IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
NCT ID: NCT01265901
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
339 participants
INTERVENTIONAL
2010-12-31
2015-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sunitinib
Sunitib as Standard therapy per Label.
Sunitinib
As per label.
IMA901 plus GM-CSF added to sunitinib after single dose of cy
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
Sunitinib
As per label.
GM-CSF
Intradermal injection of GM-CSF as adjuvant.
Cyclophosphamide
One single low-dose i.v. infusion prior to the first vaccination
IMA901
Intradermal vaccinations with IMA901 vaccine.
Interventions
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Sunitinib
As per label.
GM-CSF
Intradermal injection of GM-CSF as adjuvant.
Cyclophosphamide
One single low-dose i.v. infusion prior to the first vaccination
IMA901
Intradermal vaccinations with IMA901 vaccine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Immatics Biotechnologies GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Rini, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute
Tim Eisen, MD
Role: PRINCIPAL_INVESTIGATOR
Addenbrooke's Hospital University of Cambridge, UK
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Kaiser Permanente Oncology Hematology Clinic
Denver, Colorado, United States
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
M.D. Anderson Cancer Center
Orlando, Florida, United States
The University of Chicago Medicine
Chicago, Illinois, United States
North Central Cancer Treatment Group, Illinois Cancer Care
Peoria, Illinois, United States
IU Simon Cancer Center
Indianapolis, Indiana, United States
Weinberg Cancer Institute at Franklin Hospital
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Clinical Research Alliance
Lake Success, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care
San Antonio, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Hôpital Saint André
Bordeaux, , France
Centre Francois Baclesse, Comite Urologie-Gynecologie
Caen, , France
CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire
Clermont-Ferrand, , France
Hospital Européen Georges Pompidou, Service d'oncologie medicale
Paris, , France
Centre Rene Gauducheau, Service d'oncologie medicale
Saint-Herblain, , France
Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz
Berlin, , Germany
Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH
Bochum, , Germany
Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)
Essen, , Germany
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover
Hanover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie
Heidelberg, , Germany
Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig
Leipzig, , Germany
Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München
Munich, , Germany
Urologische Klinik Dr. Castringius, München-Planegg
Planegg, , Germany
Klinikum St. Elisabeth Straubing GmbH
Straubing, , Germany
Klinik für Urologie, Universitätsklinikum Tübingen
Tübingen, , Germany
Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm
Ulm, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie
Villingen-Schwenningen, , Germany
Péterfy Utcai Hospital, Urology department
Budapest, , Hungary
Semmelweis University, Urology Clinic
Budapest, , Hungary
Urology Department, Bajcsy-Zsilinszky Hospital
Budapest, , Hungary
Uzsoki Utcai Hospital, Oncoradiology Center
Budapest, , Hungary
University of Debrecen, Faculty of Medicine, Institute of Oncology
Debrecen, , Hungary
University of Debrecen, Faculty of Medicine, Urology Clinic
Debrecen, , Hungary
Kenézy Hospital, Urology Department
Debrecen, , Hungary
Oncology Centre, Markhot Ferenc Training Hospital and Clinic
Eger, , Hungary
Pándy Kálmán County Hospital, Oncology and Radiotherapy Center
Gyula, , Hungary
Urology department, BAZ County Hospital
Miskolc, , Hungary
Urology Clinic, University of Pécs
Pécs, , Hungary
Oncology Therapy Clinic, University of Szeged
Szeged, , Hungary
County Oncology Centre, Hetényi Géza Hospital
Szolnok, , Hungary
Oncology Department, Zala County Hospital
Zalaegerszeg, , Hungary
Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica
Arezzo, , Italy
Centro di riferimento Oncologico di Aviano
Aviano, , Italy
Medical Oncology Unit, Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia
Modena, , Italy
Dipartimento di Oncologia, IRCCS Fondazione
Pavia, , Italy
Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia
Reggio Emilia, , Italy
Oncologia Medica, "Ospedale Infermi"
Rimini, , Italy
Ospedale S.S Annunziata Sasari
Sassari, , Italy
IRCC-Istituto di Ricerca e Cura del Cancro
Torino, , Italy
University Medical Center St. Radboud Centraal, Department of Urology
Nijmegen, , Netherlands
University Hospital, UOS - Radiumhospital
Oslo, , Norway
Białostockie Centrum Onkologii
Bialystok, , Poland
Prof. Franciszek Łukaszczyk Oncology Center
Bydgoszcz, , Poland
Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna
Dobra, , Poland
Wojewódzki Szpital Zespolony, Oncology Department
Elblag, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Urologii
Gdansk, , Poland
Chemotherapy Department Center of Oncology of the Lublin Region
Lublin, , Poland
Olsztyński Oncology Center "KOPERNIK"
Olsztyn, , Poland
Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic
Poznan, , Poland
Private Outpatient Clinic MRUKMED
Rzeszów, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, , Poland
Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic
Warsaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
Warsaw, , Poland
Urology and Urological Oncology Department and Clinic
Warsaw, , Poland
Fundeni Clinical Institute
Bucharest, , Romania
"Prof. Dr. Ioan Chiricuta" Oncology Institute
Cluj-Napoca, , Romania
Medisprof SRL
Cluj-Napoca, , Romania
SC Oncolab SRL
Craiova, , Romania
Emergency Clinical County Hospital Oradea
Oradea, , Romania
Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department
Târgu Mureş, , Romania
State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"
Chelyabinsk, , Russia
Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
Kazan', , Russia
Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"
Moscow, , Russia
Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"
Moscow, , Russia
Moscow Hertsen Scientific Research Oncological Institute
Moscow, , Russia
State Institution "City Clinical Hospital NO20"
Moscow, , Russia
Orenburg Regional Clinical Oncological Dispensary
Orenburg, , Russia
State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"
Rostov-on-Don, , Russia
State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"
Ryazan, , Russia
State Institution of Healthcare "Leningrad Regional Oncological Dispensary"
Saint Petersburg, , Russia
Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"
Saint Petersburg, , Russia
Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"
Saint Petersburg, , Russia
Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"
Saint Petersburg, , Russia
Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"
Saint Petersburg, , Russia
Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)
Saint Petersburg, , Russia
Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"
Saratov, , Russia
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"
Yaroslavl, , Russia
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center
Cambridge, , United Kingdom
Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital
Leeds, , United Kingdom
Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology
Manchester, , United Kingdom
Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology
Oxford, , United Kingdom
ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital
Preston, , United Kingdom
CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital
Southampton, , United Kingdom
Postgraduate Medical School, University of Surrey
Surrey, , United Kingdom
South West Wales Cancer Institute, Singleton Hospital, School of Medicine
Swansea, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-022459-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMA901-301
Identifier Type: -
Identifier Source: org_study_id