Universidad Peruana Cayetano Heredia
A Phase I-II multicenter trial with Avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients; GEMCAD 1602 study
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| dc.contributor.author | Espanol-Rego, Marta | |
| dc.contributor.author | Fernandez-Martos, Carlos | |
| dc.contributor.author | Elez, Elena | |
| dc.contributor.author | Foguet, Carles | |
| dc.contributor.author | Pedrosa, Leire | |
| dc.contributor.author | Rodriguez, Nuria | |
| dc.contributor.author | Ruiz-Casado, Ana | |
| dc.contributor.author | Pineda, Estela | |
| dc.contributor.author | Cid, Joan | |
| dc.contributor.author | Cabezon, Raquel | |
| dc.contributor.author | Oliveres, Helena | |
| dc.contributor.author | Lozano, Miquel | |
| dc.contributor.author | Gines, Angels | |
| dc.contributor.author | Garcia-Criado, Angeles | |
| dc.contributor.author | Ayuso, Juan Ramon | |
| dc.contributor.author | Pages, Mario | |
| dc.contributor.author | Cuatrecasas, Miriam | |
| dc.contributor.author | Torres, Ferran | |
| dc.contributor.author | Thomson Okatsu, Timothy M. | |
| dc.contributor.author | Cascante, Marta | |
| dc.contributor.author | Benitez-Ribas, Daniel | |
| dc.contributor.author | Maurel, Joan | |
| dc.date.accessioned | 2022-10-12T18:25:57Z | |
| dc.date.available | 2022-10-12T18:25:57Z | |
| dc.date.issued | 2022 | |
| dc.identifier.uri | https://hdl.handle.net/20.500.12866/12367 | |
| dc.description.abstract | Background: Immune check-point blockade (ICB) has shown clinical benefit in mismatch repair-deficient/microsatellite instability high metastatic colorectal cancer (mCRC) but not in mismatch repair-proficient/microsatellite stable patients. Cancer vaccines with autologous dendritic cells (ADC) could be a complementary therapeutic approach to ICB as this combination has the potential to achieve synergistic effects. Methods: This was a Phase I/II multicentric study with translational sub-studies, to evaluate the safety, pharmacodynamics and anti-tumor effects of Avelumab plus ADC vaccine in heavily pre-treated MSS mCRC patients. Primary objective was to determine the maximum tolerated dose and the efficacy of the combination. The primary end-point was 40% progression-free survival at 6 months with a 2 Simon Stage. Results: A total of 28 patients were screened and 19 pts were included. Combined therapy was safe and well tolerated. An interim analysis (Simon design first-stage) recommended early termination because only 2/19 (11%) patients were disease free at 6 months. Median PFS was 3.1 months [2.1–5.3 months] and overall survival was 12.2 months [3.2–23.2 months]. Stimulation of immune system was observed in vitro but not clinically. The evaluation of basal RNA-seq noted significant changes between pre and post-therapy liver biopsies related to lipid metabolism and transport, inflammation and oxidative stress pathways. Conclusions: The combination of Avelumab plus ADC vaccine is safe and well tolerated but exhibited modest clinical activity. Our study describes, for the first-time, a de novo post-therapy metabolic rewiring, that could represent novel immunotherapy-induced tumor vulnerabilities. | en_US |
| dc.language.iso | eng | |
| dc.publisher | Springer | |
| dc.relation.ispartofseries | Cancer Immunology, Immunotherapy | |
| dc.rights | info:eu-repo/semantics/restrictedAccess | |
| dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es | |
| dc.subject | Vaccines | en_US |
| dc.subject | Metabolism | en_US |
| dc.subject | Resistance | en_US |
| dc.title | A Phase I-II multicenter trial with Avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients; GEMCAD 1602 study | en_US |
| dc.type | info:eu-repo/semantics/article | |
| dc.identifier.doi | https://doi.org/10.1007/s00262-022-03283-5 | |
| dc.subject.ocde | https://purl.org/pe-repo/ocde/ford#3.02.21 | |
| dc.subject.ocde | https://purl.org/pe-repo/ocde/ford#3.01.03 | |
| dc.relation.issn | 1432-0851 |
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