Actively Recruiting
Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer
Led by Vestre Viken Hospital Trust · Updated on 2023-11-09
138
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
V
Vestre Viken Hospital Trust
Lead Sponsor
U
University Hospital, Akershus
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Randomized, Multicenter Study Investigating Efficacy and Safety of anti-PD-1/PD-L1-treatment +/- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer. The objective of the phase 2 study is to induce a meaningful Progression-Free Survival (PFS) benefit in patients with stage IIIB/IIIC or stage IV NSCLC by treating with anti-PD-1/PD-L1 treatment and UV1 vaccination versus anti-PD-1/PD-L1 treatment alone.
CONDITIONS
Official Title
Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IIIB, IIIC, or IV NSCLC not suitable for curative treatment with PD-L1 60; 50% and eligible for pembrolizumab monotherapy as first-line treatment
- At least one measurable tumor lesion not previously irradiated or biopsied during screening
- Previous neo-adjuvant or adjuvant systemic therapy allowed if completed more than 12 months before metastatic disease
- Available archived tumor tissue samples sufficient for analysis (at least fifteen unstained slides or tumor block)
- Male or female aged 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function including hemoglobin 60; 9.0 g/dL, absolute neutrophil count 60; 1.5 x 10^9/L, platelet count 60; 100 x 10^9/L
- Serum bilirubin 60; 1.5 times institutional upper limit of normal (ULN)
- AST/ALT 60; 2.5 times ULN or 60; 5 times ULN if liver metastases present
- Creatinine clearance greater than 40 mL/min (measured or calculated)
- Written informed consent obtained before any study procedures
You will not qualify if you...
- Previous treatment with PD-1 or PD-L1 inhibitors including pembrolizumab or similar agents
- Prior malignancy except certain non-melanoma skin cancers and specific in situ cancers unless remission achieved for at least 2 years
- Symptomatic or uncontrolled brain metastases requiring recent treatment or corticosteroids over 10 mg prednisone equivalent
- Known leptomeningeal carcinomatosis or uncontrolled seizures
- Use of immunosuppressive medications within 28 days before pembrolizumab dosing except low-dose corticosteroids
- Active or recent autoimmune or inflammatory disorders within 2 years, except some stable conditions
- History of primary immunodeficiency or allogeneic organ transplant
- Uncontrolled infections including active tuberculosis, hepatitis B or C, or HIV infection
- Pregnant or breastfeeding women
- Live attenuated vaccines within 30 days before or after starting pembrolizumab
- Conditions interfering with study evaluation or safety assessment
- Allergy or hypersensitivity to study drugs or excipients
- Involvement in study planning or conduct
- Expected non-compliance with study procedures or inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vestre Viken Health Trust
Drammen, Akershus, Norway, 3004
Actively Recruiting
Research Team
O
Odd Terje Brustugun, Md, PhD
CONTACT
I
Inger Johanne Zwicky Eide, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
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