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
NCT07130032 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-08-19
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.
Conditions
- Metastatic Non-small Cell Lung Cancer (NSCLC)
- Metastatic Cutaneous Melanoma
Interventions
- COMBINATION_PRODUCT
-
reICB regimen (NSCLC)
* ICI (one of the following): Atezolizumab 1200 mg every 3 weeks/Nivolumab 240 mg every 2 weeks/Pembrolizumab 200 mg every 3 weeks * Cyclophosphamide 50 mg PO daily * Bevacizumab 7.5 mg/kg every 3 weeks
- COMBINATION_PRODUCT
-
reICB regimen (melanoma)
* ICI (one of the following): Nivolumab 240 mg every 2 weeks/Pembrolizumab 200 mg every 3 weeks * Cyclophosphamide 50 mg PO daily * Bevacizumab 7.5 mg/kg every 3 weeks
Sponsors & Collaborators
-
First Pavlov State Medical University in St. Petersburg, Russia
collaborator UNKNOWN -
EuroCityClinic LLC
lead NETWORK
Principal Investigators
-
Sergey V. Orlov, Professor · EuroCityClinic LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-14
- Primary Completion
- 2025-08-14
- Completion
- 2027-12-31
Countries
- Russia
Study Locations
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