Phase 3 Melanoma Trial, Recruiting NCT05868707 Sponsor: Binhui Biopharmaceutical Co., Ltd. Condition: Melanoma
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Phase 3 Melanoma Trial, Recruiting

NCT05868707
Recruiting Phase 3

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 of age or older
  • You have been diagnosed with stage III or stage IV melanoma (confirmed by lab testing) and have already tried at least two standard treatments, such as chemotherapy, immunotherapy, or targeted therapy, without success
  • You have a good general level of daily functioning, with little to no limitation on activities (confirm with trial site)
  • Your doctors expect you to live for more than 3 months
  • It has been at least 4 weeks since your last cancer treatment, and any side effects from previous treatment have largely resolved
  • You have at least one measurable tumor that can also be injected directly, meeting specific size requirements (confirm with trial site)
  • If you have cancer that has spread to the brain, it must be stable, not causing symptoms, not getting worse, and you must not have needed steroid medication for at least 4 weeks
  • Your blood counts, kidney function, liver function, and blood clotting are all within acceptable ranges based on recent lab tests (confirm with trial site)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the trial
  • Both men and women who could father or become pregnant must use effective contraception during the trial and for 3 months afterward
  • If you have a history of genital herpes, at least 3 months must have passed since your last outbreak
  • You are willing to sign a consent form and are expected to follow the trial requirements

Who may not be able to join:

  • You have serious ongoing health conditions such as uncontrolled diabetes, a severe active infection, or an active stomach or intestinal ulcer
  • You have significant heart or blood vessel problems, including severe heart failure, a recent heart attack (within the last 6 months), uncontrolled irregular heartbeat, or poorly controlled high blood pressure (systolic 160 mmHg or higher and/or diastolic 100 mmHg or higher)
  • You had a heart stent placed within the last 6 months
  • You have a history of melanoma that started in the eye (uveal melanoma), or have had another type of cancer in the past 5 years (with some exceptions for certain early-stage skin or cervical cancers)
  • You have a large amount of fluid buildup in your chest or abdomen that is causing symptoms
  • You have bone metastases that are not stable or controlled by treatment (confirm with trial site)
  • You have an active autoimmune disease that has required medication to control it within the past 2 years (routine hormone replacement therapy does not count)
  • You have HIV, another immune deficiency condition, or have had an organ transplant
  • You have active hepatitis B or hepatitis C with detectable virus levels in your blood
  • You have active tuberculosis or another infection that needs ongoing treatment throughout your whole body
  • You have a known history of substance abuse, alcoholism, or drug misuse
  • You have taken part in another clinical trial or received antiviral therapy within the past 4 weeks (with a specific exception for some hepatitis B patients)
  • You have received a live vaccine within the 4 weeks before starting the trial
  • You are currently pregnant or breastfeeding
  • The trial doctor has any other reason to believe you should not participate

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 19 July 2026
Phase 3: approximately ~65% 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: 15111009972

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 3
Sponsor
Binhui Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
8 March 2023
Est. completion
1 March 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall survival (OS)

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: 19 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