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The Clinical Accelerator brings together the best capabilities of the world’s leading academic researchers, drug companies, and a unique nonprofit venture fund to kick-start the development of powerful new treatments for cancer patients.

We have established a unique and mutually beneficial approach to partnering with biotech and pharmaceutical companies that has allowed us to gain access to several of the most highly sought-after immunotherapeutic agents for inclusion in next-generation CVC clinical studies. Below are clinical trials supported as of May 2017.

Clinical Trials


Safety and efficacy of APX005M with gemcitabine and nab-paclitaxel with or without Nivolumab in patients with previously untreated metastatic pancreatic adenocarcinoma (NCT03214250)

  • Robert H. Vonderheide, M.D., D.Phil., UPENN Abramson Cancer Center, Philadelphia, PA

A phase I study to evaluate the safety and tolerability of anti-PD-L1, durvalumab, in combination with tremelimumab in subjects with advanced solid tumors (NCT01975831)

  • Kunle Odunsi, M.D., Ph.D., Anna-Maria Kellen Clinical Investigator, Roswell Park Cancer Institute, Buffalo, NY
  • Patrick Ott, M.D., Ph.D., Dana-Farber Cancer Institute, Boston, MA
  • Jedd D. Wolchok, M.D., Ph.D., and Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center, New York, NY

Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC (NCT03164772)

  • Leena Gandhi, M.D., Ph.D., Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY

A phase I/II dose escalation study with expansion cohorts to investigate the safety, biologic and anti-tumor activity of ONCOS-102 in combination with durvalumab in subjects with advanced peritoneal malignancies (NCT02963831)

  • Dmitriy Zamarin, M.D., Ph.D., Memorial Sloan Kettering Cancer Center, New York, NY

A study of ALK inhibitor, ensartinib, and anti-PD-L1, durvalumab, in subjects with ALK-rearranged non-small cell lung cancer/a phase I/II study of combination immunotherapy and mRNA vaccine in subjects with non-small-cell lung cancer (NSCLC) (NCT02898116)

  • Leena Gandhi, M.D., Ph.D., NYU Langone Medical Center, New York, NY

A phase I/II study of in situ vaccination with tremelimumab and IV durvalumab plus Poly-ICLC in subjects with advanced, measurable, biopsy-accessible cancers (NCT02643303)

  • Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY
  • Craig L. Slingluff Jr., M.D., University of Virginia Health System, Charlottesville, VA

A phase II study to evaluate the clinical efficacy and safety of standards of care in combination with checkpoint blockade in patients with glioblastoma (NCT02336165)

  • David A. Reardon, M.D., Dana-Farber Cancer Institute, Boston, MA

Phase I/II study of chemo-immunotherapy with Toll-like receptor 8 agonist motolimod and checkpoint blockade in subjects with recurrent, platinum-resistant ovarian cancer for whom pegylated liposomal doxorubicin is indicated (NCT02431559)

  • George Coukos, M.D., Ph.D., University Hospital of Lausanne, Lausanne, Switzerland

A first-in-human single ascending dose study of TRX518 in subjects with unresectable stage III or stage IV malignant melanoma or other solid tumor malignancies (NCT01239134)

  • Henry Koon, M.D., University Hospitals, Cleveland, OH
  • Dale Shepard, M.D., Ph.D., Cleveland Clinic, Cleveland, OH
  • Jedd D. Wolchok, M.D., Ph.D., and Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center, New York, NY


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, Charlottesville, VA

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, Columbus, OH
  • Paul Sabbatini, M.D., Memorial Sloan Kettering Cancer Center, New York, NY

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, Osaka, 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, Osaka, 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, New York, NY

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, New York, NY

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, Charlottesville, VA

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, New York, NY

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, Charlottesville, VA

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, Charlottesville, VA

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, New York, NY

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, Charlottesville, VA

Role of Toll-like receptor 3 in macrophage-mediated programmed cell removal of tumor cells

  • Irving Weissman, M.D., Stanford University School of Medicine, Stanford, CA

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, Leiden, The Netherlands


Clinical Strategy Team Grants


The mutation-derived tumor landscape of advanced bladder cancer: A platform to optimize cancer immunotherapy

  • Team Leads: Nina Bhardwaj, M.D., Ph.D., and Sacha Gnjatic, Ph.D.
  • Investigators: Eric Schadt, Ph.D., Rachel Sabado, Ph.D., Matthew D. Galsky, M.D., Icahn School of Medicine at Mount Sinai, New York, NY

Immunotherapeutic targeting cell surface neoantigen SAS1B (Ovastacin, ASTL)

  • Team Lead: John C. Herr, Ph.D., University of Virginia Health System, Charlottesville, VA
  • Investigators: Victor Engelhard, Ph.D., Craig Slingluff, M.D., and Timothy Bullock, Ph.D., and Mark Kester, Ph.D., University of Virginia Health System, Charlottesville, VA; Jamal Zweit, Ph.D., Virginia Commonwealth University, Richmond, VA

Enhancing T cell homing to solid cancers by stimulating proper chemokines

  • Team Leads: Hideho Okada, M.D., Ph.D., and Lawrence Fong, M.D., University of California, San Francisco, San Francisco, CA
  • Investigators: Robert P. Edwards, M.D., Pawel Kalinski, Ph.D., University of Pittsburgh School of Medicine, Pittsburgh, PA; Kunle Odunsi, M.D., Ph.D., Roswell Park Cancer Institute, Buffalo, NY

Targeting the tumor immune microenvironment to enhance immune-stimulating effects of chemoradiotherapy

  • Team Lead: Andrew Sikora, M.D., Ph.D., Baylor College of Medicine, Houston, TX
  • Investigators: Sacha Gnjatic, Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY; Christine Chung, M.D., Moffitt Cancer Center, Tampa, FL; Nham Tran, Ph.D., University of Technology, Sydney, Australia; Cornelis J.M. Melief, M.D., Ph.D., Leiden University, Leiden, The Netherlands

Targeting adenosine in the tumor microenvironment

  • Team Lead: Mark J. Smyth, Ph.D., FAHMS, QIMR Berghofer Medical Research Institute, Brisbane, Australia
  • Investigators: Scott J. Antonia, M.D., Ph.D., Moffitt Cancer Center, Tampa, FL; Georgina V. Long, Ph.D., M.B.B.S., and Richard Scolyer, M.B.B.S., M.D., Melanoma Institute of Australia and University of Sydney, Sydney, Australia; John Stagg, Ph.D., University of Montréal, Montréal, Canada

Targeting multiple inhibitory receptors in cancer patients

  • Team Leads: Hassane M. Zarour, M.D., and John M. Kirkwood, M.D.
  • Investigators: James J. Lee, M.D., Mark A. Socinsky, M.D., Adam M. Brufsky, M.D., Ph.D., University of Pittsburgh School of Medicine, Pittsburgh, PA; Alan J. Korman, Ph.D., Bristol-Myers Squibb, Redwood City, CA
     

Tipping the balance in the tumor microenvironment as a next generation platform for pancreatic cancer immunotherapy

  • Team Lead: Lei Zheng, M.D., Ph.D.
  • Investigators: Elizabeth Jaffee, M.D., Eric Lutz, Ph.D., Todd Armstron, Ph.D., Johns Hopkins University School of Medicine, Baltimore, MD


Correlative and Laboratory Studies


Early-phase NY-ESO-1 clinical trials in patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and monitoring of tumor-specific immune responses

  • Maha Ayyoub, Ph.D., Institut Gustave Roussy, Villejuif, France

Phase II study of CTLA-4 blockade and low dose cyclophosphamide in patients with advanced malignant melanoma after failure of at least one prior therapy

  • Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY, and Anna C. Pavlick, D.O., NYU Langone Medical Center, New York, NY

Immunological monitoring for Cancer Vaccine Collaborative trials

  • Sacha Gnjatic, Ph.D., Icahn School of Medicine at Mount Sinai, New York, NY

Core support for NY-ESO-1 clinical trials

  • Elke Jäger, M.D., Krankenhaus Nordwest, Frankfurt, Germany

Vaccination of melanoma patients (stage II-IV) with ImmuFact IMP321, tumor antigenic peptides, and Montanide

  • Daniel E. Speiser, M.D., University Hospital of Lausanne, Lausanne, Switzerland

Early-phase NY-ESO-1 clinical trials in patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and monitoring of tumor-specific immune responses

  • Danila Valmori, Ph.D., Centre de Lutte Contre Le Cancer Nantes-Atlantique, Nantes-Saint Herblain, France
     

*Immunotherapy results may vary from patient to patient.

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