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 Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients (MEL58) (NCT01585350)
- Craig L. Slingluff Jr., M.D., University of Virginia Health System
A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer (NCT02015416)
- Immune Design, Seattle, WA
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers (NCT00291473)
- 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 Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence (NCT02334735)
- Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai
Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41) (NCT01532960)
- 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
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma (Mel63; CHAMP) (NCT02425306)
- Craig L. Slingluff Jr., M.D., University of Virginia Health System
Results
Evaluation of a Multi-phosphopeptide Vaccine Plus PolyICLC in Participants With High Risk and Advanced Malignancies (Mel59) (NCT01846143)
- Victor H. Engelhard, Ph.D., and Craig L. Slingluff Jr., M.D., University of Virginia Health System
Safety Study of Adjuvant Vaccine to Treat Melanoma Patients (NCT01079741)
- 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