The CRI Anna-Maria Kellen Clinical Accelerator

Let's spread the word about Immunotherapy! Click to share this page with your community.
  • Overview
  • Components
  • Clinical Trials
  • Press
$127 Million Invested
16 Trials Supported
850+ Patients Treated
40+ Papers Accepted

The Cancer Research Institute (CRI) Anna-Maria Kellen Clinical Accelerator is a unique academia-nonprofit-industry collaboration model that serves as an incubator that delivers multi-center, science-driven clinical trials of promising new cancer immunotherapy combinations. As CRI’s clinical program, the Clinical Accelerator enables an integrative collaboration approach designed to de-risk drug development in cancer immunotherapy through a leveraged philanthropic financial model.

Clinical Accelerator Components

The CRI Anna-Maria Kellen Clinical Accelerator, supported by CRI’s venture philanthropy fund, fosters a collaborative environment that enables leading academic researchers to advance their most ambitious ideas and to accelerate studies that one group or pharmaceutical company could not do alone.

Venture Fund
PHILANTHROPHIC CAPITAL VENTURE FUND

The CRI Venture Fund facilitates the development of immunotherapy combination trials by supporting a collaboration between academia, nonprofits, and industry. This program is made possible by generous donations from a group of cancer-concerned philanthropists. The CRI Venture Fund grants $20–$30 million annually in order to accelerate the creation and execution of innovative clinical trials in oncology designed to address unmet patient health needs while also advancing scientific understanding of immunotherapy’s impact on patient populations.

Revenue to support CRI Anna-Maria Kellen Clinical Accelerator studies is generated when pre-determined treatment milestones are reached and when FDA approvals are granted. This revenue is reinvested into the CRI Venture Fund, supporting the development and execution of additional clinical trials. In this manner, the CRI Venture Fund directly facilitates the advancement of immunotherapy, ultimately helping save more lives.

Research Network
GLOBAL CLINICAL RESEARCH NETWORK

The CRI Anna-Maria Kellen 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 immunological monitoring that produces in-depth correlative data that informs future immunotherapy trial designs. CRI’s leadership in immuno-oncology for over 65 years has generated a network of scientists at research institutions spanning more than ten countries. CRI scientists are organized into expert focus groups, called drug selection committees, based on their cancer type expertise and immuno-oncology research areas. These committees propose biologically-driven combination proposals to be studied in our clinical trials. These proposals are then supported through our robust relationships with academic institutions, nonprofit organizations, and industry companies.

IO Landscape
IMMUNO-ONCOLOGY LANDSCAPE ANALYSIS

The CRI Anna-Maria Kellen Clinical Accelerator analysis of the immuno-oncology landscape presents an unbiased, scientifically curated, and regularly updated summary of new investigational agents and trials in immuno-oncology. Through this analysis, the CRI Clinical Accelerator is uniquely positioned to identify areas of unmet need in novel immuno-oncology trial combinations. In this way, CRI is able to better support our physician-scientist global research network in creating science-driven, non-duplicative clinical trials. The results of our analyses are made available to the public on the CRI website in addition to publication in peer-reviewed scientific journals.

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 to be evaluated in our combination clinical trials. These strategic partnerships have thus far enabled access to 40+ different clinical-stage agents that can be used to support rationally-designed immunotherapy combination trials. The evaluated combinations are proposed by investigators in our drug selection committees. Such combinations include checkpoint inhibitors, therapeutic vaccines, immunomodulators, oncolytic viruses, and many other promising treatments and technologies with high therapeutic potential. Through our centralized access and strategic partnerships, CRI is able to make cutting-edge cancer immunotherapy combinations available to our global clinical research network.

Leadership
CLINICAL ACCELERATOR LEADERSHIP

The CRI Anna-Maria Kellen Clinical Accelerator is led by the world’s foremost authorities in their respective fields and disciplines including academic clinical research and immuno-oncology. Working with CRI’s management team consisting of highly experienced professionals, the CRI Clinical Accelerator Clinical and Scientific Advisory Committee helps guide the program’s overall scientific and clinical strategy. Drawing upon expertise from within CRI as well as our nonprofit partners, the program’s leadership offers a comprehensive suite of capabilities spanning regulatory sponsorship, protocol development, medical care and monitoring, data capture, reporting, and analysis.

Partnerships
Nonprofit and Academic Partnerships

The CRI Anna-Maria Kellen Clinical Accelerator seeks out and develops relationships with nonprofits and corporations to fund and deliver multi-center studies that one group or company could not accomplish alone. Through leveraging these global partnerships and collaborations, CRI advances ambitious clinical and translational research aimed at saving more lives and ultimately curing all cancers. Our partnerships 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 agents. The CRI Clinical Accelerator is proud to be supported by these dedicated organizations and welcomes new partnerships to de-risk novel combination strategies in immuno-oncology.

Clinical Accelerator Trials

The CRI Anna-Maria Kellen Clinical Accelerator aims to reduce inefficiencies and duplicative efforts across the field through building of multisite, multicompany platform trials that include deep translational correlative science to advance immunotherapy. Below are clinical trials supported by the Clinical Accelerator as of July 2020.

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., The University of Texas MD Anderson Cancer Center
  • Stephen Pastores, M.D., Memorial Sloan Kettering Cancer Center
  • Marcel van Den Brink, M.D., Ph.D., Memorial Sloan Kettering Cancer Center

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

  • Valsamo Anagnostou, M.D., Ph.D., Johns Hopkins University
  • Cheryl Ho, M.D., FRCPC, BCCA - Vancouver Cancer Centre
  • Garth Nicholas, M.D., FRCPC, The Ottawa Hospital Research Institute
  • Adrian Sacher, M.D., MMSc, FRCPC, University Health Network Princess Margaret Cancer Centre

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

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

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

  • Padmanee Sharma, M.D., Ph.D., MD Anderson Cancer Center
  • Alexandra Drakaki, M.D., University of California, Los Angeles
  • Stephen Hodi, M.D., Dana-Farber Cancer Institute
  • Danny Khalil, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
  • Shivaani Kummar, M.D., FACP, Stanford University
  • David Oh, M.D., University of California, San Franscisco
  • Lawrence Fong, M.D., University of California, San Francisco

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

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

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)

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

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)

  • Nina Bhardwaj, M.D., Ph.D., Icahn School of Medicine at Mount Sinai
  • Craig L. Slingluff Jr., M.D., University of Virginia Health System
  • Megan Kruse, M.D., Cleveland Clinic
  • Michael Lowe, M.D., Emory University Hospital
  • Keisuke Shirai, M.D., Dartmouth-Hitchock Medical Center
  • Elizabeth Gaughan, M.D., University of Virginia Health
  • Igor Puzanov, M.D., Roswell Park Cancer Institute
  • Danae Hamouda, M.D., Toledo University

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)

  • Robert H. Vonderheide, M.D., D.Phil., UPENN Abramson Cancer Center
  • George Fischer, M.D., Stanford University
  • Andrew Ko, M.D., University of California, San Francisco
  • Mark O’Hara, M.D., UPENN Abramson Cancer Center
  • Eileen O’Reilly, M.D., Memorial Sloan Kettering Cancer Center
  • Osama Rahma, M.D., Dana Farber Cancer Institute
  • 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)

  • George Coukos, M.D., Ph.D., University Hospital of Lausanne Switzerland
  • Bradley J. Monk, M.D., St Joseph’s Hospital and Medical Center
  • Roisin E. O'Cearbhaill, M.D., Memorial Sloan-Kettering Cancer Center
  • Angela Orcurto, M.D., CHUV, Lausanne, Switzerland
  • David O’Malley, M.D., Ohio State University
  • Paul DiSilvestro, M.D., Woman and Infants Hospital

Results

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

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

Results

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

  • Jedd D. Wolchok, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
  • Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
  • Kunle Odunsi, M.D., Ph.D., Roswell Park Cancer Institute
  • Patrick Ott, M.D., Ph.D., Dana-Farber Cancer Institute
  • Antoni Ribas, M.D., Ph.D., University of California, Los Angeles
  • Patrick M. Dillon, M.D., University of Virginia Health System
  • Mario Sznol, M.D., Yale University
  • 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

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

Clinical Accelerator Press

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

Press Releases
 

Publications
 

Media Mentions
 

*Immunotherapy results may vary from patient to patient.

Top