Phase 2 Melanoma Trial, Recruiting NCT05423262 Sponsor: Toray Industries, Inc Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT05423262
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 confirmed advanced or spreading solid tumour cancer that has stopped responding to standard treatments, cannot tolerate standard treatments, or for whom no standard treatment exists (Part 1); or people with a confirmed advanced or spreading solid tumour who would normally be treated with a medicine called nivolumab (240mg every 2 weeks) as standard care (Part 2); or people with confirmed advanced, inoperable, or spreading melanoma (not the eye type) who have previously been treated with a chemotherapy called dacarbazine and for whom no standard treatment now exists (Part 3)
  • People with a life expectancy of at least 3 months after starting the study treatment
  • People aged 18 years or older at the time of giving consent
  • People who are able to give written consent in person to take part in the study
  • Women who could potentially become pregnant must have a negative pregnancy test before enrolling

Who may not be able to join:

  • People who have an active, uncontrolled bacterial, viral, or fungal infection that requires systemic (whole-body) treatment
  • Women who are pregnant, possibly pregnant (as assessed by their doctor), or currently breastfeeding — stopping breastfeeding in order to enrol is also not permitted
  • People who are unwilling or unable to follow the procedures required by the study protocol
  • People who test positive for HIV antibodies
  • People who test positive for hepatitis B surface antigen (a marker of hepatitis B infection)
  • People who test positive for hepatitis C virus RNA (a marker of active hepatitis C infection)

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 20 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: +81467-32-9948

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
Toray Industries, Inc
Registry
ClinicalTrials.gov
Start date
6 July 2022
Est. completion
1 December 2027

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2); Number of participants with adverse events (AEs) (Part 1 and 2); Number of participants with adverse events of special interest (AESIs) (Part 1 and 2); Number of participants with serious adverse events (SAEs) (Part 1 and 2); Objective response rate (ORR) (Part 3)

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: 20 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