scholarly journals Dendritic cell-based vaccination in metastatic melanoma patients: Phase II clinical trial

2012 ◽  
Vol 28 (4) ◽  
pp. 1131-1138 ◽  
Author(s):  
CHIE OSHITA ◽  
MASAKO TAKIKAWA ◽  
AKIKO KUME ◽  
HARUO MIYATA ◽  
TADASHI ASHIZAWA ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dendritic Cell ◽  
Metastatic Melanoma ◽  
Phase Ii ◽  
Phase Ii Clinical Trial ◽  
Melanoma Patients

Clinical and Immunological responses in patients with malignant melanoma treated with a dendritic cell-based vaccine. Preliminary report from a multi-institutional phase II clinical trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 3004-3004
Author(s):  
M. Ross ◽  
L. H. Camacho ◽  
E. M. Hersh ◽  
C. K. Brown ◽  
J. Richards ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Immune Response ◽  
T Cells ◽  
Metastatic Melanoma ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Therapeutic Vaccine ◽  
Phase Ii Clinical Trial ◽  
Age Related Macular Degeneration ◽  
Ifn Γ

3004 Background: We have previously reported that vaccination with IDM therapeutic vaccine (IDD-3/Uvidem [Uvidem is co-developed with SANOFI-AVENTIS]) composed of dendritic cells (DC) loaded with three allogeneic lysates from tumor cell lines can elicit immune and anti-tumor responses. We describe here the preliminary results from a phase II clinical trial in metastatic melanoma patients. Methods: DC-MEL-202 is a single arm, two-stage phase II trial designed to evaluate clinical and immunological activities and the safety of a multivalent DC vaccine in patients with in-transit or low volume metastatic melanoma. There was no HLA restriction. Autologous DC were generated, under GMP conditions, from monocytes cultured in GM-CSF and IL-13, loaded with three allogeneic melanoma tumor lysates (M44, SK-MEL 28 and COLO 829) and matured with a combination of bacterial extract (FMKP) and IFN-γ, generating up to 15 doses of the vaccine containing 25x106 DC. Patients received six bi-weekly and two 6-weekly injections (id and sc). Clinical responders were eligible to receive additional doses. Immune response against tumor-associated antigens (TAA) peptides was assessed, at several time points, by detection of IFN-γ producing cells by flow cytometry Results: 33 patients were treated. To date: Vaccination is well tolerated with toxicity limited to mild events (only one possibly related SAE, age-related macular degeneration, was reported). Clinical response (RECIST): 6 patients showed evidence of clinical benefit (1CR, 1PR and 4 SD) with duration of response ranging from 7.5 to 22 months. Assessment of pathological response in target sites in 2 pts (1 PR, 1 SD) showed no residual disease.. 23/33 patients are still alive with a mean follow-up of 11mo (range 3–22mo). Mature data of PFS and OS will be presented. Immune response: 21 (84 %) out of 25 evaluated patients showed detectable TAA-specific CD8+ T cells with ten showing boosted or appearance of anti-TAA specific CD8+ T cells. Conclusions: Vaccination with IDD-3/Uvidem is safe and can elicit tumor specific CD8+ T cells not limited to HLA-A2+ patients. Substantial clinical benefit warrants further development of IDD3. No significant financial relationships to disclose.

Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a phase II clinical trial

2020 ◽  
Author(s):  
Firas S. Ahmed ◽  
Laurent Dercle ◽  
Gregory V. Goldmacher ◽  
Hao Yang ◽  
Dana Connors ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Advanced Melanoma ◽  
Phase Ii Clinical Trial ◽  
Recist 1.1 ◽  
Melanoma Patients

Phase II clinical trial with a second generation, GM-CSF encoding, oncolytic herpesvirus in unresectable metastatic melanoma

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 9008-9008 ◽  
Author(s):  
N. N. Senzer ◽  
H. L. Kaufman ◽  
T. Amatruda ◽  
M. Nemunaitis ◽  
T. R. Reid ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Metastatic Melanoma ◽  
Phase Ii ◽  
Second Generation ◽  
Phase Ii Clinical Trial ◽  
Gm Csf
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