Actively Recruiting
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
Led by EuroCityClinic LLC · Updated on 2025-08-19
90
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
Sponsors
E
EuroCityClinic LLC
Lead Sponsor
F
First Pavlov State Medical University in St. Petersburg, Russia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Provide written informed consent
- Age 18 years or older
- Histologically confirmed diagnosis of NSCLC or cutaneous melanoma with distant metastases
- No mutations in EGFR gene, ALK, ROS1, RET gene translocations (for NSCLC patients)
- For NSCLC: prior treatment with anti-PD-(L)1 antibodies plus platinum chemotherapy in first or second line
- For NSCLC: prior anti-PD-(L)1 antibody treatment for more than 6 months with disease progression
- For cutaneous melanoma: prior anti-PD-1 antibody treatment with or without anti-CTLA4 therapy for metastatic disease
- For cutaneous melanoma with BRAF V600 mutation: prior treatment with BRAF and MEK inhibitors
- For cutaneous melanoma: prior anti-PD-1 antibody treatment for more than 6 months with disease progression
You will not qualify if you...
- Clinically significant cardiovascular disease including severe or unstable ischemic heart disease, myocardial infarction history, congestive heart failure (NYHA Class III/IV), ventricular arrhythmias
- Stroke or transient ischemic attack within 6 months before screening
- Uncontrolled high blood pressure
- History of other cancers except non-melanoma skin cancers or in situ cervical/breast cancer unless in complete remission for at least 2 years and no therapy needed
- Patients with liver involvement of cancer as assessed by investigator
- Patients with CNS metastases only if adequately treated
- Low blood counts: absolute neutrophil count below 1.5 x 10^9/L, platelet count below 100 x 10^9/L, or hemoglobin below 9.0 g/dL
- Elevated bilirubin above 1.5 times upper limit normal except Gilbert syndrome cases with normal liver enzymes
- Elevated liver enzymes (ALT or AST) above 3 times upper limit normal
- Elevated serum creatinine above 1.5 times upper limit normal
- History of blood clots
- Allergic reactions to study drug components
- Use of medications known to cause QT prolongation or Torsades de Pointes
- Concurrent anti-cancer systemic therapy or radiation therapy
- Pregnant or lactating women
- Unresolved grade 2 or higher adverse events from prior therapies except alopecia or mild neurotoxicity
- Any other serious or uncontrolled medical condition, active infection, altered mental status, or psychiatric condition limiting study compliance or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
EuroCityClinic LLC
Saint Petersburg, Sankt-Peterburg, Russia, 197022
Actively Recruiting
Research Team
S
Sergey V. Orlov, Professor
CONTACT
A
Aram A. Musaelyan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here