Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medical University of Graz
With
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 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
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): PS 0 to 1.
3. 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.
4. Patients must have experienced disease progression or recurrence during treatment with an anti-PD-1 monoclonal antibody, not having OR not willing to accept other approved systemic treatment options (like: BRAF and MEK inhibitors in BRAF V600 mutated melanoma).
5. Patients with CNS (central nervous system) metastases:
6. Patients must have evaluable disease by CT (computer tomography) or MRI (magnet resonance imaging) per RECIST 1.1 criteria (Appendix 3) (radiographic tumor assessment performed before as well as after 10 weeks of first dose of study drug) or clinically apparent disease that the investigator can follow for response.
2. Prior treatment with chemotherapy, interferon (adjuvant setting), IL-2 (Interleukin-2), BRAF/MEK Inhibitors (v-Raf murine sarcoma viral oncogene homolog B/Mitogen-Activated Protein Kinase) for subjects with known BRAF V600 mutations, MEK inhibitors for NRAS (N-Rat sarcoma) mutations, and cKIT (Tyrosinkinase) Inhibitor subjects with known cKIT mutations is NOT allowed.
3. Uveal melanoma is excluded.
4. Coexisting severe chronic diseases other than melanoma (other neoplasias, autoimmune diseases,…).
5. Secondary gastrointestinal motility disorders.
6. Pregnancy and breast feeding.
7. Large abdominal surgery in medical history.
8. Intake of any medication introduced by another clinical study.
9. 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).
