Malignant melanoma MedDRA version: 21.1 Level: PT Classification code 10025650 Term: Malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo 10mg/ml
Product Name: Nivolumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Nivolumab
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558
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Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Patients with histologically confirmed malignant melanoma - Age > 18 years - Written consent of the participant after being informed - Contraception as described in protocol appendix section VI b) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): PS 0 to 1. c) Previously treated, unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status. d) Patients must have experienced disease progression or recurrence during treatment with an anti-PD-1 monoclonal antibody. Progression on/after at least one line of therapy for advanced or metastatic disease, whereby prior lines of therapy are not limited to systemic therapies. Also progression within 6 months completing adjuvant therapy. (BRAF/MEK inhibitors, MEK inhibitors, ipilimumab, nivolumab, ipilimumab+ nivolumab, pembrolizumab and T-Vec are allowed as prior therapies). Treatment with investigational drugs have to be terminated at least 28 days before start of the study treatment. e) Patients with CNS metastases: - Patients are eligible if CNS metastases are treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks Prior to enrolment. In addition, patients must be either off corticosteroids or on a stable or decreasing dose =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: a) Active brain metastases or leptomeningeal metastases. Participants with brain metastases are eligible if these have been treated and there is no MRI evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study treatment administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study treatment administration. Stable dose of anticonvulsants is allowed. Treatment for CNS metastases may include stereotactic radiosurgery (e.g. GammaKnife, CyberKnife, or equivalent) or neurosurgical resection. Patients who received whole brain radiation therapy are not eligible. b) Prior treatment with interferon (adjuvant setting), IL-2 (Interleukin-2) are not allowed. c) Uveal melanoma is excluded. d) Coexisting severe chronic diseases other than melanoma (other neoplasias, autoimmune diseases,…). e) Secondary gastrointestinal motility disorders. f) Pregnancy and breast feeding. g) Large abdominal surgery in medical history. h) Intake of any medication introduced by another clinical study. i) Any conditions (e.g. allergies), that do not allow the administration or intake of any of the substances used in this study (Nivolumab, Vancomycin, colonic lavage fluid).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival (PFS) 3 months after checkpoint inhibitor (CI) therapy following FMT with feces of former CI therapy responders (>1a remission) compared to controls.;Secondary Objective: Tumor response (CR, PR, SD) after FMT in patients with malignant melanoma unresponsive to immunotherapy compared to controls. Detection of specific donor signaling in intestinal microbiota leading to response to CI therapy. Detection of specific patients’ microbiota pre and post FMT leading to response. Safety and toxicity of CI therapy after FMT vs. control group. Serum NLR pre- and post-FMT as an indicator for response.;Primary end point(s): PFS according to iRECIST criteria;Timepoint(s) of evaluation of this end point: 12 weeks after FMT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumor response (CR, PR, SD) after FMT;Timepoint(s) of evaluation of this end point: 12 weeks after FMT | — |
Countries
Austria
Contacts
Public ContactLukas Binder
Medical University of Graz
Outcome results
None listed