Actively Recruiting
A Randomized Phase II, Open-label, Multicenter Study Investigating Efficacy and Safety of Pembrolizumab +/- UV1 Vaccination as First Line Treatment in Patients With Inoperable Advanced or Metastatic Non-small Cell Lung Cancer
Led by Vestre Viken Hospital Trust · Updated on 2023-11-09
138
Participants Needed
1
Research Sites
104 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
Researchers are investigating the safety and effectiveness of combining anti-PD-1/PD-L1 treatment with UV1 vaccination compared to anti-PD-1/PD-L1 treatment alone in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who cannot have surgery. The phase 2 trial aims to improve progression-free survival in patients with stage IIIB/IIIC or IV NSCLC by using these treatments. The study evaluates whether adding UV1 vaccination can provide additional benefit alongside standard anti-PD-1/PD-L1 therapies. Participants are randomly assigned to receive either anti-PD-1/PD-L1 treatment alone or combined with UV1 vaccination and sagramostim. The anti-PD-1/PD-L1 treatment continues until disease progression or unacceptable side effects, up to two years. Patients in the UV1 vaccination group receive eight total injections: the first dose on the same day as starting anti-PD-1/PD-L1 treatment, three more within the next ten days, and one vaccination during treatment cycles two through five. During the study, participants undergo regular evaluations including imaging scans to measure tumor response according to RECIST 1.1 criteria. Researchers monitor progression-free survival over up to two years. Safety is continuously assessed and adverse events are tracked during treatment and for four months afterward. The study involves blood tests, tumor tissue analysis, and performance status assessments to evaluate organ function and overall health throughout participation.
CONDITIONS
Brief 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 NSCLC stage IIIB/IIIC or IV not suitable for curative treatment with PD-L1 60 50% by validated method
- Eligible for pembrolizumab monotherapy in first-line setting
- At least one measurable lesion not previously irradiated or biopsied
- Previous neo-adjuvant or adjuvant systemic therapy allowed if completed >12 months before metastatic disease
- Available sufficient unstained archived tumor tissue sample
- Male or female age 60 18 years at consent
- ECOG performance status of 0-2
- Adequate organ function including hemoglobin 60 9.0 g/dL, ANC >1500/mm3, platelet count 60 100 x 10^9/L
- Serum bilirubin 60 1.5 x ULN, AST/ALT 60 2.5 x ULN (or 60 5 x ULN if liver metastases present)
- Creatinine clearance >40 mL/min by calculation or 24-hour urine
- Written informed consent obtained prior to study procedures
You will not qualify if you...
- Previous treatment with PD-1 or PD-L1 inhibitors including pembrolizumab
- Previous malignancy except certain in situ cancers or non-melanoma skin cancer unless remission >2 years
- Symptomatic or uncontrolled brain metastases requiring treatment; treatment completed <2 weeks prior
- Known leptomeningeal carcinomatosis
- Uncontrolled seizures
- Use of immunosuppressive medication within 28 days before first pembrolizumab dose except low-dose corticosteroids
- Active or recent autoimmune or inflammatory disorders within 2 years (some exceptions apply)
- History of primary immunodeficiency or allogeneic organ transplant
- Uncontrolled intercurrent illness including active infection, heart failure, unstable angina, arrhythmia, peptic ulcer, bleeding disorders, or psychiatric illness limiting compliance
- Active infections including tuberculosis, hepatitis B (unless resolved), hepatitis C (if PCR negative), or HIV
- Pregnant or lactating women
- Live attenuated vaccination within 30 days before or after starting pembrolizumab
- Allergy or hypersensitivity to study drugs or excipients
- Involvement in study planning or conduct
- Investigator judgment of inability to comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants receive anti-PD-1/PD-L1 treatment with or without UV1 vaccination. UV1 vaccination includes 8 injections starting the same day as anti-PD-1/PD-L1 treatment, followed by three more vaccinations over 10 days, then one vaccination per treatment cycle for cycles 2 to 5. Anti-PD-1/PD-L1 treatment continues until disease progression or unacceptable toxicity, for up to 2 years.
Visits occur with each treatment cycle; vaccination injections occur according to the schedule described
Duration - Up to 4 months after treatment ends
Participants are monitored for adverse events continuously during treatment and for up to 4 months after discontinuation of study treatment.
Regular visits for monitoring adverse events
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
I
Inger Johanne Zwicky Eide, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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