Phase 2 Melanoma Trial, Recruiting NCT06965231 Sponsor: Fudan University Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT06965231
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 are reasonably active and able to care for yourself with little or no help with daily activities (confirm with trial site)
  • You have been diagnosed with skin or acral (hands/feet) melanoma that has been confirmed by a tissue or cell sample — mucosal (inside body) and eye melanomas do not qualify
  • You have been tested for specific gene changes (BRAF, CKIT, and NRAS)
  • You have not received any cancer treatment before for this condition
  • Your melanoma is at clinical Stage II (based on a specific staging system from 2017)
  • Your blood counts, liver, kidney, and clotting results are within acceptable ranges (confirmed through recent lab tests)
  • Your heart is pumping blood effectively enough (at least 50% efficiency, confirmed by ultrasound)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before joining, not be breastfeeding, and agree to use contraception during the study and for 6 months after
  • If you are a man, you must agree to use contraception during the study and for 6 months after
  • You are willing to take part, sign a consent form, and follow the study's requirements

Who may not be able to join:

  • You have had an allergic reaction to biological medicines in the past
  • You have had another cancer in the past 5 years (exceptions may apply for certain fully cured skin cancers or cervical pre-cancers — confirm with trial site)
  • You have an active autoimmune disease or a history of certain autoimmune conditions (such as autoimmune liver disease, lung inflammation, bowel inflammation, or asthma needing regular medication — some milder conditions like vitiligo or controlled thyroid problems may be exceptions)
  • You have taken strong immune-suppressing steroids (equivalent to more than 10mg of prednisone per day) in the 2 weeks before starting the trial
  • You have a history of significant bleeding problems, had a serious bleeding episode in the last 4 weeks, or have unhealed wounds, broken bones, active stomach ulcers, or other conditions that could cause bleeding or bowel perforation
  • You have poorly controlled high blood pressure (top number 150 or above, or bottom number 90 or above)
  • You have had unstable chest pain, a heart attack, significant heart failure, or a heart rhythm problem requiring treatment in the past 6 months
  • You have an active or poorly controlled serious infection
  • You have active hepatitis B or C with detectable virus levels in your blood, advanced liver disease, or HIV
  • You have poorly controlled diabetes
  • You have significant protein in your urine (confirm with trial site)
  • You have received a live vaccine in the 4 weeks before treatment or expect to need one during the study
  • You have other serious health conditions, mental health conditions, or personal circumstances that the study doctors believe could affect your safety or the study results

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 26 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: Chunmeng Wang, Dr., Fudan University

Phone: +86 13671976170

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
Registry
ClinicalTrials.gov
Start date
1 January 2025
Est. completion
30 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

2-year recurrence-free survival rate (2-year RFS rate)

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: 26 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