Phase 2 Melanoma Trial, Recruiting NCT05546827 Sponsor: M.D. Anderson Cancer Center Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT05546827
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 have a mucosal tumour (a tumour on the moist lining of a body cavity) that can be seen on a physical exam or imaging scan.
  • People whose cancer has not spread to distant parts of the body.
  • People who are already planned to receive a combination immunotherapy treatment (such as ipilimumab and nivolumab, or nivolumab and relatlimab).
  • People who are reasonably well and able to carry out some daily activities (confirm with trial site regarding the specific activity level required).
  • People aged 18 years or older.
  • People of childbearing potential, and their male partners, who agree to use effective contraception throughout the trial and for a set period afterward — acceptable methods include hormonal contraception, an intrauterine device (IUD), surgical sterilisation, vasectomy, or condoms with spermicide; complete abstinence during the trial period is also accepted.
  • Men enrolled in the trial who agree to use effective contraception before, during, and for 6 months after completing radiation therapy.
  • People who have had or currently have another type of cancer, where that cancer or its treatment is not expected to interfere with safely receiving the treatments in this study.
  • People who are able to understand the trial and are willing to sign a written consent form.
  • For the sinonasal melanoma group (Arm 1): People who have been confirmed by biopsy or cell testing to have melanoma in the nasal cavity and/or sinuses, who have been assessed by a head and neck surgeon regarding whether surgery is possible, and who are able to have a baseline MRI scan of the skull base (unless there is a medical or financial reason they cannot).
  • For the anorectal melanoma group (Arm 2): People who have been confirmed by biopsy or cell testing to have melanoma in the anorectal canal, who have been assessed by a surgical team regarding surgical options, and who are able to have a baseline rectal MRI scan (unless there is a medical or financial reason they cannot).

Who may not be able to join:

  • People who have previously had radiation therapy to the area of the body that would be treated in this trial (the nose/sinus area for Arm 1, or the anorectal area for Arm 2).
  • People whose cancer has already spread (metastatic disease).
  • People who are currently pregnant.
  • People under 18 years of age.

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 12 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: Devarati Mitra, MD, M.D. Anderson Cancer Center

Phone: (713) 563-1339

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
23 September 2022
Est. completion
31 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of Pathologic Response

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: 12 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