Advanced Melanoma Clinical Trial
Official title:
Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study
The aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can induce a measurable immune response in patients with metastatic malignant melanoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.
Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived
mature dendritic cells with a fixed interval. The dendritic cells are generated from
leukapheresis products and frozen after antigen loading.
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and
telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed
DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106
peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week
intervals. Those patients who exhibit stable disease, partial response or complete response
after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is
applied by intradermal injection near the inguinal region.
IL-2 2 MIU s.c. day 2-6, Cyclophosphamide (Sendoxan®, Baxter A/S) 50 mg twice a day
bi-weekly and 200 mg Celecoxib (Celebra®, Pfizer) daily are used. Scans and re-staging tests
are performed at scheduled intervals throughout the study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05039801 -
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04894994 -
FLX475 in Combination With Ipilimumab in Advanced Melanoma
|
Phase 2 | |
| Completed |
NCT01621490 -
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
|
Phase 1 | |
| Recruiting |
NCT05098184 -
Study on TIL for the Treatment of Advanced Melanoma
|
Early Phase 1 | |
| Completed |
NCT02177110 -
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
|
||
| Completed |
NCT04165967 -
Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma
|
Phase 1 | |
| Active, not recruiting |
NCT04495257 -
A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)
|
Phase 1 | |
| Recruiting |
NCT05968690 -
Naltrexone and Propranolol Combined With Immunotherapy
|
Phase 1 | |
| Active, not recruiting |
NCT03200847 -
Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05105100 -
Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma
|
||
| Completed |
NCT02171286 -
The Oncopanel Pilot (TOP) Study
|
N/A | |
| Terminated |
NCT01453361 -
Phase II FANG™ in Advanced Melanoma
|
Phase 2 | |
| Recruiting |
NCT05120024 -
Multicenter Study of Safety and Efficacy of Prolgolimab in Patients With Advanced Melanoma in Routine Clinical Practice
|
||
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Active, not recruiting |
NCT04951583 -
Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma
|
Phase 2 | |
| Recruiting |
NCT06112808 -
A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
|
Phase 1 | |
| Recruiting |
NCT01614301 -
Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04640545 -
A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma
|
Phase 1 | |
| Active, not recruiting |
NCT03086174 -
Tolerability and Pharmacokinetics of Toripalimab in Combination With Axitinib in Patients With Kidney Cancer and Melanoma
|
Phase 1 | |
| Recruiting |
NCT03917069 -
Nab-PCE vs PC for MM After Failure of Anti-PD-1
|
Phase 2 |