Phase 2 Melanoma Trial, Recruiting NCT06229340 Sponsor: N.N. Petrov National Medical Research Center of Oncology Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT06229340
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 who are able to give informed consent and sign the required study forms
  • People who are 18 years of age or older
  • People whose cancer-related physical functioning falls within a certain range, meaning they are either fully active, have some limitations but can care for themselves, or are up and about more than half of waking hours (confirm with trial site)
  • People who have been confirmed by tissue testing to have stage 4 (metastatic) cancer that has spread to other parts of the body
  • People who have a confirmed RAS gene mutation (specifically KRAS, HRAS, or NRAS) identified by a tumour tissue test within the last 5 years
  • People who have already received more than 2 different standard cancer drug treatments
  • People whose cancer has been shown to be growing or spreading based on standard imaging measurement criteria (RECIST version 1.1)
  • People whose blood counts, kidney function, and liver function meet certain minimum levels — including adequate white blood cells, platelets, red blood cells, kidney filtering ability, and liver markers (confirm specific values with trial site)
  • Women who could become pregnant and who agree to either abstain from heterosexual intercourse or use at least two highly effective forms of contraception during treatment
  • People who have brain metastases (cancer that has spread to the brain) that are not causing symptoms, where the treating doctor has determined that targeted local treatment is not needed

Who may not be able to join:

  • People who are over 85 years of age
  • People who currently have an active infection, whether recent or ongoing
  • People with significantly reduced kidney or liver function, or a heart pumping function below 45%
  • People with a known history of hepatitis B or C (due to potential effects of one of the study drugs, leflunomide, on the liver)
  • People who have had an allergic reaction to leflunomide, teriflunomide, or chemically similar compounds used in the treatment combination
  • People with serious uncontrolled health conditions, such as active infection, heart failure, unstable chest pain, heart rhythm problems, or mental health or social circumstances that could affect participation in the study
  • People who are pregnant or breastfeeding, due to potential risks from the study treatments
  • People with a history of certain eye conditions, such as retinal tears, bleeding in the eye, retinal vein blockage, or certain other retinal diseases — or people with current risk factors such as uncontrolled glaucoma or a history of blood-thickening conditions (confirm with trial site)

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 27 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: Evgeny Imyanitov, N.N. Petrov NMRC of Oncology

Phone: +79013023707

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
N.N. Petrov National Medical Research Center of Oncology
Registry
ClinicalTrials.gov
Start date
3 October 2023
Est. completion
1 October 2026

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Objective response 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: 27 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