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New treatment option for Cutaneous Melanoma, Stage III
Official title Neo-adjuvant Immunotherapy in Patients With Localized Melanoma
ClinicalTrials.gov ID: NCT07230613
What this study is testing
What is Ipilimumab (YervoyTM, 50 mg/10 mL solution)?
Ipilimumab (YervoyTM, 50 mg/10 mL solution) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous melanoma, stage iii.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response. Intratumoral (IT) delivery of immunostimulating agents reduces the systemic toxicity associated with monoclonal antibodies (mAbs) targeting immune checkpoints.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In addition to NEOREM Master Protocol inclusion and
You likely can't join if
- , the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial: Inclusion Criteria:
- Patients ≥ 18 years old.
- Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma.
- Patients who received anti-PD-1 and stopped treatment \> 6 months prior to their inclusion in NEO-1 trial are eligible.
- Patients who received target therapy and stopped treatment \> 3 months prior to their inclusion in NEO-1 trial are eligible. Exclusion Criteria:
- Patients with clinically or radiologically detectable distant metastases.
See the full eligibility criteria
- In addition to NEOREM Master Protocol inclusion and
- , the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial: Inclusion Criteria:
- Patients ≥ 18 years old.
- Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma.
- Patients who received anti-PD-1 and stopped treatment \> 6 months prior to their inclusion in NEO-1 trial are eligible.
- Patients who received target therapy and stopped treatment \> 3 months prior to their inclusion in NEO-1 trial are eligible. Exclusion Criteria:
- Patients with clinically or radiologically detectable distant metastases.
- Patients with uveal melanoma.
- Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and/ ipilimumab.
- Patients without pathological evaluable disease according to RECIST v1.1 criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Lyon, France
- Marseille, France
- Paris, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Lyon, France; Marseille, France; Paris, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.