Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma

Conditions

• Malignant Melanoma Stage II

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  480 mg nivolumab fixed dose given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year

Study Details

Stage II patients with primary surgical treatment of cuMM are often at risk for recurrence of their disease. This risk may be reduced by adjuvant systemic treatment. Due to toxicities of adjuvant therapies the aim is to identify patients at high risk for relapse and to administer adjuvant treatment only to these patients. Thus an optimal balance between insufficient treatment vs. overtreatment has to be found. To define these patients a prognostic biomarker test will be used in addition to conventional AJCC staging. AJCC staging takes into account several prognostic factors. However, to subdivide stage II melanoma patients into having a low or high risk for relapse further methods are needed. This clinical trial will evaluate whether adjuvant nivolumab treatment will improve relapse-free survival (RFS) in patients with stage II high-risk melanoma as compared to observation only. The randomized approach of this trial offers the most objective method with the least influence of bias. Since patients with stage II melanoma are usually not receiving adjuvant treatment, no patient will be undertreated in case of randomization into observational arm.

Key Dates

Start date

Jul 1, 2020

Status verified

May 2024

Primary completion

Sep 30, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

374 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab (Arm A)
  Patients with a risk score of \> 0.0 corresponding to high risk of relapse (randomized): Nivolumab will be applied at a flat dose of 480 mg given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year. Afterwards these patients will receive intense clinical follow up according German Follow up guidelines.
• No Intervention: Observation, High Risk (Arm B)
  Patients with a risk score of \> 0.0 corresponding to high risk of relapse (randomized): Control group (observation only). These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines.
• No Intervention: Observation, Low Risk (Arm C)
  Patients with a risk score of ≤ 0.0 corresponding to low risk of relapse who are not eligible for randomization: These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines. Documentation of clinical outcome of these patients.

Primary Outcome Measure

Relapse-Free Survival (RFS) rates [ Time Frame: 5 years ]