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Immune Checkpoint Inhibitors: Clinical Trial Tracker

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    July 2016

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Oncology market, for decades, has been pillared on three areas: Surgery, Radiation Therapy and Chemotherapy. Immuno-oncology, especially immune checkpoint inhibitors, has recently gained traction from several stakeholders. Immune checkpoints are molecules that regulate (stimulate or inactivate) the immune cells. Yervoy (an anti CTLA-4 inhibitor) was the first immune checkpoint inhibitor that was made commercially available in 2011 for treatment of patients suffering from unresectable or metastatic melanoma; it has enjoyed considerable success so far with annual sales of over USD 1 billion. The drug is currently being mirrored by various other drugs such as Opdivo, Keytruda, Empliciti and Tecentriq in clinical development.

The market, with an opportunistic development pipeline, caters to the participation of various market players (big and small) over a common platform.The field has been abuzz with partnering activities; such collaborations provide a synergistic boom to both the partners in terms of enrichment of product portfolio, revenues and stability. Most common forms of partnerships include clinical trial collaborations, product licensing agreements, acquisitions and research collaborations.

In addition to the marketed drugs, we expect a number of drugs currently in advanced stages of development to achieve blockbuster status in the near future. The anticipated success of immune checkpoint inhibitors shall prove to be a harbinger for emerging players and a strong impetus to the development pace of the other pharmaceutical giants.


Scope of the Report

The primary objective of this report is to capture details on the various clinical trials that are currenly underway in the field of immune checkpoint inhibitors.We have identified a number of immune checkpoint inhibitors and clinical trials that are either being conducted or planned to be conducted for each of these drugs. 

For each specific product, we have provided the following information:

  • Primary Drug
  • Highest Phase of Development
  • Manufacturer / Licensee
  • Target Receptor
  • Molecule Type
  • Route of Administration

For each specific trial, we have provided the following information:

  1. Indication
  2. Therapeutic Area
  3. Type of Cancer
  4. Sponsor/Collaborator
  5. Trial Title
  6. Trial Objective
  7. Trial Phase
  8. Trial Status
  9. Start Date
  10. End Date
  11. Enrolment
  12. Age Group
  13. Age Range
  14. Gender
  15. Inclusion Criteria
  16. Exclusion Criteria
  17. Study Type
  18. Study Design
  19. Primary Endpoints
  20. Secondary Endpoints
  21. Other Endpoints
  22. Treatment Arm(s)
  23. Location(s)
  24. Primary Trial Identifier
  25. Other Identifiers
  26. Trial Results (if known)

The above information has also been presented in the form a dashboard to provide a high level quick overview of the ongoing activity in this space.

In addition to the clinical trial details, the report also provides the following:

Drivers and Restraints of the specific drug classes (CTLA-4 inhibitors, PD-1 / PDL-1 inhibitors and novel immune checkpoint inhibitors), wherein we have presented our opinion on the drivers and challenges associated with each of the drug class type.

Sales forecast of the immune checkpoint inhibitors market over the course of next ten years. Owing to the emerging nature of this market, we have presented three scenarios to add robustness to our market forecast. The conservative, base and optimistic scenarios represent three different tracks of industry evolution.


Introduction and Pipeline Details

1. Market Overview
2. Dashboard: Pipeline and Trial Analysis
3. CTLA-4 Inhibitors: Trial Details
4. PD-1 Inhibitors: Trial Details
5. PDL-1 Inhibitors: Trial Details
6. Novel Immune Checkpoint Inhibitors: Trial Details
7. Molecules in Preclinical Development
8. Inclusion / Exclusion Criteria
9. Drivers and Restraints
10. Market Forecast: Assumptions
11. Market Forecast, 2016-2025

List of Figures

Pipeline and Trial Details
Figure 1 Immune Checkpoint Inhibitors in Clinical Development: Distribution by Highest Phase of Development
Figure 2 Immune Checkpoint Inhibitors in Clinical Development: Distribution by Target
Figure 3 Immune Checkpoint Inhibitors in Clinical Development: Distribution by Phase of Development and Companies
Figure 4 Immune Checkpoint Inhibitors in Clinical Development: Distribution by Type of Molecule
Figure 5 Immune Checkpoint Inhibitors in Clinical Development: Distribution by Key Players
Figure 6 Immune Checkpoint Inhibitors Clinical Trials: Distribution by Trial Phase
Figure 7 Immune Checkpoint Inhibitors Clinical Trials: Distribution by Trial Status
Figure 8 Immune Checkpoint Inhibitors Clinical Trials: Distribution by Sponsor Type
Figure 9 Immune Checkpoint Inhibitors Clinical Trials: Distribution by Tumor Type
Figure 10 Immune Checkpoint Inhibitors Clinical Trials: Distribution by Study Type
Figure 11 Immune Checkpoint Inhibitors Clinical Trials: Distribution by Gender Type
Figure 12 Immune Checkpoint Inhibitors Clinical Trials: Distribution by Molecule Type and Target
Figure 13 Immune Checkpoint Inhibitors Clinical Trials Design: Distribution by Allocation Type
Figure 14 Immune Checkpoint Inhibitors Clinical Trials Design: Distribution by Endpoint Classification
Figure 15 Immune Checkpoint Inhibitors Clinical Trials Design: Distribution by Interventional Model
Figure 16 Immune Checkpoint Inhibitors Clinical Trials Design: Distribution by Observational Model
Figure 17 Immune Checkpoint Inhibitors Clinical Trials Design: Distribution by Masking
Figure 18 Immune Checkpoint Inhibitors Clinical Trials Design: Distribution by Primary Purpose
Figure 19 Immune Checkpoint Inhibitors Clinical Trial Locations: Distribution by Continent
Figure 20 Immune Checkpoint Inhibitors Clinical Trial Locations: Distribution by G7 Countries
Figure 21 Immune Checkpoint Inhibitors Clinical Trial Locations: Distribution by EU5 Countries
Figure 22 Immune Checkpoint Inhibitors in Preclinical Development: Distribution by Companies

Drivers and Restraints
Figure A: CTLA-4 Inhibitors: Drivers and Restraints
Figure B: PD-1 and PDL-1 Inhibitors: Drivers and Restraints
Figure C: Novel Immune Checkpoint Inhibitors: Drivers and Restraints

Market Forecast Analysis
Figure A: Immune Checkpoint Inhibitors Market Forecast, 2016-2025

List of Tables

Pipeline Analysis
Table A Companies Involved in the Development of Preclinical Immune Checkpoint Inhibitorst
Pipeline Details
Table 1 CTLA-4 Inhibitors Clinical Development: Pipeline Details 
Table 2 PD-1 Inhibitors Clinical Development: Pipeline Details 
Table 3 PDL-1 Inhibitors Clinical Development: Pipeline Details 
Table 4 Novel Immune Checkpoint Inhibitors Clinical Development: Pipeline Details 
Table 5 Preclinical Development
Market Forecast Analysis
Table A Market Forecast: Assumptions 

Listed Companies

The following companies and organisations have been mentioned in the report:

  1. Aarhus University Hospital 
  2. Abbott
  3. AbbVie
  4. Academic and Community Cancer Research United
  5. Acerta Pharma BV
  6. Acetylon Pharmaceuticals
  7. ACT Oncology
  8. Adknoma Health Research
  9. AduroBioTech
  10. Advaxis
  11. Affimed
  12. Agenus
  13. AgonOx
  14. AHS Cancer Control Alberta
  15. AIO-Studien-gGmbH
  16. Alden Cancer Therapy II
  17. Alliance Foundation Trials
  18. Alligator Bioscience
  19. Altor Bioscience
  20. Ambrx
  21. American Association for Cancer Research
  22. Amgen
  23. Amplimmune
  24. AnaptysBio
  25. Apexigen
  26. arGEN-X
  27. ARMO BioSciences
  28. Astex Pharmaceuticals
  29. AstraZeneca
  30. Aurigene
  31. Australasian Lung Cancer Trials Group
  32. Australia and New Zealand Melanoma Trials Group
  33. Australian and New Zealand Urogenital and Prostate Cancer Trials Group 
  34. Avon Breast Cancer Foundation
  35. Azienda Ospedaliera Universitaria Senese
  36. Bank of Cyprus Oncology Centre
  37. Barbara Ann Karmanos Cancer Institute
  38. Bayer
  39. Baylor College of Medicine
  40. BeiGene
  41. BioInvent
  42. Bio-Matrix Scientific Group
  43. BioNovion
  44. Boston Biomedical
  45. Bristol-Myers Squibb
  46. Brown University
  47. California Pacific Medical Center Research Institute
  48. Calithera Biosciences
  49. Canadian Cancer Trials Group
  50. Cancer Prevention Research Institute of Texas
  51. Cancer Research Institute New York City
  52. Cancer Research UK
  53. Case Comprehensive Cancer Center
  54. Cedars-Sinai Medical Center
  55. Celgene
  56. Cell Genesys
  57. Celldex Therapeutics
  58. Cellerant Therapeutics
  59. Center for Cell and Gene Therapy Baylor College of Medicine
  60. Central and Eastern European Oncology Group
  61. Centre hospitalier de l'Université de Montréal
  62. Centre Hospitalier Universitaire de Nice
  63. Centre Hospitalier Universitaire Vaudois
  64. Checkmate Pharmaceuticals
  65. Checkpoint Therapeutics
  66. Children's Hospital Los Angeles
  67. City of Hope Medical Center
  68. Clinica Universidad de Navarra
  69. Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  70. Clovis Oncology
  71. Columbia University
  72. Comprehensive Cancer Center of Wake Forest University
  73. Comprehensive Cancer Centers of Nevada
  74. Compugen
  75. Copenhagen University Hospital at Herlev
  76. Corvus Pharmaceuticals
  77. Cure Brain Cancer Foundation
  78. CureTech
  79. Curis
  80. Dana-Farber Cancer Institute
  81. Delcath Systems
  82. Dendreon
  83. Department of Experimental Clinical Oncology
  84. Duke Cancer Institute
  85. Duke University
  86. Dutch Society of Physicians for Pulmonology and Tuberculosis 
  87. Dynavax Technologies
  88. Earle A. Chiles Research Institute
  89. Eastern Cooperative Oncology Group
  90. Eddingpharm
  91. Eisai
  92. Eli Lilly and Company
  93. EMD Serono
  94. Emory University
  95. Enumeral
  96. EpicentRx
  97. European CanCer Organisation
  98. European Organisation for Research and Treatment of Cancer
  99. European Thoracic Oncology Platform
  100. Experimental Cancer Medicine Centre Network
  101. Facet Biotech
  102. Ferring Pharmaceuticals
  103. Five Prime Therapeutics
  104. Fondation ARC
  105. Fondazione IRCCS Istituto NazionaledeiTumori
  106. Fondazione Melanoma Onlus
  107. Fondazione Michelangelo
  108. Fox Chase Cancer Center
  109. Fred Hutchinson Cancer Research Center
  110. Frontier Science Foundation
  111. Galectin Therapeutics
  112. Gateway for Cancer Research
  113. Genentech
  114. Georgetown University
  115. Georgia Regents University
  116. German Breast Group
  117. GITR
  118. GlaxoSmithKline
  119. Gradalis
  120. Groupe Oncologie RadiotherapieTete et Cou
  121. Grupo Español Multidisciplinar de Melanoma
  122. H. Lee Moffitt Cancer Center and Research Institute
  123. Hackensack University Medical Center
  124. Hadassah Medical Organization
  125. Halozyme Therapeutics
  126. Haukeland University Hospital
  127. Heat Biologics
  128. Herlev Hospital
  129. High Impact Clinical Research Support Program
  130. Hoffmann-La Roche
  131. Honor Health Research Institute
  132. Hoosier Cancer Research Network
  133. Horizon Pharma Ireland
  134. Hospices Civils de Lyon
  135. Huntsman Cancer Institute
  136. HUYA Bioscience International
  137. Icahn School of Medicine at Mount Sinai
  138. Idera Pharmaceuticals
  139. Immune Design
  140. ImmuNext
  141. Immunocore
  142. ImmunoVaccine Technologies
  143. Immutep S.A.
  144. INC Research
  145. Incyte
  146. Infinity Pharmaceuticals
  147. Innate Pharma
  148. Institut Bergonié
  149. Institute of Cancer Research 
  150. Instituto Nacional de Cancerologia de Mexico
  151. Intergroupe Francophone de CancerologieThoracique
  152. International Breast Cancer Study Group
  153. IOmet Pharma
  154. ISA Pharmaceuticals
  155. Istituto Scientifico Romagnolo per lo Studio e la curadei Tumori
  156. Italian Network for Tumor Biotherapy Foundation
  157. iTeos Therapeutics
  158. James Graham Brown Cancer Center
  159. Janssen Pharmaceuticals
  160. Jewish General Hospital
  161. Johns Hopkins University
  162. Jonsson Comprehensive Cancer Center
  163. Jounce Therapeutics
  164. JSS Medical Research
  165. Kadmon Corporation
  166. KAHR Medical
  167. Karyopharm Therapeutics
  168. Kids' Cancer Research Foundation
  169. King Faisal Specialist Hospital & Research Center
  170. Korean Cancer Study Group
  171. Kyowa Hakko Kirin Company
  172. Ludwig Institute for Cancer Research
  173. M.D. Anderson Cancer Center
  174. MacroGenics
  175. Mary Crowley Medical Research Center
  176. Massachusetts General Hospital
  177. Mayo Clinic
  178. Medarex
  179. Medical College of Wisconsin
  180. Medical Research Council
  181. Medical University of Vienna
  182. MedImmune
  183. Medivation
  184. Melanoma Institute Australia
  185. Melanoma Research Alliance
  186. Memgen
  187. Memorial Sloan Kettering Cancer Center
  188. Merck KGaA
  189. Merck Sharp & Dohme Corp.
  190. Millennium Pharmaceuticals
  191. Mologen AG
  192. Multimeric Biotherapeutics
  193. National Center for Tumor Diseases, Heidelberg
  194. National Health and Medical Research Council, Australia
  195. National Institute for Health Research, United Kingdom
  196. National Institute of Allergy and Infectious Diseases
  197. National Institutes of Health 
  198. Nativis
  199. NCRI Clinical Studies Groups
  200. New Mexico Cancer Care Alliance
  201. New York University School of Medicine
  202. NewLink Genetics
  203. NHS Greater Glasgow and Clyde 
  204. Northside Hospital
  205. Northwestern University
  206. Norwegian Cancer Society
  207. Norwegian Radium Hospital
  208. Novartis
  209. Ohio State University Comprehensive Cancer Center
  210. OHSU Knight Cancer Institute
  211. Oncolytics Biotech
  212. OncoMed Pharmaceuticals
  213. Oncothyreon
  214. Oncovir
  215. Ono Pharmaceutical
  216. Optimata
  217. Orega Biotech
  218. Oregon Health and Science University
  219. Oslo University Hospital
  220. Ozmosis Research
  221. Pelican Therapeutics
  222. Peloton Therapeutics
  223. Peregrine Pharmaceuticals
  224. Peter MacCallum Cancer Centre
  225. PETHEMA Foundation
  226. Pfizer
  227. Pharmaceutical Product Development
  228. Pharmacyclics
  229. Pieris Pharmaceuticals
  230. Plexxikon
  231. PRA Health Sciences
  232. Prima BioMed
  233. Prometheus Laboratories
  234. Prostate Oncology Specialists
  235. Provectus Pharmaceuticals
  236. Providence Cancer Center
  237. Providence Health & Services
  238. PsiOxus Therapeutics
  239. Quantum Leap Healthcare Collaborative
  240. Queen Mary University of London 
  241. Queen's University, Belfast
  242. Quintiles
  243. Reata Pharmaceuticals
  244. Regeneron Pharmaceuticals
  245. Rhode Island Hospital
  246. Robert H. Lurie Cancer Center
  247. Roche / Genentech
  248. Roswell Park Cancer Institute
  249. Rouen University Hospital
  250. Royal Marsden NHS Foundation Trust
  251. RTOG Foundation
  252. Rutgers Cancer Institute of New Jersey
  253. Samsung Medical Center
  254. Sanford Health
  255. Sanofi
  256. Sarcoma Alliance for Research through Collaboration
  257. Seattle Genetics
  258. Seoul National University Hospital
  259. Servier
  260. SGS Aster-Cephac
  261. Sheba Medical Center
  262. Sidney Kimmel Comprehensive Cancer Center
  263. Solving Kids’ Cancer
  264. Sorrento Therapeutics
  265. Southern Illinois University
  266. Southwest Oncology Group
  267. Spanish Lung Cancer Group
  268. St. Louis University
  269. Stand Up To Cancer
  270. Stanford University
  271. Sunnybrook Health Sciences Centre
  272. Swiss Group for Clinical Cancer Research
  273. Syndax Pharmaceuticals
  274. Takara Bio
  275. Tapimmune
  276. Tesaro
  277. TetraLogic Pharmaceuticals
  278. Texas Children's Hospital
  279. TG Therapeutics
  280. The EVAN Foundation
  281. The First People's Hospital of Changzhou
  282. The Leukemia and Lymphoma Society
  283. The Methodist Hospital System
  284. The Miriam Hospital
  285. The Netherlands Cancer Institute
  286. Theradex
  287. Theravectys
  288. Thomas Jefferson University
  289. ToleroTech
  290. Translational Genomics Research Institute
  291. Transplant Genomics
  292. U.S. Army Medical Research Acquisition Activity
  293. Ultimovacs
  294. Umanis
  295. UNC Lineberger Comprehensive Cancer Center
  297. United BioSource
  298. United States Department of Defense
  299. Universitair Ziekenhuis Brussel
  300. University College London
  301. University Health Network, Toronto
  302. University Hospital Dresden
  303. University Hospital Ghent
  304. University Hospital Heidelberg
  305. University Hospital Lille
  306. University Hospital Southampton NHS Foundation Trust
  307. University Hospital Tuebingen
  308. University Medical Center Groningen
  309. University of Birmingham
  310. University of California
  311. University of Chicago
  312. University of Colorado Denver
  313. University of Connecticut Health Center
  314. University of Edinburgh
  315. University of Glasgow
  316. University of Heidelberg Medical Center
  317. University of Leeds
  318. University of Leicester
  319. University of Louisville
  320. University of Manchester
  321. University of Michigan Cancer Center
  322. University of Minnesota
  323. University of Pennsylvania
  324. University of Pittsburgh
  325. University of Southampton
  326. University of Southern California
  327. University of Texas Southwestern Medical Center
  328. University of Utah
  329. University of Virginia
  330. University of Washington
  331. University of Wisconsin-Madison
  332. University of Zurich
  333. Vanderbilt University
  334. Vanderbilt-Ingram Cancer Center
  335. Vastra Gotaland Region 
  336. VentiRx Pharmaceuticals
  337. Verastem
  338. Viralytics
  339. Vrije Universiteit Brussel
  340. VU University Medical Center
  341. Washington University School of Medicine
  342. West Japan Oncology Group
  343. Western Regional Medical Center
  344. Yale University


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