The CRI Anna-Maria Kellen Clinical Accelerator

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  • Overview
  • Components
  • Clinical Trials
  • Press
$127 Million Invested
19 Trials Supported
850+ Patients Treated
65+ Articles Published

The CRI Anna-Maria Kellen Clinical Accelerator is a unique nonprofit-academia-industry collaboration model that serves as an “incubator” for multi-center clinical trials testing promising new cancer immunotherapy combinations. As the Cancer Research Institute (CRI)’s clinical program, it enables integrative science-driven collaborative clinical research platforms to de-risk cancer immunotherapy drug development in a manner that leverage’s CRI philanthropic venture funding of clinical studies.

 

Clinical Accelerator Components

The CRI Anna-Maria Kellen Clinical Accelerator, supported by CRI’s venture philanthropy fund, fosters a cooperative environment that enables leading academic researchers to advance their most ambitious ideas into clinical development. In addition, it accelerates clinical studies that no one group or pharmaceutical company could do alone, bringing promising new treatment options to cancer patients.

Venture Fund
CRI VENTURE PHILANTHROPY FUND

Philanthropic dollars fuel the CRI Venture Fund, which deploys capital to accelerate the creation and execution of innovative immunotherapy clinical trials that aim to improve clinical outcomes for cancer patients.

The CRI Venture Fund realizes returns on its invested capital based on the clinical and regulatory development of the therapeutics it financially supports. Milestone payments (returns) are based on predetermined clinical and regulatory triggers. Earned milestone payments are then available to support future clinical studies through the CRI Venture Fund.
Research Network
GLOBAL CLINICAL RESEARCH NETWORK

The CRI Clinical Accelerator research network includes more than 90 of the world’s leading physician-scientists who have expertise in diverse clinical practices, cancer immunotherapy clinical trials, and immune monitoring. CRI’s leadership position in advancing cancer immunologyresearch for more than 65 years has yielded deep relationships with a global network of scientists, clinicians, and research institutions. Based on their areas of expertise, our researchers are organized into different focus groups, called drug selection committees. These committees propose science-based, biologically driven immunotherapy combinations to be studied in our clinical trials. These proposals are prioritized by the Clinical Accelerator leadership team, financed by our Venture Philanthropy Fund, and made possible through our robust relationships with academia and industry.

Meet Our Investigators
IO Landscape
IMMUNO-ONCOLOGY LANDSCAPE ANALYSES

The CRI Clinical Accelerator immuno-oncology landscape analyses present unbiased, scientifically curated, and routinely updated overviews of new investigational I-O agents and cancer immunotherapy clinical trials. These analyses allow the Clinical Accelerator to identify opportunities where the testing of novel immunotherapy combinations can generate the most impact. Thus, CRI is better able to support our global research network in creating rational, non-duplicative clinical trials. The results of our analyses are made available to the public on our website in addition to publication in peer-reviewed scientific journals.

View Our Landscape
Centralized Access
Centralized Access to Therapies

The CRI Clinical Accelerator team actively monitors the rapidly evolving cancer immunotherapy landscape and works directly with industry and nonprofit organizations to source innovative agents for evaluation in our clinical trials. These strategic partnerships have enabled access to more than 40 different clinical-stage agents to date. Our drug selection committees propose how combinations of these agents should be studied in the clinic by members of our global research network. Such combinations include checkpoint inhibitors, therapeutic vaccines, immunomodulators, oncolytic viruses, and many other promising treatments and technologies with high therapeutic potential.
Leadership
CLINICAL ACCELERATOR LEADERSHIP

The Clinical and Scientific Advisory Committee guides the clinical vision, strategy, and studies of the Clinical Accelerator. The management team is composed of highly experienced professionals with relevant experience in immunology, business development, regulatory sponsorship, clinical trial management, and data analysis and reporting. This team works closely with members of the scientific leadership in developing, implementing, and executing CRI-sponsored clinical trials.

Meet Our Leadership
Partnerships
Nonprofit and Academic Partnerships

The CRI Clinical Accelerator leverages relationships with nonprofits and companies to fund and deliver multi-center studies that could not be accomplished alone. Through these global partnerships, we advance ambitious clinical and translational research aimed at expanding the benefits of immunotherapy to more patients and, ultimately, curing cancer. Our partners provide key support to the program by contributing strategic direction and managing the logistical operations of our trials. They also provide critical funding and/or access to emerging technologies and therapeutic agents. The CRI Clinical Accelerator is proud to be supported by these outstanding organizations and welcomes new partnerships to de-risk novel combination strategies in immuno-oncology.

Meet Our Partners
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Clinical Accelerator Trials

The CRI Anna-Maria Kellen Clinical Accelerator aims to reduce inefficiencies and duplicative efforts by building multi-site, multi-company platform trials with deep translational and correlative science to advance immunotherapy. Below are clinical trials supported by the Clinical Accelerator as of February 2021.

Clinical Trials - Enrolling
 

ILIAD-7-US-O-InterLeukin-7 to improve Clinical Outcomes in Lymphopenic Patients with COVID-19 Infection (NCT04426201)

  • Joseph Nates, M.D., MD Anderson Cancer Center
  • Marcel van den Brink, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (Study chair)
  • Stephen M. Pastores, M.D., Memorial Sloan Kettering Cancer Center

Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients with NSCLC (NCT04093167)

  • Adrian Sacher, M.D., Princess Margaret Cancer Centre
  • Andrea Fung, M.D., Ph.D., Kingston Health Sciences Centre
  • Cheryl Ho, M.D., Vancouver Cancer Centre
  • Garth Nicholas, M.D., The Ottawa Hospital Research Institute
  • Peter Ellis, M.D., Juravinski Cancer Centre at Hamilton Health Sciences
  • Valsamo (Elsa) Anagnostou, M.D., Johns Hopkins University (Study chair)

Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (PORTER) (NCT03835533)

  • Charles Drake M.D., Ph.D., Columbia University
  • Julie Graff, M.D., Oregon Health & Science University
  • Karen Autio, M.D., Memorial Sloan Kettering Cancer Center
  • Kristopher Weintzel, M.D., Angeles Clinic
  • Larry Fong, M.D., University of California, San Francisco
  • Matt Galsky, M.D., Mount Sinai
  • Sumit Subhudhi, M.D., Ph.D., MD Anderson Cancer Center (Study chair)

Treatment with Nivolumab and Ipilimumab or Nivolumab Alone According to the Percentage of Tumoral CD8 Cells in Advanced Metastatic Cancer (NCT03651271)

  • Alexandra Drakaki, M.D., Ph.D., University of California, Los Angeles
  • Apostolia Tsimberidou, M.D., Ph.D., MD Anderson Cancer Center
  • Danny Khalil, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
  • David Oh, M.D., Ph.D., University of California, San Francisco
  • Padmanee Sharma, M.D., Ph.D., MD Anderson Cancer Center (Study chair)
  • Saad Khan, M.D., Stanford University
  • Stephen Hodi, M.D., Dana Farber Cancer Institute

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

  • Hirva Mamdani, M.D., Karmanos Cancer Institute
  • Jhanelle Gray, M.D., Moffitt Cancer Center (Study chair)
  • Jiaxin Niu, M.D., Banner MD Anderson
  • Jonathan Thompson, M.D., Medical College of Wisconsin
  • Joshua Sabari, M.D., NYU Langone

A Phase 1/2 Study to Investigate the Safety, Biologic and Anti-Tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects with Advanced Peritoneal Malignancies (NCT02963831)

  • Augustin Pimental, M.D., University of Miami
  • Danae Hamouda, M.D., University of Toledo
  • Dmitriy Zamarin, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (Study chair)
  • Emese Zsiros, M.D., Roswell Park Cancer Institute
  • Hitendra Patel, M.D., University of California, San Diego
  • Linda Duska, M.D., University of Virginia Health

Results

A Phase 1/2 Study of In Situ Vaccination with Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers (NCT02643303)

  • Craig Slingluff Jr., M.D., University of Virginia Health (Study chair)
  • Danae Hamouda, M.D., Toledo University
  • Elizabeth Gaughan, M.D., University of Virginia Health
  • Igor Puzanov, M.D., Roswell Park Cancer Institute
  • Keisuke Shirai M.D., Dartmouth University
  • Megan Kruse, M.D., Cleveland Clinic       
  • Michael Lowe, M.D., Emory University
  • Nina Bhardwaj, M.D., Ph.D., Mount Sinai (Study chair)

Results

Clinical Trials - Enrollment Complete
 

Safety and Efficacy of APX005M with Gemcitabine and Nab-Paclitaxel with or without Nivolumab in Patients with Previously Untreated Metastatic Pancreatic Adenocarcinoma (NCT03214250)

  • Andrew Ko, M.D., University of California, San Francisco
  • Eileen O’Reilly, M.D., Memorial Sloan Kettering Cancer Center
  • George Ficher, M.D., Stanford University
  • Mark O’Hara, M.D., University of Pennsylvania
  • Osama Rahma, M.D., Dana-Farber Cancer Institute
  • Robert Vonderheide, M.D., D.Phil., University of Pennsylvania (Study chair)
  • Robert Wolff, M.D., MD Anderson Cancer Center
  • Zev Wainberg, M.D., University of California, Los Angeles

Results

Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer (NCT02431559)

  • Blanca Navarro, M.D., University Hospital of Lausanne, Lausanne, Switzerland
  • Bradley Monk, M.D., Arizona Oncology
  • David O’Malley, M.D., Ohio State University
  • George Coukos, M.D., Ph.D., University Hospital of Lausanne, Lausanne, Switzerland (Study chair)
  • Paul DiSilvestro, M.D., Woman and Infants Hospital
  • Roisin O’Cearbhail, M.D., Memorial Sloan Kettering Cancer Center

Results

Phase 2 Study of Durvalumab (MEDI4736) in Patients with Glioblastoma (NCT02336165)

  • David Reardon, M.D., Dana-Farber Cancer Institute (Study chair)
  • Gavin Dunn, M.D., Ph.D., Washington University, St Louis
  • Hui Gan, M.D., Austin Hospital, Australia
  • Jennifer Clarke, M.D., M.P.H., University of California, San Francisco
  • Jorg Dietrich, M.D., Mass General Hospital
  • Michael Lim, M.D., Johns Hopkins
  • Thomas Kaley, M.D., Memorial Sloan Kettering Cancer Center
  • Tim Cloughesy, M.D., University of California, Los Angeles

Results

A Phase 1 Study to Evaluate MEDI4736 in Combination with Tremelimumab (NCT01975831)

  • Antoni Ribas, M.D., Ph.D., University of California, Los Angeles   
  • Jedd Wolchok, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (Study chair)
  • Kunle Odunsi, M.D., UChicago Medicine Comprehensive Cancer Center
  • Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (Study chair)
  • Mario Sznol, M.D., Yale University
  • Patrick Dillon M.D., University Virginia Health
  • Patrick Ott, M.D., Dana-Farber Cancer Institute
  • Reva Schneider, M.D., Mary Crowley Cancer Center

Results

Clinical Trials - Completed
 

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

Results

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

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Clinical Accelerator Press

The CRI Anna-Maria Kellen Clinical Accelerator team and affiliated scientists publish our new developments and contributions in the field of immunotherapy in prestigious journals, blog posts, and press releases.

Press Releases
 

Publications
 

Media Mentions
 

Blog Articles
 
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*Immunotherapy results may vary from patient to patient.

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