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The CRI Anna-Maria Kellen Clinical Accelerator

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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.

Meet Our Investigators

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.

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 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.

Meet Our Leadership

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.

Meet Our Partners

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

Zamarin D, et al. Abstract presented at the 2020 ASCO Virtual Scientific Program (May 29-31, 2020).

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

Slingluff CL, Dasilva D, Schwarzenberger P, et al. Phase 1/2 study of in situ vaccination with tremelimumab + intravenous (IV) durvalumab + poly-ICLC in patients with select relapsed, advanced cancers with measurable, biopsy-accessible tumors. Journal of Clinical Oncology. 2018.
Slingluff CL, et al. Abstract #P246 presented at SITC 2017 Annual Meeting (November 8-12, 2017).

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

O'Hara M, O'Reilly E, Varadhachary G et al. CD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open-label, multicentre, phase 1b study. The Lancet Oncology. 2021.
O'Hara M, O'Reilly E, Rosemarie M et al. Abstract CT004. A Phase Ib study of CD40 agonistic monoclonal antibody APX005M together with gemcitabine (Gem) and nab-paclitaxel (NP) with or without nivolumab (Nivo) in untreated metastatic ductal pancreatic adenocarcinoma (PDAC) patients. Clinical Trials. 2019. (Abstract presented at AACR Annual Meeting 2019, March 29, 2019, by Mark O'Hara.)

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

O'Cearbhaill RE, et al. Abstract presented at the Society of Gynecologic Oncology (SGO) 2020 Annual Meeting on Women’s Cancer Webinar Series: Developmental Therapeutics in Gynecological Cancer Webinar. May 28, 2020.
O'Cearbhaill R.E., Wolfer A. et al. A phase 1/2 study of chemo-immunotherapy with durvalumab (durva) and pegylated liposomal doxorubicin (PLD) in platinum-resistant recurrent ovarian... Annals of Oncology (2018) 29 (suppl_8): viii332-viii358. (Abstract presented at ESMO 2018 Congress, Poster display session, 20 October 2018, by Roisin O'Cearbhaill.)

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

Reardon DA, Kaley TJ, Dietrich J, et al. Phase II study to evaluate safety and efficacy of MEDI4736 (durvalumab) + radiotherapy in patients with newly diagnosed unmethylated MGMT glioblastoma (new unmeth GBM). Journal of Clinical Oncology. 2019.
Reardon D, Kaley T, Dietrich J, et al. ATIM-38. PHASE 2 STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF MEDI4736 (DURVALUMAB, DURVA) + BEVACIZUMAB (BEV) IN BEV-NAÏVE PATIENTS WITH RECURRENT GLIOBLASTOMA (GBM). Neuro-Oncology. November 2018;20(suppl_6):vi10-vi10.
Reardon D, Kaley T, Dietrich J, et al. ATIM-12. PHASE 2 STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF MEDI4736 (DURVALUMAB [DUR]) IN PATIENTS WITH BEVACIZUMAB (BEV)-REFRACTORY RECURRENT GLIOBLASTOMA (GBM). Neuro-Oncology. November 2017;19(suppl_6):vi28-vi28.
Casey Allie. Checkpoint Inhibitors Show Promise in Glioblastoma. OncLive.com. Published: Friday, Nov 18, 2016.

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

Callahan MK, Odunsi K, Sznol M, et al. Phase 1 study to evaluate the safety and tolerability of MEDI4736 (durvalumab, DUR) + tremelimumab (TRE) in patients with advanced solid tumors. Journal of Clinical Oncology. 2018.

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

Zappasodi R, Sirard C, Li Y, et al. Rational design of anti-GITR-based combination immunotherapy. Nature Medicine. 2019. Rational design of anti-GITR-based combination immunotherapy.
Koon HB, Shepard DR, Merghoub T, Schaer DA, Sirard CA, Wolchok JD. First-in-human phase 1 single-dose study of TRX-518, an anti-human glucocorticoid-induced tumor necrosis factor receptor (GITR) monoclonal antibody in adults with advanced solid tumors. Journal of Clinical Oncology. 2018.

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