This study will evaluate efficacy and safety of anti-PD-1/PD-L1 antibodies combined with bevacizumab and metronomic cyclophosphamide in patients with metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma previously treated with immune checkpoint blockade (ICB). The hypotheses of this study are that a combination of ICB, cyclophosphamide, and bevacizumab prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
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Age ≥ 18 years
Histologically confirmed diagnosis of NSCLC and cutaneous melanoma with distant metastases.
Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias.
Stroke and/or transient ischemic attack within 6 months prior to screening;
Uncontrolled hypertension
History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at least 2 years prior to randomization AND no additional therapy is required during the study period. Patients having hepatic involvement of cancer should be excluded as per investigator assessment.
EuroCityClinic LLC
Lead sponsor
First Pavlov State Medical University in St. Petersburg, Russia
Collaborator