Phase 2 Melanoma Trial, Recruiting NCT05361174 Sponsor: Iovance Biotherapeutics, Inc. Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT05361174
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 been diagnosed with Stage IIIC, IIID, or IV melanoma that cannot be removed by surgery or has spread to other parts of the body, or Stage III or IV non-small cell lung cancer (NSCLC).
  • People with melanoma whose cancer has continued to grow within 12 weeks of stopping a specific type of immunotherapy (anti-PD-1/PD-L1), and who have also received a targeted treatment (BRAF/MEK inhibitor) if their tumour has a BRAF gene mutation.
  • People with NSCLC who have received no more than 3 previous cancer treatments, and whose cancer has either grown within 12 weeks of stopping immunotherapy (anti-PD-1/PD-L1), or — for those with a specific gene-driven tumour — has grown during or after at least one targeted therapy and/or chemotherapy.
  • People who are in relatively good general health and are able to carry out daily activities with little or no limitation (known as ECOG performance status 0 or 1).
  • People who have at least one tumour that surgeons assess as being able to be removed.
  • People who still have at least one measurable tumour remaining after one lesion is removed for the trial treatment preparation.
  • People whose heart, liver, kidneys, and other organs are functioning well enough to meet the trial's health requirements.
  • People who are willing to complete required heart function tests, and possibly lung function tests if needed.
  • People who are able to have children, or whose partners are able to have children, and who are willing to use a reliable form of contraception during treatment and for up to 12 months afterwards.
  • People over 70 years of age may be considered for the trial after a discussion between the treating doctor and the trial's medical oversight team (confirm with trial site).

Who may not be able to join:

  • People whose melanoma started in the eye (uveal or ocular melanoma).
  • People who have brain metastases (cancer that has spread to the brain) that are causing symptoms and have not yet been treated.
  • People who have had an organ transplant from another person, or any cell-based therapy that involved preparatory chemotherapy, within the past 20 years.
  • People who require ongoing steroid medication at a dose of 10 mg per day of prednisone or an equivalent steroid.
  • People who have a condition where their immune system does not work properly from birth or by nature (primary immunodeficiency).
  • People who have been diagnosed with another separate cancer within the past 3 years.
  • People who have received, or are due to receive, a live or weakened live vaccine within 28 days before starting the trial's preparatory treatment phase.

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 21 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: Iovance Biotherapeutics Study Team, Iovance Biotherapeutics

Phone: 1-844-845-4682

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
Iovance Biotherapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
20 July 2022
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Phase I: Safety of IOV-4001; Phase 2: Objective Response Rate (ORR)

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: 21 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