Short versus long immunotherapy after radical surgery for high-risk malignant melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, international phase 3 study comparing a shorter (six-month) versus standard (twelve-month) course of adjuvant PD-1 immunotherapy (nivolumab or pembrolizumab) after radical surgery for stage IIb-c, III, and IV cutaneous malignant melanoma. Eligible adults with ECOG 0-1 and adequate organ function are randomized at participating centers and followed for recurrence and safety outcomes. Neoadjuvant immunotherapy is allowed in some cases if a complete pathological response was not achieved. The trial aims to determine whether the shorter regimen preserves efficacy while reducing severe toxicity, visit burden, and drug costs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of written informed consent for participation.
2. ≥ 18 years of age.
3. Performance status ECOG/WHO 0-1.
4. Adequate organ functions as per standards for immunotherapy.
5. 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 eligible.
6. A complete physical examination within 28 days prior to randomization
7. Previous adjuvant treatment with BRAF + MEK inhibitors is allowed.
8. 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 response was not achieved and patients with clear progressive disease according to the pathology report are not eligible.
9. 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 treated patients.
10. 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.
11. Sufficient renal function for radiological assessments with i.v. contrast.
12. Peri-operative radiation therapy is allowed.
13. 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.

Exclusion Criteria:

1. The patient is, in the opinion of the investigator, assessed as unfit to receive systemic adjuvant treatment.
2. Serious and/or uncontrolled medical disorder that in the opinion of the investigator is contraindicated.
3. 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 requiring systemic treatment are eligible.
4. Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease and liver cirrhosis).
5. Inability to provide informed consent or refusal to do so.
6. Inability to comply with the study protocol.
7. Participation in other clinical trials interfering with the current study protocol.
8. 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).
9. Pregnancy or planned pregnancy.
10. Ocular and mucosal melanoma.

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting
• Kuopio University Hospital
  Kuopio, Finland Recruiting
• Tampere University Hospital
  Tampere, Finland Recruiting
• Turku University Hospital
  Turku, Finland Recruiting
• Ålesund Hospital
  Ålesund, Norway Recruiting
• Haukeland University Hospital
  Bergen, Norway Recruiting

Study contacts

• Principal investigator: Gustav J Ullenhag, professor — Uppsala University Hospital
• Study coordinator: Gustav J Ullenhag, professor
• Email: Gustav.Ullenhag@IGP.uu.se
• Phone: +46-18-6110000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Early wear of a Vitamin E-infused liner in a dual-mobility hip replacement

  This study tests whether a Vitamin E-infused liner in a dual-mobility hip implant wears as little as a conventional liner over two years in adults needing hip replacement.

  Recruiting Phase 4 Uppsala University · Uppsala, Uppsala County · NCT07863557

• Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury

  A group therapy program based on EAET is tested to see if it helps adults 18-65 with acquired brain injury improve emotional well-being and daily functioning.

  Recruiting Uppsala University · Uppsala · NCT07852936

• Direct lateral vs posterolateral approach for cemented total hip replacement

  This study tests whether the surgical approach affects muscle healing and early recovery after cemented total hip replacement in people with hip OA.

  Recruiting Uppsala University · Gävle · NCT07851597

• Remote Balance in Everyday Life for young MI patients with distress

  This study tests a remote 6-session program (rBEL) to help adults under 55 who had a heart attack and feel distressed see if the program and study procedures are feasible.

  Recruiting Uppsala University · Uppsala · NCT07706816

• Home-based cardiovascular health screening for people turning 50, 55, 60, 65, 70 or 75 in Uppsala

  This trial tests whether giving people a home blood pressure monitor, a dried blood spot kit, and a questionnaire can find more cardiovascular risk factors than usual care.

  Recruiting Uppsala University · Uppsala · NCT07614659

• Thumb base arthritis: joint replacement vs trapeziectomy

  This trial tests whether a total thumb joint replacement (TOUCH prosthesis) works as well as trapeziectomy for people with basal thumb arthritis.

  Recruiting Uppsala University · Uppsala · NCT07569549

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.