BridgeMD
New treatment option for Cutaneous Melanoma
Official title Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
ClinicalTrials.gov ID: NCT06999980
What this study is testing
What is Ipilimumab 3mg/kg and nivolumab 1mg/kg?
Ipilimumab 3mg/kg and nivolumab 1mg/kg is an investigational medicine, being studied as a potential treatment for cutaneous melanoma.
Also referred to as Arm A.
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
- This clinical trial is for patients with stage 3 cutaneous melanoma and patients with mucosal melanoma who are able to have surgery to remove all tumour deposits. To improve the chance that melanoma will not recurr, new experimental combinations of a type of treatment called immunotherapy will be given before surgery.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
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
- COMMON Applicable to all 3 cohorts
- 1\. Written informed consent
- 2\. Male or female patients who are at least 18 years of age on the day of signing informed consent.
- 3\. Clinically detectable disease, and/or RECIST version 1.1 defined disease, and/or disease confirmed on PET imaging.
- 4\. Fully resectable disease defined as having no significant vascular, central nervous system or bony involvement. Only cases where a complete...
You likely can't join if
- Applicable to all 3 cohorts
- 1\. Uveal melanoma
- 2\. Any contraindication to the administration of relatlimab, ipilimumab or nivolumab
- 3\. No prior systemic therapy, including treatment with prior anti-PD1/L1, anti-CTLA-4 or anti-LAG-3 therapy (cohorts 1 and 3), except for cohort 2...
- 4\. A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
- Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)
See the full eligibility criteria
Who can join
- COMMON Applicable to all 3 cohorts
- 1\. Written informed consent
- 2\. Male or female patients who are at least 18 years of age on the day of signing informed consent.
- 3\. Clinically detectable disease, and/or RECIST version 1.1 defined disease, and/or disease confirmed on PET imaging.
- 4\. Fully resectable disease defined as having no significant vascular, central nervous system or bony involvement. Only cases where a complete surgical resection leading to tumour free margins and which is safely...
- 5\. Concurrent primary disease and lymph node metastases acceptable provided completely resectable.
- 6\. Up to 3 in-transit metastases are permitted as long as these are fully resectable.
- 7\. Tumour that is amenable to a newly obtained core biopsy for performance of the multi-omic predictive biomarker model
- 8\. ECOG performance status of 0 to 1.
- 9\. Adequate haematological, hepatic, renal and endocrine function
- 10\. An anticipated life expectancy of \>12 months.
- 11\. Women of child bearing potential (WOCBP) must agree to avoid pregnancy or breast feeding for the duration of study treatment.
- Cohort 1 only
- a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma
- b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma
- c. No prior systemic treatment for cutaneous melanoma
- d. Completion of the multi-omic predictive biomarker model within 14 days (7-10 business days) of planned randomisation.
- Cohort 2 only
- a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma
- b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma
- c. Disease progression on neoadjuvant anti-PD-1 monotherapy, where progressed disease is completely resectable or, disease recurrence on adjuvant anti-PD-1 monotherapy, where recurrent disease is completely resectable
- d. No prior treatment with CTLA-4 or LAG-3 inhibitors.
- Cohort 3 only
- a. Histologically confirmed diagnosis of mucosal melanoma
- b. Any stage of disease provided it is fully resectable
- c. No prior systemic treatment for mucosal melanoma COMMON
What rules you out
- Applicable to all 3 cohorts
- 1\. Uveal melanoma
- 2\. Any contraindication to the administration of relatlimab, ipilimumab or nivolumab
- 3\. No prior systemic therapy, including treatment with prior anti-PD1/L1, anti-CTLA-4 or anti-LAG-3 therapy (cohorts 1 and 3), except for cohort 2 which will have received anti-PD1 monotherapy only.
- 4\. A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days of...
- Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)
- Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose
- Non-absorbed intra-articular steroid injections.
- 5\. An active autoimmune disease that has required systemic treatment in the past 12 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). The following are permitted:
- Vitiligo
- Type I diabetes mellitus
- Residual autoimmune hypothyroidism on stable hormone replacement
- Resolved childhood asthma or atopy
- Psoriasis not requiring systemic treatment
- Autoimmune conditions which are not expected to recur in the absence of an external trigger.
- 6\. A known additional malignancy that is progressing or has required active treatment within the past 3 years. The following malignancies, if undergone successful definitive resection or curative treatment, are...
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy)
- Prostatic intraepithelial neoplasia
- In situ melanoma
- Atypical melanocytic hyperplasia
- Multiple primary melanomas
- Other malignancies for which the patient has been disease free for 1 year.
- 7\. A known CNS metastases and/or carcinomatous meningitis
- 8\. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease.
- 9\. Has an active infection requiring systemic therapy.
- 10\. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.
- 11\. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for...
- 12\. Has a known history of active TB (Bacillus Tuberculosis).
- 13\. Uncontrolled or significant cardiovascular disease including, but not limited to any of the following:
- Myocardial infarction (MI) or stroke/transient ischemic attack within the 6 months prior to consent
- Uncontrolled angina within the 3 months prior to consent
- Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- QTc prolongation \> 480 ms
- History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial...
- Cardiovascular disease-related requirement for daily supplemental oxygen
- History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure)
- Patients with history of myocarditis, regardless of aetiology.
- 14\. Patients with a \>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \<1 g/24 hours.
- 15\. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or...
- 16\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 17\. Pregnant or breast feeding females
- 18\. Concurrent medical or social conditions that may prevent the patient from attending assessments per schedule
The study team makes the final eligibility decision.
Where it's taking place
- Wollstonecraft, New South Wales, Australia
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 study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Wollstonecraft, New South Wales, Australia. 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.