Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVestre Viken Hospital Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed NSCLC stage IIIB/IIIC or IV not amenable for curative treatment, with PD-L1 ≥ 50% measured by a validated method, and eligible for pembrolizumab monotherapy in the first-line setting
At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline according to RECIST 1.1
Subjects who received previous neo-adjuvant or adjuvant systemic therapy (other than immunotherapies) will be eligible if neo-adjuvant or adjuvant therapy was completed at least 12 months prior to the development of metastatic disease. Last dose of neoadjuvant or adjuvant therapy must be more than 12 months prior to enrollment/randomization
Available unstained archived tumour tissue sample in sufficient quantity to allow for analyses. At least fifteen unstained slides or a tumour block (preferred)
Disqualifiers
Previous treatment with a PD-1 or PD-L1 inhibitor, including pembrolizumab or any other agent targeting immune checkpoints
Previous malignancy (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry
Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids (prednisone >10 mg or equivalent). Surgery, radiation and/or corticosteroids (any dose >10 mg prednisone equivalent) must have been completed ≥ 2 weeks prior to registration
Known history of leptomeningeal carcinomatosis
Trial design
Design model
Parallel
Treatments tested in this trial
UV1
Biological/VaccineUV1 vaccine
Sagramostim
Drugfor stimulation of local dendritic cell population to take up the vaccine and to mature into professional APCs
Anti-PD-1/PD-L1 treatment
Drugeither pembrolizumab, atezolizumab or cemiplimab
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: anti-PD-1/PD-L1 treatment + UV1 vaccinationExperimental treatment 3 interventions
Group B: anti-PD-1/PD-L1 treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) as determined by Blinded Independent Central Review (BICR)
Evaluate and compare the efficacy of anti-PD-1/PD-L1-treatment with or without UV1 vaccination in patients with stage IIIB/IIIC or stage IV NSCLC.
Time frame
Up to 2 yearsSecondary outcomes
1
Response evaluation
Comparison of response rate according to RECIST v1.1 in patients who receive anti-PD-1/PD-L1 treatment and patients who receive anti-PD-1/PD-L1 treatment in combination with UV1.
Time frame
Throughout trial (up to 2 years)2
monitoring AE
evaluate safety and tolerability in patients who receive anti-PD-1/PD-L1 treatment and patients who receive anti-PD-1/PD-L1 treatment in combination with UV1.
Time frame
continously and until 4 months after discontinuation of study treatmentOther outcomes
1
molecular characterization and analyses
investigate for possible biological markers for response, resistance and toxicity
Time frame
up to 2 years2
immunophenotyping or characterization of the immune cell subsets in the periphery
Investigate immunological responses.
Time frame
In biological samples collected at screening, visit 5/6, end-of-treatment, safety visit and first follow-up visit.3
To investigate the role of PET/CT in early response evaluation
PET-CT will be taken at predefined time-points for a subset of patients
Time frame
up to 2 yearsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Vestre Viken Health TrustRecruiting3004, Drammen, Akershus
Norway
NorwaySponsors and contacts
Click on the lead sponsor to view all of their trials.
Vestre Viken Hospital Trust
Lead sponsor
University Hospital, Akershus
Collaborator
Oslo University Hospital
Collaborator
Haukeland University Hospital
Collaborator
Helse Stavanger HF
Collaborator
Helse Fonna
Collaborator
Helse Nord-Trøndelag HF
Collaborator
St. Olavs Hospital
Collaborator
Alesund Hospital
Collaborator
Helse Forde
Collaborator
University Hospital of North Norway
Collaborator
Source ClinicalTrials.gov