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IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sunitinib
GM-CSF
Cyclophosphamide
IMA901
Sponsored by
Immatics Biotechnologies GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Metastatic Renal Cell Carcinoma, First line, Eligible for sunitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged at least 18 years.
  2. HLA type: HLA-A*02-positive
  3. Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required.
  4. Measurable and/or non-measurable tumor lesions as per RECIST 1.1
  5. Patients who are candidates for a first-line therapy with sunitinib.

  6. Favorable or intermediate risk according to the 6-score risk criteria in patients treated with VEGF-targeted agents according to Heng [Heng et al. 2009]. The patient has a favorable risk if none, or intermediate risk if one or two of the following criteria apply (if three or more criteria apply the patient is not eligible):

    1. Hemoglobin < LLN,
    2. Serum corrected calcium > ULN,
    3. Karnofsky performance status < 80%,
    4. Time from initial diagnosis to initiation of therapy < 1 year,
    5. Absolute neutrophil count > ULN,
    6. Platelets > ULN.
  7. Able to understand the nature of the study and give written informed consent.
  8. Willingness and ability to comply with the study protocol for the duration of the study.
  9. Female patients who are post menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or practice a medically acceptable method of birth control.
  10. Male patients willing to use contraception (upon study entry and during the course of the study or have undergone vasectomy.

Exclusion Criteria:

  1. Prior systemic therapy for metastatic disease. (Note: prior adjuvant treatment for non-metastatic disease is allowed, however adjuvant therapy must have been stopped ≥ 1 year before Visit C).
  2. History of or current brain metastases.
  3. Abnormal ≥ CTC Grade 3 laboratory values for hematology (Hb, WBC, neutrophils, lymphocytes, platelets), liver (serum bilirubin, ALAT or ASAT) and renal function (serum creatinine).
  4. Metastatic second malignancy.
  5. Localized second malignancy expected to influence the patient's life span.
  6. Patients with a history or evidence of systemic autoimmune disease, e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome.
  7. Known active hepatitis B or C infection.
  8. Known HIV infection.
  9. Active infections requiring oral or intravenous antibiotics.
  10. Any other known infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patients' blood or tissue.
  11. Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start.

  12. Serious intercurrent illness, which according to the investigator, poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following:

    • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension; clinically significant cardiac arrhythmia, clinically significant QT-prolongation),
    • New York Heart Association class III-IV congestive heart failure,
    • Symptomatic peripheral vascular disease,
    • Severe pulmonary dysfunction,
    • Psychiatric illness or social situation that would preclude study compliance.

  13. Less than 12 months since any of the following:

    • Myocardial infarction,
    • Severe or unstable angina,
    • Coronary or peripheral artery bypass graft,
    • Cerebrovascular event incl. transient ischemic attack,
    • Pulmonary embolism / deep vein thrombosis (DVT).
  14. Pregnancy or breastfeeding.
  15. Any condition which in the judgment of the investigator would place the patient at undue risk or interfere with the results of the study.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • Kaiser Permanente Oncology Hematology Clinic
  • Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
  • M.D. Anderson Cancer Center
  • The University of Chicago Medicine
  • North Central Cancer Treatment Group, Illinois Cancer Care
  • IU Simon Cancer Center
  • Weinberg Cancer Institute at Franklin Hospital
  • Karmanos Cancer Institute
  • Clinical Research Alliance
  • University of Cincinnati
  • Cleveland Clinic Taussig Cancer Institute
  • UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology
  • Vanderbilt-Ingram Cancer Center
  • South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care
  • Seattle Cancer Care Alliance
  • Hôpital Saint André
  • Centre Francois Baclesse, Comite Urologie-Gynecologie
  • CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire
  • Hospital Européen Georges Pompidou, Service d'oncologie medicale
  • Centre Rene Gauducheau, Service d'oncologie medicale
  • Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz
  • Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH
  • Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn
  • Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)
  • Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover
  • Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie
  • Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig
  • Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München
  • Urologische Klinik Dr. Castringius, München-Planegg
  • Klinikum St. Elisabeth Straubing GmbH
  • Klinik für Urologie, Universitätsklinikum Tübingen
  • Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm
  • Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie
  • Péterfy Utcai Hospital, Urology department
  • Semmelweis University, Urology Clinic
  • Urology Department, Bajcsy-Zsilinszky Hospital
  • Uzsoki Utcai Hospital, Oncoradiology Center
  • University of Debrecen, Faculty of Medicine, Institute of Oncology
  • University of Debrecen, Faculty of Medicine, Urology Clinic
  • Kenézy Hospital, Urology Department
  • Oncology Centre, Markhot Ferenc Training Hospital and Clinic
  • Pándy Kálmán County Hospital, Oncology and Radiotherapy Center
  • Urology department, BAZ County Hospital
  • Urology Clinic, University of Pécs
  • Oncology Therapy Clinic, University of Szeged
  • County Oncology Centre, Hetényi Géza Hospital
  • Oncology Department, Zala County Hospital
  • Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica
  • Centro di riferimento Oncologico di Aviano
  • Medical Oncology Unit, Policlinico Sant'Orsola Malpighi
  • Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia
  • Dipartimento di Oncologia, IRCCS Fondazione
  • Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia
  • Oncologia Medica, "Ospedale Infermi"
  • Ospedale S.S Annunziata Sasari
  • IRCC-Istituto di Ricerca e Cura del Cancro
  • University Medical Center St. Radboud Centraal, Department of Urology
  • University Hospital, UOS - Radiumhospital
  • Białostockie Centrum Onkologii
  • Prof. Franciszek Łukaszczyk Oncology Center
  • Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna
  • Wojewódzki Szpital Zespolony, Oncology Department
  • Uniwersyteckie Centrum Kliniczne, Klinika Urologii
  • Chemotherapy Department Center of Oncology of the Lublin Region
  • Olsztyński Oncology Center "KOPERNIK"
  • Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic
  • Private Outpatient Clinic MRUKMED
  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
  • Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic
  • Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
  • Urology and Urological Oncology Department and Clinic
  • Fundeni Clinical Institute
  • "Prof. Dr. Ioan Chiricuta" Oncology Institute
  • "Prof. Dr. Ioan Chiricuta" Oncology Institute
  • Medisprof SRL
  • SC Oncolab SRL
  • Emergency Clinical County Hospital Oradea
  • Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department
  • State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"
  • Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
  • Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"
  • Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"
  • Moscow Hertsen Scientific Research Oncological Institute
  • State Institution "City Clinical Hospital NO20"
  • Orenburg Regional Clinical Oncological Dispensary
  • State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"
  • State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"
  • Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"
  • State Institution of Healthcare "Leningrad Regional Oncological Dispensary"
  • Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"
  • Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"
  • Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"
  • Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"
  • Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)
  • State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"
  • Royal Bournemouth Hospital
  • Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center
  • Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital
  • Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology
  • Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology
  • ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital
  • CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital
  • Postgraduate Medical School, University of Surrey
  • South West Wales Cancer Institute, Singleton Hospital, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sunitinib

IMA901 plus GM-CSF added to sunitinib after single dose of cy

Arm Description

Sunitib as Standard therapy per Label.

After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant after a single dose of cyclophosphamide will be applied for a period of 4 months while continuing treatment with sunitinib

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Overall survival in biomarker-defined subgroup
Progression-free survival
Best tumor response
Safety and tolerability
Cellular immunomonitoring

Full Information

First Posted
December 22, 2010
Last Updated
October 4, 2017
Sponsor
Immatics Biotechnologies GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01265901
Brief Title
IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
Official Title
A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immatics Biotechnologies GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib. Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.
Detailed Description
This is a multicenter, open-label, randomized phase III study to investigate whether therapeutic vaccination with IMA901, a mult-peptide cancer vaccine (TUMAP), can prolong overall survival in patients with metastatic and/or locally advanced RCC when added to standard first-line therapy with sunitinib (primary endpoint). Secondary endpoints include a subgroup analysis of overall survival in patients who are positive for a prospectively defined primary biomarker signature (identified as being predictive for improved clinical outcome in IMA901-vaccinated patients in the previous phase II study), progression-free survival (PFS), best overall response, cellular immunomonitoring in a subset of patients, and safety. Safety analysis will be based on adverse events (AEs), physical examinations, vital signs, hematology, clinical chemistry, urinalysis and ECG changes. Further endpoints include subgroup analyses of overall survival in patients who are positive for further prospectively defined biomarkers (identified in the previous phase II study), and exploratory screening of new biomarkers (to be investigated in patients' blood and paraffin sections from tumor tissue) to predict better clinical outcome as response to vaccination with IMA901. Biomarker sets will not be used for patient selection in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
Metastatic Renal Cell Carcinoma, First line, Eligible for sunitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib
Arm Type
Active Comparator
Arm Description
Sunitib as Standard therapy per Label.
Arm Title
IMA901 plus GM-CSF added to sunitinib after single dose of cy
Arm Type
Experimental
Arm Description
After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant after a single dose of cyclophosphamide will be applied for a period of 4 months while continuing treatment with sunitinib
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
As per label.
Intervention Type
Biological
Intervention Name(s)
GM-CSF
Other Intervention Name(s)
Granulocyte macrophage-colony stimulating factor, Leukine, Sargramostim
Intervention Description
Intradermal injection of GM-CSF as adjuvant.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan (EU name), Cytoxan (US name)
Intervention Description
One single low-dose i.v. infusion prior to the first vaccination
Intervention Type
Drug
Intervention Name(s)
IMA901
Other Intervention Name(s)
IMA901 Vaccine
Intervention Description
Intradermal vaccinations with IMA901 vaccine.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2015 (estimated)
Secondary Outcome Measure Information:
Title
Overall survival in biomarker-defined subgroup
Time Frame
2015 (estimated)
Title
Progression-free survival
Time Frame
2014 (estimated)
Title
Best tumor response
Time Frame
2014 (estimated)
Title
Safety and tolerability
Time Frame
continuously
Title
Cellular immunomonitoring
Time Frame
2014 (estimated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged at least 18 years. HLA type: HLA-A*02-positive Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required. Measurable and/or non-measurable tumor lesions as per RECIST 1.1 Patients who are candidates for a first-line therapy with sunitinib. Favorable or intermediate risk according to the 6-score risk criteria in patients treated with VEGF-targeted agents according to Heng [Heng et al. 2009]. The patient has a favorable risk if none, or intermediate risk if one or two of the following criteria apply (if three or more criteria apply the patient is not eligible): Hemoglobin < LLN, Serum corrected calcium > ULN, Karnofsky performance status < 80%, Time from initial diagnosis to initiation of therapy < 1 year, Absolute neutrophil count > ULN, Platelets > ULN. Able to understand the nature of the study and give written informed consent. Willingness and ability to comply with the study protocol for the duration of the study. Female patients who are post menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or practice a medically acceptable method of birth control. Male patients willing to use contraception (upon study entry and during the course of the study or have undergone vasectomy. Exclusion Criteria: Prior systemic therapy for metastatic disease. (Note: prior adjuvant treatment for non-metastatic disease is allowed, however adjuvant therapy must have been stopped ≥ 1 year before Visit C). History of or current brain metastases. Abnormal ≥ CTC Grade 3 laboratory values for hematology (Hb, WBC, neutrophils, lymphocytes, platelets), liver (serum bilirubin, ALAT or ASAT) and renal function (serum creatinine). Metastatic second malignancy. Localized second malignancy expected to influence the patient's life span. Patients with a history or evidence of systemic autoimmune disease, e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome. Known active hepatitis B or C infection. Known HIV infection. Active infections requiring oral or intravenous antibiotics. Any other known infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patients' blood or tissue. Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start. Serious intercurrent illness, which according to the investigator, poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following: Clinically significant cardiovascular disease (e.g., uncontrolled hypertension; clinically significant cardiac arrhythmia, clinically significant QT-prolongation), New York Heart Association class III-IV congestive heart failure, Symptomatic peripheral vascular disease, Severe pulmonary dysfunction, Psychiatric illness or social situation that would preclude study compliance. Less than 12 months since any of the following: Myocardial infarction, Severe or unstable angina, Coronary or peripheral artery bypass graft, Cerebrovascular event incl. transient ischemic attack, Pulmonary embolism / deep vein thrombosis (DVT). Pregnancy or breastfeeding. Any condition which in the judgment of the investigator would place the patient at undue risk or interfere with the results of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Rini, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tim Eisen, MD
Organizational Affiliation
Addenbrooke's Hospital University of Cambridge, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kaiser Permanente Oncology Hematology Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
North Central Cancer Treatment Group, Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7822
Country
United States
Facility Name
IU Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Weinberg Cancer Institute at Franklin Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Francois Baclesse, Comite Urologie-Gynecologie
City
Caen Cedex
ZIP/Postal Code
14076
Country
France
Facility Name
CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire
City
Clermont Ferrand Cedex
ZIP/Postal Code
63003
Country
France
Facility Name
Hospital Européen Georges Pompidou, Service d'oncologie medicale
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Rene Gauducheau, Service d'oncologie medicale
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Urologische Klinik Dr. Castringius, München-Planegg
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
Klinikum St. Elisabeth Straubing GmbH
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Facility Name
Klinik für Urologie, Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Péterfy Utcai Hospital, Urology department
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Semmelweis University, Urology Clinic
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Urology Department, Bajcsy-Zsilinszky Hospital
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Uzsoki Utcai Hospital, Oncoradiology Center
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
University of Debrecen, Faculty of Medicine, Institute of Oncology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
University of Debrecen, Faculty of Medicine, Urology Clinic
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Kenézy Hospital, Urology Department
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Oncology Centre, Markhot Ferenc Training Hospital and Clinic
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Pándy Kálmán County Hospital, Oncology and Radiotherapy Center
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Urology department, BAZ County Hospital
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Urology Clinic, University of Pécs
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Oncology Therapy Clinic, University of Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
County Oncology Centre, Hetényi Géza Hospital
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Oncology Department, Zala County Hospital
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Centro di riferimento Oncologico di Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Medical Oncology Unit, Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Dipartimento di Oncologia, IRCCS Fondazione
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Oncologia Medica, "Ospedale Infermi"
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Ospedale S.S Annunziata Sasari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
IRCC-Istituto di Ricerca e Cura del Cancro
City
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
University Medical Center St. Radboud Centraal, Department of Urology
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
University Hospital, UOS - Radiumhospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Białostockie Centrum Onkologii
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Prof. Franciszek Łukaszczyk Oncology Center
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna
City
Dobra
ZIP/Postal Code
72-003
Country
Poland
Facility Name
Wojewódzki Szpital Zespolony, Oncology Department
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Urologii
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Chemotherapy Department Center of Oncology of the Lublin Region
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Olsztyński Oncology Center "KOPERNIK"
City
Olsztyn
ZIP/Postal Code
10-513
Country
Poland
Facility Name
Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Private Outpatient Clinic MRUKMED
City
Rzeszów
ZIP/Postal Code
35-242
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
City
Warsaw
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Urology and Urological Oncology Department and Clinic
City
Warsaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
"Prof. Dr. Ioan Chiricuta" Oncology Institute
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
"Prof. Dr. Ioan Chiricuta" Oncology Institute
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
SC Oncolab SRL
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
Emergency Clinical County Hospital Oradea
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department
City
Targu-Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Moscow Hertsen Scientific Research Oncological Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
State Institution "City Clinical Hospital NO20"
City
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Oncological Dispensary
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"
City
Saratov
ZIP/Postal Code
410004
Country
Russian Federation
Facility Name
State Institution of Healthcare "Leningrad Regional Oncological Dispensary"
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Postgraduate Medical School, University of Surrey
City
Surrey
ZIP/Postal Code
GU2 7WG
Country
United Kingdom
Facility Name
South West Wales Cancer Institute, Singleton Hospital, School of Medicine
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27720136
Citation
Rini BI, Stenzl A, Zdrojowy R, Kogan M, Shkolnik M, Oudard S, Weikert S, Bracarda S, Crabb SJ, Bedke J, Ludwig J, Maurer D, Mendrzyk R, Wagner C, Mahr A, Fritsche J, Weinschenk T, Walter S, Kirner A, Singh-Jasuja H, Reinhardt C, Eisen T. IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Nov;17(11):1599-1611. doi: 10.1016/S1470-2045(16)30408-9. Epub 2016 Oct 3.
Results Reference
derived

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IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma

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