Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, double-blind placebo-controlled, multicenter, randomized phase II trial testing the adjuvant immunotherapy with Nivolumab plus Ipilimumab Placebo or Nivolumab plus Ipilimumab versus Double Placebo Control as a post-surgical/post-radiation treatment for stage IV melanoma with no evidence of disease (NED).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. med. Dirk Schadendorf
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab

Criteria

Inclusion Criteria:

• Stage IV melanoma arising from a primary cutaneous site or metastatic from an unknown primary site with no evidence of disease (NED) after surgery or radiation therapy (conducted within 8 weeks before enrolment)

• Signed written informed consent

• Known BRAF status

• Subjects 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 or 1

• Tumor tissue from the resected site of disease must be provided for biomarker analyses. In order to be randomized a subject must have a PD-L 1 expression classification (positive (≥ 5% tumor cells expressing PD-L1) or negative (< 5% tumor cells expressing PD-L1)). If an insufficient amount of tumor tissue from the resected site is provided for analysis, acquisition of additional archived tumor tissue (block and/or slides) for the biomarker analyses is required.

• Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration

• Required laboratory values

• Negative pregnancy test for female subjects and effective contraception (Pearl-Index <1) for both male and female subjects if the risk of conception exists

Exclusion Criteria:

• History of primary uveal or mucosal melanoma

• Prior therapy with CTLA4 or PD1 antibodies

• The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.

• Lack of availability for clinical follow-up assessments.

• Any immunosuppressive therapy given within the past 30 days prior to study drug administration (excluding physiologic steroid hormone replacement)

• Other malignancies within the past five years requiring treatment except basal or squamous skin carcinomas or carcinoma in situ of the cervix

• Serious cardiac, gastrointestinal, hepatic or pulmonary disease reducing life expectancy to less than five years

• Patients with 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 chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.

• Known hypersensitivity reaction to any of the components of study treatment

• Pregnancy (absence to be confirmed by ß-HCG urinary test, minimum sensitivity 25IU/L or equivalent units of HCG)) or lactation period

• Women of childbearing potential (WOCBP): Refusal or inability to use effective means of contraception (Pearl-Index <1). WOCBP will be instructed to adhere to contraception until 31 weeks after the last dose of investigational product

• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (Pearl-Index <1). Men receiving Nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception until 31 weeks after the last dose of investigational product

• Known alcohol or drug abuse

• Participation in another clinical study and use of any investigational or non-registered product (drug or vaccine) within the 30 days before registration

• Significant disease or condition which, in the investigator's opinion, would exclude the patient from the study

• Legal incapacity or limited legal capacity