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Adjuvant nivolumab treatment in stage II high-risk melanoma – A randomized, controlled, phase III trial with biomarker-based risk stratification (NivoMela)
EU CTIS ID: 2023-509394-23-00
What this study is testing
The primary objective of this trial is to determine efficacy of nivolumab in a biomarker-selected high-risk-enriched stage II melanoma patient population in comparison to control receiving observation only in a 2 (Arm A=nivolumab) :1 (Arm B=observation) randomization, as measured by Relapse-Free Survival (RFS). RFS is defined as the time from the date of registration until documented tumor recurrence date or date of death of any cause, whichever occurs first. In addition, patients not being selected as highrisk in the biomarker test (= Arm C) and who will be observed as in Arm B will be followed for RFS, too in order to evaluate the utility of the MelaGenix assay.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed diagnosis of stage II (AJCCv8) melanoma arising from a primary cutaneous site after surgery therapy
- Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration: o White blood cells (WBC) ≥ 2000/μL o Neutrophils ≥ 1500/μL o Platelets ≥ 100 x10^3/μL o Hemoglobin ≥ 9.0 g/dL o Serum creatinine ≤ 1.5xUL o Creatinine clearance (CrCl) ≥ 40mL/min (using the Cockcroft-Gault formula) o AST / ALT ≤ 3 x ULN o Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dL)
- Negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) for women of childbearing potential (WOCBP) within 72 hours prior to registration. Women will be considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or being post-menopausal for at least 24 months or being amenorrheic for > 12 months and folliclestimulating hormone (FSH) levels ≥ 40 IU/L.
- WOCBP and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to CTFG during the course of this study and for at least 5 months after last dose of study medication (in Arm A only).
- Sentinel node biopsy without detection of melanoma deposits
- Registration not later than 12 weeks after SNB procedure
You likely can't join if
- History of primary uveal or mucosal melanoma
- Active immune deficiencies or significant autoimmune disease
- Serious cardiac, gastrointestinal, hepatic or pulmonary disease which would reduce life expectancy to less than five years
- Serious intercurrent illness, requiring hospitalization
- Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other active chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of stage II (AJCCv8) melanoma arising from a primary cutaneous site after surgery therapy
- Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration: o White blood cells (WBC) ≥ 2000/μL o Neutrophils ≥ 1500/μL o Platelets ≥ 100 x10^3/μL o Hemoglobin ≥ 9.0 g/dL o Serum creatinine ≤ 1.5xUL o Creatinine clearance (CrCl) ≥ 40mL/min (using the Cockcroft-Gault formula) o AST / ALT ≤ 3 x ULN o Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dL)
- Negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) for women of childbearing potential (WOCBP) within 72 hours prior to registration. Women will be considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or being post-menopausal for at least 24 months or being amenorrheic for > 12 months and folliclestimulating hormone (FSH) levels ≥ 40 IU/L.
- WOCBP and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to CTFG during the course of this study and for at least 5 months after last dose of study medication (in Arm A only).
- Sentinel node biopsy without detection of melanoma deposits
- Registration not later than 12 weeks after SNB procedure
- Tumor tissue from primary tumor must be provided for biomarker analyses. In order to be registered, a patient must be classified by MelaGenix risk analysis.
- Men and women at the age of 18 to 80 years
- Signed written, informed consent
- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Minimum life expectancy of five years excluding their melanoma diagnosis
- ECOG performance status of 0-1
What rules you out
- History of primary uveal or mucosal melanoma
- Active immune deficiencies or significant autoimmune disease
- Serious cardiac, gastrointestinal, hepatic or pulmonary disease which would reduce life expectancy to less than five years
- Serious intercurrent illness, requiring hospitalization
- Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other active chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
- Hypersensitivity to the active substance or to any of the excipients
- Participation in another clinical study within the 30 days before registration
- For female patients: Pregnancy or breast-feeding
- For WOCBP and male patients with partners of childbearing potential: Refusal or inability to use effective means of contraception
- No access to sufficient tumor tissue of primary tumor
- Lack of availability for clinical follow-up assessments
- Legal incapacity or limited legal capacity
- SNB procedure > 12 weeks before registration
- Prior active malignancy within the previous 3 years except for locally curable cancers that have been apparently cured, such as: basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, or breast. Exception. Participants with a history of non-ulcerated cutaneous/acral primary melanoma <1 mm in depth with no nodal involvement are allowed in this trial
- Prior or planned therapy with Interferon alpha, CTLA4 or PD-1 / PD-L1 antibodies
- Use of any investigational or non-registered product (drug or vaccine) other than the study treatment
- Administration of live vaccines within 4 weeks before start of study therapy
- Any immunosuppressive therapy given within the past 30 days
- Active psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.