NCT07130032 Efficacy And Safety Of Anti-PD-1/PD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 90 participants in total. It began in 2025-08-14 with a primary completion date of 2025-08-14.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Provide written informed consent * Age ≥ 18 years * Histologically confirmed diagnosis of NSCLC and cutaneous melanoma with distant metastases. * No mutations in the EGFR gene, ALK, ROS1, RET gene translocations (in case of NSCLC). * For NSCLC: the individuals had previously received anti-PD-(L)1 antibodies in combination with platinum-containing chemotherapy either in the first line or sequentially in the first and second lines for the treatment of metastatic disease. * For NSCLC: the individuals had previously received anti-PD-(L)1 antibodies for \>6 months and experienced disease progression. * For cutaneous melanoma: the individuals had previously received anti-PD-1 antibodies either in combination with or without anti-CTLA4 therapy for metastatic disease. If the patient had the BRAF V600 mutation, they were also treated with BRAF and MEK inhibitors. * For cutaneous melanoma: the patient has previously received anti-PD-1 antibodies with or without anti-CTLA4 therapy for metastatic disease for \>6 months and experienced disease progression Exclusion Criteria: * 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. * Patients with CNS metastases are eligible only if the metastases are adequately treated. * Absolute neutrophil count (ANC) \<1.5×109/L, platelet count \<100×109/L, or hemoglobin \<9.0 g/dL. * Serum total bilirubin \>1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin \<2 X ULN, and normal AST/ALT are eligible; * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × ULN; * Serum creatinine \>1.5 × ULN. * History of a thromboembolic event * Presence of any allergic reactions to components of the study drugs * Concomitant medications with a known risk of causing QT prolongation and/or Torsades de Pointes. * Any parallel anti-cancer systemic therapy, radiation therapy * Women who are pregnant or lactating; * Presence of unresolved adverse events of grade 2 or higher toxicity, according to CTCAE v5.0 criteria, from prior therapy (except for alopecia or neurotoxicity grade≤2). * Any other serious or uncontrolled medical disorder, active infection, physical examination finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a patient's ability to comply with the study requirements, substantially increase risk to the patient, or impact the interpretability of study results.

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