Melanoma Clinical Trial
Official title:
Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
This is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/Hodgkin's lymphoma/Non-small cell lung cancer). The primary objective is to compare serotype specific immunoglobulin G (IgG) antibody titres before and after pneumococcal vaccination in patients receiving Immune Checkpoint Inhibitors (ICI). As an explorative objective, serotype specific IgG antibodies measured by ELISA and those measured by Opsonophagocytosis assay (OPA) after pneumococcal vaccination in patients receiving ICI will be correlated. In addition, the incidence of immune related adverse events (irAE) in patients vaccinated during ICI treatment will be determined.
Physicians will be informed by mail and pocket cards with all necessary information about the study, in particular eligibility criteria. Patients currently receiving Immune Checkpoint Inhibitors will be approached by their treating physicians in case of an already scheduled vaccination against S. pneumonia. If a patient agrees to participate in the study and to sign an informed consent form, basic data on demographics, underlying disease, comorbidities, and irAE will be obtained from the electronic health record and entered into the eCRF. Pneumococcal antibody titers will be drawn at baseline and after 30 days. We will actively follow-up on study patients for four months after enrolment and screen health records of the enrolled patients after four months to record occurrence of irAE. A blood sample (9 ml) will be drawn before vaccination. Vaccination will either be performed by the treating physician or by a general practitioner. After 30 days, a second blood sample will be taken during an already planned visit at the (outpatient) clinic. Titer assessment will be performed along STIKO recommendations for immunocompromised patients. All samples for ELISA and OPA titer determination will be stored frozen at Department I for Internal Medicine and titers will be analyzed in batch at the end of this study. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (RKI STIKO recommendations). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT03979872 -
Risk Information and Skin-cancer Education for Undergraduate Prevention
|
N/A | |
| Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
| Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
| Recruiting |
NCT05077137 -
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
|
Phase 1 | |
| Active, not recruiting |
NCT02721459 -
XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma
|
Phase 1 | |
| Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Recruiting |
NCT05839912 -
Excision of Lymph Node Trial (EXCILYNT) (Mel69)
|
N/A | |
| Recruiting |
NCT04971499 -
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05263453 -
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
|
Phase 2 | |
| Not yet recruiting |
NCT06413680 -
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT03348891 -
TNF in Melanoma Patients Treated With Immunotherapy
|
N/A | |
| Terminated |
NCT03399448 -
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
|
Phase 1 | |
| Completed |
NCT03171064 -
Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
|
Phase 2 | |
| Not yet recruiting |
NCT05539118 -
Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05171374 -
pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
|
||
| Withdrawn |
NCT02854488 -
Yervoy Pregnancy Surveillance Study
|