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New treatment option for High-risk Melanoma
Official title Assessment of Short Immunotherapy After Radical Surgery of High-risk Malignant Melanoma
ClinicalTrials.gov ID: NCT06488482
What this study is testing
What is nivolumab or pembrolizumab?
nivolumab or pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high-risk melanoma.
Also referred to as Opdivo and Keytruda.
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
- 1. Rational Every year, around 5,000 people in Sweden are diagnosed with malignant skin melanoma.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- Provision of written informed consent for participation.
- ≥ 18 years of age.
- Performance status ECOG/WHO 0-1.
- Adequate organ functions as per standards for immunotherapy.
- Radical surgery for CMM (including acral) stage IIb-c, III (including in transit) and IV. Stage III CMM patients with unknown primary and stage IIb-c...
You likely can't join if
- The patient is, in the opinion of the investigator, assessed as unfit to receive systemic adjuvant treatment.
- Serious and/or uncontrolled medical disorder that in the opinion of the investigator is contraindicated.
- An active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism requiring hormone replacement only and...
- Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease and liver cirrhosis).
- Inability to provide informed consent or refusal to do so.
- Inability to comply with the study protocol.
See the full eligibility criteria
- Provision of written informed consent for participation.
- ≥ 18 years of age.
- Performance status ECOG/WHO 0-1.
- Adequate organ functions as per standards for immunotherapy.
- Radical surgery for CMM (including acral) stage IIb-c, III (including in transit) and IV. Stage III CMM patients with unknown primary and stage IIb-c CMM patients who have not undergone sentinel node procedure are...
- A complete physical examination within 28 days prior to randomization
- Previous adjuvant treatment with BRAF + MEK inhibitors is allowed.
- Neoadjuvant treatment with immunotherapy for two months (currently pembrolizumab every third weeks three times or nivolumab every fourth week two times) is allowed providing that a complete or near complete pathological...
- All participants who have not received neo-adjuvant treatment must have disease-free status documented by radiological assessment within 28 days prior to randomization while 6 weeks is sufficient for neo-adjuvant...
- Participants must be off immunosuppressive doses of systemic steroids (\>10 mg/day prednisone or equivalent) for a minimum of 14 days prior to study drug administration.
- Sufficient renal function for radiological assessments with i.v. contrast.
- Peri-operative radiation therapy is allowed.
- Patients who experience a locoregional lymph node relapse, i.e. stage III disease or operable stage IV at a time-point later than primary diagnosis are welcome to participate.
- The patient is, in the opinion of the investigator, assessed as unfit to receive systemic adjuvant treatment.
- Serious and/or uncontrolled medical disorder that in the opinion of the investigator is contraindicated.
- An active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism requiring hormone replacement only and skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease and liver cirrhosis).
- Inability to provide informed consent or refusal to do so.
- Inability to comply with the study protocol.
- Participation in other clinical trials interfering with the current study protocol.
- Existing or previous malignancies within the past 5 years (except for in situ breast and in situ cervical cancer, melanoma in situ, malignant melanoma, non-melanoma skin cancer and low risk prostate cancer).
- Pregnancy or planned pregnancy.
- Ocular and mucosal melanoma.
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Kuopio, Finland
- Tampere, Finland
- Turku, Finland
- Ålesund, Norway
- Bergen, Norway
- Kristiansand, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
- Eskilstuna, Sweden
- Falun, Sweden
- Gävle, Sweden
- Gothenburg, Sweden
- Jönköping, Sweden
- Kalmar, Sweden
- Karlstad, Sweden
- Linköping, Sweden
- Lund, Sweden
+ 5 more site(s).
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 Helsinki, Finland; Kuopio, Finland; Tampere, Finland; Turku, Finland; Ålesund, Norway; Bergen, Norway and 19 more location(s). 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.