Phase 2 Melanoma Trial, Recruiting NCT05970497 Sponsor: Krystal Biotech, Inc. Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT05970497
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:

  • People with a life expectancy of more than 12 weeks
  • People with a good general level of physical functioning (rated 0 or 1 on a standard medical scale, meaning able to carry out normal daily activities with little or no restriction)
  • People who have at least one area of disease that can be measured on a scan at the start of the trial
  • For groups 1–4 only: People with a confirmed advanced or spreading solid tumour that has worsened after standard treatment, where standard treatment was not tolerated, where the person declined standard treatment, or where no standard treatment exists
  • For groups 5 and 6 only: People with confirmed stage III (cannot be surgically removed) or stage IV melanoma who have previously tried one type of immunotherapy treatment (anti-PD-1/PD-L1) that did not work, and — if their melanoma has a specific gene change called BRAF V600 — have also previously tried a targeted therapy for that gene change
  • For group 5 only: People aged 12 years or older at the time of giving consent
  • For group 6 only: People aged 18 years or older at the time of giving consent

Who may not be able to join:

  • People who have not fully recovered from a previous surgery or radiation therapy, including any ongoing side effects from radiation, or who still need steroid medicines as a result
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study treatment or within three months after the last dose of the study drug
  • People with a known history of HIV (HIV 1/2)
  • For groups 5 and 6 only: People who have another cancer that is actively growing or being treated
  • For groups 5 and 6 only: People with a type of eye-related melanoma called uveal or ocular melanoma
  • For groups 5 and 6 only: People with active cancer spread to the brain or the lining around the brain or spinal cord
  • For groups 5 and 6 only: People who have already received more than two rounds of systemic (whole-body) treatment for unresectable or metastatic melanoma
  • For groups 5 and 6 only: People who had to permanently stop anti-LAG-3 or anti-PD-1 immunotherapy in the past because it caused intolerable side effects

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 28 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

Principal Investigator: David Chien, MD, Senior Vice President of Clinical Development

Phone: 412-586-5830

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
Krystal Biotech, Inc.
Registry
ClinicalTrials.gov
Start date
31 October 2023
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of adverse events (AEs); Percentage of serious adverse events (SAEs)

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: 28 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