Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors (TRX518-001) (NCT01239134)
- Henry Koon, M.D., University Hospitals
- Dale Shepard, M.D., Ph.D., Cleveland Clinic
- Jedd D. Wolchok, M.D., Ph.D., and Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
Results
Trials Supported with Reagents
A multi-peptide vaccine plus Toll-like receptor agonists in melanoma patients, with evaluation of the injection site microenvironment for resected stage IIB-IV
- Craig L. Slingluff Jr., M.D., University of Virginia Health System
A phase I open label, multicenter, multi-ascending dose trial evaluating the safety, tolerability, and immunogenicity of intramuscular recombinant NY-ESO-1 protein with GLA-SE adjuvant in patients with unresectable or metastatic cancer expressing NY-ESO-1
- Immune Design, Seattle, WA
A phase I study of cancer vaccine CHP-NY-ESO-1 in combination with Poly-ICLC in patients with esophageal cancer or malignant melanoma expressing NY-ESO-1
- Hiroshi Shiku, M.D., and Shinichi Kageyama, M.D., Mie University School of Medicine, Mie, Japan
A phase I study of concomitant WT1 analog peptide and NY-ESO-1
- David O’Malley, M.D., The Ohio State University Wexner Medical Center
- Paul Sabbatini, M.D., Memorial Sloan Kettering Cancer Center
A phase I study of vaccination with NY-ESO-1 protein mixed with Poly-ICLC, OK-432 (Picibanil®), and ISA-51 (Montanide®) in patients with advanced cancers expressing NY-ESO-1
- Yuichiro Doki, Ph.D., and Hisashi Wada, M.D., Ph.D., Osaka University, Japan
A phase IA/IB study of vaccination with NY-ESO-1 protein, Poly-ICLC, and mogamulizumab in patients with adult T cell leukemia/lymphoma expressing NY-ESO-1
- Yuzuru Kanakura, Ph.D., and Hiroyoshi Nishikawa, M.D., Ph.D., Osaka University, Japan
A phase II open label randomized study of Poly-ICLC-matured dendritic cells as an adjuvant for NY-ESO-1 and MELANA/MART-1 peptide vaccination compared to Montanide ISA-51 in patients with melanoma
- Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai
A pilot study of a novel multimodality immuno-chemotherapy platform for patients with advanced cutaneous T cell lymphoma
- Catherine M. Diefenbach, M.D., NYU Langone Medical Center
A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus Poly-ICLC in stage IB-IIIA breast cancer
- Patrick M. Dillon, M.D., University of Virginia Health System
A preclinical mouse vaccination experiment to compare the effectiveness of Poly-ICLC to that of the more common QS-21
- Samuel Danishefsky, Ph.D., Memorial Sloan Kettering Cancer Center
A trial to evaluate the immunogenicity and safety of a melanoma helper peptide vaccine plus novel adjuvant combinations
- Craig L. Slingluff Jr., M.D., University of Virginia Health System
Evaluation of safety and immunogenicity of a multi-phosphapeptide vaccine plus Poly-ICLC in participants with melanoma
- Victor H. Engelhard, Ph.D., and Craig L. Slingluff Jr., M.D., University of Virginia Health System
Phase I study of NY-ESO-1 protein + Poly-ICLC +/- Montanide® ISA-51 VG vaccine in patients with advanced malignant melanoma
- Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai
Phase I/II trial of a long peptide vaccine (LPV8) + Toll-like receptor agonists for resected stage IIB-IV
- Craig L. Slingluff Jr., M.D., University of Virginia Health System
Role of Toll-like receptor 3 in macrophage-mediated programmed cell removal of tumor cells
- Irving Weissman, M.D., Stanford University School of Medicine
Safety and immunogenicity of vaccination with XAGE1b long peptides combined with Poly-ICLC in patients with stage III/IV pulmonary adenocarcinoma
- Christian Taube, M.D., and Maarten L. Zandvliet, Ph.D., Leiden University Medical Center, The Netherlands
Terminated
Nivolumab Ipilimumab in Patients with HyperMutated Cancers Detected in BLood (NIMBLe) (NCT03461952)
Early termination due to low enrollment
- Naiyer Rizvi, M.D., Ph.D., Herbert Irving Comprehensive Cancer Center, Columbia University
- Stephen Chia, M.D., British Columbia Cancer Agency, Canada
- Holger Hirte, M.D., Juravinski Cancer Center, Canada
- Patricia Tang, M.D., Tom Baker Cancer Center, Canada
- Michael Vickers, M.D., MPH, The Ottawa Hospital, Canada
Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer (NCT02898116)
Early termination due to the rapidly changing treatment landscape for ALK-positive NSCLC, resulting in low enrollment
- Leena Gandhi, M.D., Ph.D., NYU Langone's Perlmutter Cancer Center
Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant (NCT02716805)
FDA placed on partial hold due to additional data
- Alexander M. Lesokhin, M.D., Memorial Sloan Kettering Cancer Center