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

Recruiting now · Phase 2

Conditions studied: Metastatic Non-small Cell Lung Cancer (NSCLC), Metastatic Cutaneous Melanoma

In brief

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.

Key facts

Study ID: NCT07130032
Run by: EuroCityClinic LLC
People needed: 90
Starts: 2025-08-14
Expected to finish: 2027-12-01
Last updated by the study team: 2025-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

EuroCityClinic LLC — Saint Petersburg, Sankt-Peterburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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