for a protein called BRAF must be available before joining.
  • People who are generally well enough to carry out light activity and care for themselves, rated 0 or 1 on a standard health scale used in cancer trials (called ECOG performance status).
  • People who have at least one measurable area of cancer located outside the brain or spinal cord, as seen on scans.
  • People aged 18 years or older.
  • People whose organs (such as kidneys and liver) are functioning adequately (confirm with trial site for specific requirements).
  • People whose life expectancy is at least 3 months at the time of starting the trial, in the opinion of the treating doctor.
  • People whose side effects from previous cancer treatments have mostly resolved to mild or no symptoms before joining, with some exceptions allowed for hair loss, nerve-related symptoms, and certain menstrual changes.

Who may not be able to join:

  • People with active brain or spinal cord cancer, untreated cancer that has spread to the brain, or cancer affecting the lining of the brain — although people with brain metastases that are not causing symptoms may still be considered if radiation or surgery was completed at least 2 weeks before starting the trial, and they have been off steroids for at least 7 days and off or on stable doses of anti-seizure medication for at least 7 days (confirm with trial site).
  • People with an immune system disorder, or those who have been taking immune-suppressing medications — including steroid doses higher than a low daily threshold — within 7 days before starting the trial.
  • People who have received other cancer treatments within 28 days (or within 5 half-lives of that treatment, whichever is shorter) before starting the trial, or who have had extensive radiation therapy including whole-brain radiation within 2 weeks before starting.
  • People who have previously had an organ transplant or a stem cell transplant.
  • People taking blood-thinning medications that cannot be safely paused if a medical procedure such as a biopsy becomes necessary, in the opinion of the treating doctor.
  • Women who are pregnant, breastfeeding, or who plan to become pregnant or breastfeed during the trial or within 4 months after the last dose of the trial treatment.

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 22 July 2026
Phase 1: approximately ~10% 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: 1-800-243-0127

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 1
Registry
ClinicalTrials.gov
Start date
24 February 2026
Est. completion
5 October 2029

Where this trial is recruiting

🇧🇪 Belgium 🇳🇱 Netherlands 🇺🇸 United States

Primary endpoints

Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the Maximum Tolerated Dose (MTD) evaluation period; Part A (dose escalation): Occurrence of Dose Limiting Toxicity (DLTs) during the MTD evaluation period; Part B (dose expansion): Objective Response (OR)

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: 22 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