ACT IV: Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

• Sponsor: Celldex Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01480479
• Collaborator: (none)
• Enrollment: 745
• Locations: 223
• Arms: 2
• Duration (Months): 60
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma; Small Cell Glioblastoma; Giant Cell Glioblastoma; Gliosarcoma; Glioblastoma With Oligodendroglial Component	Drug: Rindopepimut (CDX-110) with GM-CSF; Drug: Temozolomide; Drug: KLH	Phase 3

Detailed Description

The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug temozolomide can help improve the life expectancy of patients with newly diagnosed, resected EGFRvIII positive glioblastoma.

The duration of participation in this study may be up to 5 years. After you are screened and enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF or KLH until either disease progression or intolerance to the medications. If your tumor progresses while on this study, your doctor may treat you with other therapies that are not part of the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 745 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rindopepimut/GM-CSF plus Temozolomide	Drug: Rindopepimut (CDX-110) with GM-CSF; Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.; Other Names: CDX-110 with sargramostim (GM-CSF) (Leukine®) ; Drug: Temozolomide; 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.; Other Names: Temodar Temodal
Active Comparator: KLH plus Temozolomide	Drug: Temozolomide; 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.; Other Names: Temodar Temodal ; Drug: KLH; Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.

Outcome Measures

Primary Outcome Measures

1. Overall Survival [During treatment and every three months from end of treatment through end of study or approximately up to 5 years.]

   The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.

Secondary Outcome Measures

1. Progression-free survival [Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy]

   Compare progression-free survival between the two treatment arms

2. Safety and Tolerability [Until day 28 of follow up]

   Safety and tolerability will be measured by comparing the two arms in regards to vital sign measurement, physical and neurological examination, adverse events reporting, ECOG performance status, and EORTC core Quality of Life Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria-

Among other criteria, patients must meet the following conditions to be eligible for the study:

1. Adult patients, ≥ 18 years old

2. Newly diagnosed glioblastoma

3. Attempted surgical resection followed by conventional chemoradiation

4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory

5. No evidence of progressive disease from the post-operative period to the post-chemoradiation period

6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy

7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization

8. WHO-ECOG Performance Status ≤ 2

9. Patients of childbearing/reproductive potential will be instructed to use birth control as defined by your doctor.

Exclusion Criteria-

Among other criteria, patients who meet the following conditions are NOT eligible for the study:

1. Stereotactic biopsy only (without further surgical resection)

2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.

3. History, presence, or suspicion of metastatic disease

4. Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide

5. Active systemic infection requiring treatment

6. History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer, cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other carcinoma in situ that has been adequately treated and cured.

7. Planned major surgery

8. Evidence of current drug or alcohol abuse

9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins

10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial

11. Women who are pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama	United States	36604
3	Barrow Neurological Institute at St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
4	University of Arizona Health Network	Tucson	Arizona	United States	85724
5	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
6	City of Hope Cancer Center	Duarte	California	United States	91010
7	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
8	USC Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
9	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
10	Kaiser Permanente, Redwood City Medical Center	Redwood City	California	United States	94063
11	University of California, Davis	Sacramento	California	United States	95817
12	University of California, San Francisco	San Francisco	California	United States	94143
13	Stanford Cancer Institute, Stanford University	Stanford	California	United States	94305
14	Hartford Hospital	Hartford	Connecticut	United States	06102
15	Yale University Medical Center	New Haven	Connecticut	United States	06520
16	Christiana Care Health Services	Newark	Delaware	United States	19713
17	University of Florida	Gainesville	Florida	United States	32611
18	Mount Sinai Medical Center, Comprehensive Cancer Center	Miami Beach	Florida	United States	33140
19	MD Anderson Cancer Center Orlando	Orlando	Florida	United States	32806
20	Tampa General Hospital	Tampa	Florida	United States	33606
21	Atlanta Cancer Care	Atlanta	Georgia	United States	30005
22	Winship Cancer Institute, Emory University School of Medicine	Atlanta	Georgia	United States	30322
23	Georgia Regents University	Augusta	Georgia	United States	30912
24	Kaiser Permanente Hawaii Moanalua Medical Center	Honolulu	Hawaii	United States	96819
25	Northwestern University Robert H. Lurie Comprehensive Cancer Center	Chicago	Illinois	United States	60611
26	Rush University Medical Center	Chicago	Illinois	United States	60612
27	University of Chicago	Chicago	Illinois	United States	60637
28	North Shore University Health System	Evanston	Illinois	United States	60201
29	Loyola University Medical Center	Maywood	Illinois	United States	60153
30	Covenant Clinic / Iowa Spine and Brain Institute	Waterloo	Iowa	United States	50702
31	University of Kentucky	Lexington	Kentucky	United States	40536-0093
32	Norton Cancer Institute	Louisville	Kentucky	United States	40202
33	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	United States	70809
34	LSU Health Sciences Center, Feist-Weiller Cancer Center	Shreveport	Louisiana	United States	71103
35	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401
36	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21231
37	Center for Cancer and Blood Disorders, PC	Bethesda	Maryland	United States	20817
38	Dana-Farber Cancer Institute and Mass General Hospital	Boston	Massachusetts	United States	02115
39	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
40	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
41	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
42	Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912
43	St. Mary's of Michigan Medical Center/Field Neurosciences Institute	Saginaw	Michigan	United States	48604
44	Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute	Minneapolis	Minnesota	United States	55407
45	Ellis Fischel Cancer Center	Columbia	Missouri	United States	65203
46	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
47	Southeast Nebraska Cancer Center	Lincoln	Nebraska	United States	68510
48	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
49	New Jersey Neuroscience Institute, JFK Medical Center	Edison	New Jersey	United States	08818
50	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
51	Monmouth Medical Center	Long Branch	New Jersey	United States	07740
52	Dent Neurosciences Research Institute	Amherst	New York	United States	14226
53	Montefiore Medical Center	Bronx	New York	United States	10467
54	New York Methodist Hospital	Brooklyn	New York	United States	11215
55	The Long Island Brain Tumor Center at Neurology Surgery, P.C.	Great Neck	New York	United States	11021
56	North Shore University Hospital	Manhasset	New York	United States	11030-3186
57	Columbia University Medical Center - The Neurologic Institute of New York	New York	New York	United States	10032
58	Weill Cornell Medical College	New York	New York	United States	10065
59	University of Rochester Medical Center	Rochester	New York	United States	14642
60	SUNY Upstate Medical University	Syracuse	New York	United States	13210
61	Brain and Spine Surgeons of New York	White Plains	New York	United States	10604
62	The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center	Durham	North Carolina	United States	27710
63	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
64	University of Cincinnati Cancer Institute	Cincinnati	Ohio	United States	45267
65	University Hospitals, Case Medical Center (Cleveland)	Cleveland	Ohio	United States	44106
66	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
67	Ohio State University	Columbus	Ohio	United States	43210
68	Providence Portland Medical Center, Oncology & Hematology Care	Portland	Oregon	United States	97213
69	Pacific Neurosurgical	Portland	Oregon	United States	97227
70	Lehigh Valley Physician Group-Hematology-Oncology Associates	Allentown	Pennsylvania	United States	18103
71	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
72	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
73	West Penn. Allegheny Health System	Pittsburgh	Pennsylvania	United States	15212
74	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15232
75	Medical University of South Carolina - Department of Neuroscience	Charleston	South Carolina	United States	29425
76	University of Tennessee Medical Center - Knoxville	Knoxville	Tennessee	United States	37920
77	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
78	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232
79	Texas Oncology Midtwon	Austin	Texas	United States	78705
80	Baylor Research Institute	Dallas	Texas	United States	75246
81	The Methodist Neurological Institute	Houston	Texas	United States	77030
82	University of Utah Department of Neurosurgery	Salt Lake City	Utah	United States	84112
83	Fletcher Allen Health Care	Burlington	Vermont	United States	05405
84	University of Virginia Healthcare System	Charlottesville	Virginia	United States	22908
85	Swedish Neuroscience Institute	Seattle	Washington	United States	98122
86	University of Washington Medical Center	Seattle	Washington	United States	98195
87	University of Wisconsin Paul P Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792
88	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
89	Prince of Wales Hospital	Randwick	New South Wales	Australia	2031
90	Royal North Shore Hospital	St Leonards	New South Wales	Australia	2605
91	The Crown Princess Mary Cancer Centre, Westmead Hospital	Westmead	New South Wales	Australia	2145
92	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
93	Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited	South Brisbane	Queensland	Australia	4101
94	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
95	Calvary North Adelaide Hospital	North Adelaide	South Australia	Australia	5006
96	Royal Hobart Hospital	Hobart	Tasmania	Australia	7000
97	Launceston General Hospital	Launceston	Tasmania	Australia	7250
98	Monash Medical Centre	Clayton	Victoria	Australia	3199
99	Austin Health	Heidelberg	Victoria	Australia	3084
100	Epworth Healthcare	Richmond	Victoria	Australia	3121
101	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	06008
102	Liverpool Hospital	Liverpool		Australia	2107
103	Medical University Innsbruck, Dept of Neurology, Anichstrabe 35	Innsbruck		Austria	6020
104	Medizinische Universität Wien, Innere Medizin I, Onkologie	Vienna		Austria	1090
105	Universitair Ziekenhuis Antwerpen	Edegem	Antwerp	Belgium	2650
106	ZNA Middelheim	Antwerpen		Belgium	B-2020
107	Ghent University Hospital	Ghent		Belgium	9000
108	Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica	Porto Alegre	Rio Grande Do Sul	Brazil	90840-440
109	Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho	Jaú	São Paulo	Brazil	17210-120
110	Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base	São José do Rio Preto	São Paulo	Brazil	15090-000
111	Instituto Nacional do Cancer (INCA)	Rio de Janeiro		Brazil	20231-050
112	Hospital Albert Einstein	Sao Paulo		Brazil	05652-900
113	Instituto do Câncer do Estado de São Paulo - ICESP	São Paulo		Brazil	01246-000
114	Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José	São Paulo		Brazil	01321-001
115	Hospital A C Camargo	São Paulo		Brazil	01509-900
116	Foothills Hospital Medical Centre	Calgary	Alberta	Canada	T3J 5N6
117	British Columbia Cancer Agency, Vancouver Clinic	Vancouver	British Columbia	Canada	V5Z 4E6
118	BC Cancer Agency - Vancouver Island Centre	Victoria	British Columbia	Canada	V8X 4V6
119	University of Manitoba-Cancer Care Manitoba	Winnipeg	Manitoba	Canada	R3E0V9
120	QEII Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 1V7
121	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
122	London Regional Cancer Program, London Health Sciences Centre	London	Ontario	Canada	N6A 4L6
123	Ottawa Hospital, Regional Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6
124	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N3M5
125	Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame	Montreal	Quebec	Canada	H2L 4M1
126	Montreal Neurological Institute and Hospital	Montreal	Quebec	Canada	H3A 2B4
127	CHUS Hôpital Fleurimont	Shenbrooke	Quebec	Canada	J1H5N4
128	CHUQ L'Hotel Dieu de Qujebec	Quebec		Canada	G1R 2J6
129	Fundacion Santa Fe	Bogota	Bogota D.C	Colombia	000
130	Hospital Ceske Budejovice	Ceske Budejovice		Czechia	370 01
131	Umiversity Hospital (Fakultni Nemocnice)	Prague		Czechia	150 06
132	Hospital Na Homolce	Prague		Czechia	150 30
133	Multiscan s.r.o.	Praha 5		Czechia	155-00
134	Masaryk´s Hospital Usti nad Labem	Usti nad Labem		Czechia	401-13
135	Institut de Cancerologie de I'Quest-Paul Papin	Angers		France	49933
136	Institute Bergonie	Bordeaux		France	33076
137	Centre Leon Berard de Lyon	Lyon		France	69373
138	ICM Val d'Aurel Montpellier	Montpellier		France	342298
139	Institut de Cancerologie de L'Quest-Center Rane Gauducheau	Nantes		France	44805
140	Service de Neurologie-GH	Paris		France	75013
141	Centre Eugene Marquis	Rennes		France	35042
142	Institut de Cancerologie de l'ouest-Center Rene Gauducheau	St Herblain		France	44805
143	Institut Gustave Roussy	Villejuif		France	94805
144	Klinik und Poliklinik fur Neurologie der Universitat Regensburg	Regensburg	Bavaria	Germany	93053
145	Strahlenklinik Universitatsklinikum Erlangen	Erlangen		Germany	D-91054
146	Dr. Senchkenbergisches Institut fur Neuroonkologie	Frankfurt		Germany	D-60528
147	University Hospital Hamburg Kopf und Neurozentrum	Hamburg		Germany	20246
148	Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672	Heidelberg		Germany	69120
149	University Medical Centre	Kiel		Germany	24105
150	Universitaetsklinikum Muenster	Muenster		Germany	48149
151	LMU Munich	Munich		Germany	D-81377
152	NNA	Athens	Attiki	Greece	11521
153	"HYGEIA" Hospital	Marousi	District Of Attica	Greece	151 23
154	Országos Onkológiai Intézet Sugárterápiás Osztály	Budapest		Hungary	1122
155	Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet	Debrecen		Hungary	4032
156	Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály	Miskolc		Hungary	3526
157	Pécsi Tudományegyetem Általános Orvostudományi Kar	Pécs		Hungary	7624
158	Szegedi Tudományegyetem Onkoterápiás Klinika	Szeged		Hungary	6720
159	Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt	Szombathely		Hungary	9700
160	City Cancer Centre, Vijayawada	Vijayawada	Andhra Pradesh	India	520002
161	HCG - Bangalore Institute of Oncology, Bangalore	Bengaluru	Karnataka	India	560027
162	Amrita Institute of Medical Sciences and Research Centre, Kochi	Kochi	Kerala	India	682 026
163	Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram	Thiruvananthapuram	Kerala	India	695 011
164	Marathwada Regional Cancer Centre and Research Institute - Government	Aurangabad	Maharashtra	India	431001
165	Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute	Andheri-West	Mumbai	India	400 053
166	Tata Memorial Hospital , Mumbai	Parel	Mumbai	India	400012
167	Indraprastha Apollo Hospital, New Delhi	Jasola Viha	New Delhi	India	110076
168	Sahyadri Hospitals Limited	Erandauame	Pune	India	411004
169	Dr. Rai Memorial Medical Centre, Chennai	Chennai	Tamil Nadu	India	600018
170	HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi	Delhi		India	110092
171	Soroka University M.C.	Beer-Sheva		Israel	84101
172	Rambam Health Care Campus	Haifa		Israel	3109601
173	Hadassah Medical Center	Jerusalem		Israel	91120
174	SHEBA Medical Center	Tel Hashomer		Israel	52126
175	Tel-Aviv Sourasky Medical Center	Tel-Aviv		Israel	64239
176	UO Oncologie Medica Dipartimento Oncologico	Bologna		Italy	40139
177	Fondazione IRCCS Instituto Neurologico Carlo Besta	Milano		Italy	20133
178	Sacred Heart Catholic University	Rome		Italy	00168
179	Universita e AO Citta delia Scienza, Universita Di Torino	Torino		Italy	10126
180	Grupo Médico Camino S.C.	Mexico	D.F	Mexico	03310
181	Hospital Civil de Guadalajara "Fray Antonio Alcalde"	Guadalajara	Jalisco	Mexico	34000
182	Ensayos Clínicos y Medicina de Alta Especialidad, S.C.	Culiacán	Sinaloa	Mexico	80020
183	Servicios Medicos de Investigacion Clinica Sc	Durango		Mexico	34000
184	Hospital Central "Ignacio Morones Prieto"	San Luis Potosí		Mexico	78240
185	Medisch Centrum Haaglanden	The Hague	Zuid Holland	Netherlands	2512 VA
186	VUMC	Amsterdam		Netherlands	1081HV
187	Radboud University Nijmegen Medical Center	Nijmegen		Netherlands	6525 GA
188	Christchurch Hospital	Christchurch Central	Christchurch	New Zealand	8011
189	Palmerston North Hospital	Roslyn	Palmerston North	New Zealand	4414
190	Waikato Hospital, Regional Cancer Centre	Hamilton	Waikato District	New Zealand	3240
191	Waikato Hospital, Regional Cancer Center	Hamilton	Waikato Distric	New Zealand	3240
192	Hospital Almanzor Aguinaga Asenjo	Chiclayo		Peru
193	Instituto Oncologico Miraflores	Lima		Peru	Lima 18
194	Clinica Anglo Americana	Lima		Peru	Lima 27
195	Clinica Ricardo Palma	Lima		Peru	Lima 27
196	Oncosalud	Lima		Peru	Lima 41
197	Institut Catala d Oncologia	LaHospitalet De Lubregat	Catalonia	Spain	08908
198	Dra. Sonia Del Barco Berron, ICO Girona Avda,	Franca	Girona	Spain	17007
199	Hospital Clinic	Barcelona		Spain	8036
200	ICO Badalona-Hospital Germans Trias i Pujol	Barcelonia		Spain	08916
201	Hospital 12 de Octubre	Madrid		Spain	28041
202	Kantonsspital Aarau Medizinische Onkologie Tellstrasse	Aarau	AG	Switzerland	5001
203	CHUV, Centre Hospitalier Universitaire Vaudois	Lausanne	VD	Switzerland	1011
204	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona		Switzerland	6500
205	Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse	Bern		Switzerland	3010
206	Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie	Geneva		Switzerland	1211
207	Brain Tumor Center, University Hospital Zurich	Zurich		Switzerland	8091
208	National Cheng Kung University Hospital	Tainan City	Bei District	Taiwan	704
209	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
210	Chang Gung Memorial Hospital Linkou Branch	Taichung		Taiwan	40705
211	Taichung Veterans General Hospital	Taichung		Taiwan	40705
212	Chi Mei Medical Center	Tainan City - Yongkang District		Taiwan	710
213	Tri-Service General Hospital	Taipei city - Neihu District		Taiwan	00114
214	Siriraj Hospital	Bangkoknoi	Bangkok	Thailand	10700
215	King Chulalongkorn Memorial Hospital	Patumwan	Bankok	Thailand	10330
216	Maharaj Nakorn Chiang Mai Hospital	Amphoe Muang	Chiang Mai	Thailand	50200
217	Songkhlanagarind Hospital	Hat Yai	Songkla	Thailand	90110
218	Royal Marsden NHS Foundation Trust	Sutton	Surrey	United Kingdom	SM2 5PT
219	The Bristol Haematology and Oncology Centre	Bristol		United Kingdom	BS2 8ED
220	Edinburgh Cancer Centre Western General Hospital	Edinburgh		United Kingdom	EH4 2XU
221	Beatson West of Scotland Cancer Centrel	Glasgow		United Kingdom	G12 0NY
222	Guy's and St Thomas' NHS, Westminister Bridge Road	London		United Kingdom	SE17EH
223	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1PB

Sponsors and Collaborators

• Celldex Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celldex Therapeutics
• ClinicalTrials.gov Identifier: NCT01480479
• Other Study ID Numbers: CDX110-04
• First Posted: Nov 29, 2011
• Last Update Posted: Jan 16, 2018
• Last Verified: Apr 1, 2017

• Keywords provided by Celldex Therapeutics: EGFRvIII; Glioblastoma; Small cell; Giant cell; Gliosarcoma; oligodendroglial; Brain Cancer; Brain Tumor; radiotherapy; chemoradiation; Tumor; temozolomide; EGFR variant III
• Additional relevant MeSH terms: Glioblastoma; Gliosarcoma; Temozolomide; Molgramostim; Rindopepimut; Sargramostim

Study Results

No Results Posted as of Jan 16, 2018