Oncology Clinical Trial
Official title:
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
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.
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. Patients are randomized to receive anti-PD-1/PD-L1 treatment until progression or unacceptable toxicity, for a maximum of 2 years, with or without 8 injections of 300 μg UV1 and 75 μg GM-CSF (UV1 vaccination). Patients randomized to UV1 vaccination, will start UV1 vaccination the same day as anti-PD-1/PD-L1 treatment is initiated, followed by three vaccinations over the next ten days. Thereafter, one vaccination per anti-PD-1/PD-L1 treatment cycle (c2-5), totaling to 8 UV1 vaccinations ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01439152 -
Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
| Active, not recruiting |
NCT06015009 -
Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers
|
N/A | |
| Active, not recruiting |
NCT03298100 -
Risk Scoring Model for Endometrial Cancer
|
||
| Recruiting |
NCT05055609 -
Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT04324320 -
Psychological Distress in Outpatient Oncological Rehabilitation
|
||
| Completed |
NCT00588289 -
Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA
|
N/A | |
| Recruiting |
NCT06222801 -
The 1st Tumor CytokinoTherapy Database (TCTD-1)
|
||
| Recruiting |
NCT03831633 -
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
|
Phase 4 | |
| Completed |
NCT04914702 -
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
|
||
| Recruiting |
NCT05198570 -
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
|
||
| Recruiting |
NCT05712174 -
A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT03832062 -
Value of Analysing Under-utilised Leftover Tissue (VauLT)
|
||
| Completed |
NCT03988777 -
Magnetic Seed Localisation for Nonpalpable Breast Lesions
|
||
| Recruiting |
NCT06031233 -
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
|
Phase 4 | |
| Enrolling by invitation |
NCT04019119 -
Digital Intervention for the Modification of Lifestyles (iGame)
|
N/A | |
| Not yet recruiting |
NCT05926362 -
Capillary-Venous Paired Data Collection
|
||
| Recruiting |
NCT05686213 -
ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial
|
Phase 2 | |
| Recruiting |
NCT05510856 -
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
|
Phase 4 | |
| Completed |
NCT04180306 -
PEWS Implementation in an LMIC Setting
|
N/A |