IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
- Conditions
- Metastatic Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT01265901
- Lead Sponsor
- Immatics Biotechnologies GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 339
-
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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMA901 plus GM-CSF added to sunitinib after single dose of cy GM-CSF 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 Sunitinib Sunitib as Standard therapy per Label. IMA901 plus GM-CSF added to sunitinib after single dose of cy Sunitinib 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 IMA901 plus GM-CSF added to sunitinib after single dose of cy Cyclophosphamide 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 IMA901 plus GM-CSF added to sunitinib after single dose of cy IMA901 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
- Primary Outcome Measures
Name Time Method Overall survival 2015 (estimated)
- Secondary Outcome Measures
Name Time Method Overall survival in biomarker-defined subgroup 2015 (estimated) Best tumor response 2014 (estimated) Progression-free survival 2014 (estimated) Safety and tolerability continuously Cellular immunomonitoring 2014 (estimated)
Trial Locations
- Locations (105)
Medisprof SRL
🇷🇴Cluj-Napoca, Romania
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
🇺🇸Washington, D.C., District of Columbia, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Hôpital Saint André
🇫🇷Bordeaux, France
North Central Cancer Treatment Group, Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
Semmelweis University, Urology Clinic
🇭🇺Budapest, Hungary
SC Oncolab SRL
🇷🇴Craiova, Romania
Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic
🇵🇱Warsaw, Poland
Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department
🇷🇴Targu-Mures, Romania
State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"
🇷🇺Ryazan, Russian Federation
Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology
🇬🇧Oxford, United Kingdom
State Institution "City Clinical Hospital NO20"
🇷🇺Moscow, Russian Federation
Urology and Urological Oncology Department and Clinic
🇵🇱Warsaw, Poland
"Prof. Dr. Ioan Chiricuta" Oncology Institute
🇷🇴Cluj-Napoca, Romania
Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)
🇷🇺St. Petersburg, Russian Federation
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
Postgraduate Medical School, University of Surrey
🇬🇧Surrey, United Kingdom
Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"
🇷🇺Moscow, Russian Federation
State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"
🇷🇺Rostov-on-Don, Russian Federation
Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center
🇬🇧Cambridge, United Kingdom
South West Wales Cancer Institute, Singleton Hospital, School of Medicine
🇬🇧Swansea, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital
🇬🇧Southampton, United Kingdom
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute
🇺🇸Los Angeles, California, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
IU Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Weinberg Cancer Institute at Franklin Hospital
🇺🇸Baltimore, Maryland, 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
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Kaiser Permanente Oncology Hematology Clinic
🇺🇸Denver, Colorado, United States
ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital
🇬🇧Preston, United Kingdom
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
Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Urology Department, Bajcsy-Zsilinszky Hospital
🇭🇺Budapest, Hungary
M.D. Anderson Cancer Center
🇺🇸Orlando, Florida, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Clinical Research Alliance
🇺🇸Lake Success, New York, United States
South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care
🇺🇸San Antonio, Texas, United States
Centre Francois Baclesse, Comite Urologie-Gynecologie
🇫🇷Caen Cedex, France
CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire
🇫🇷Clermont Ferrand Cedex, 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
Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH
🇩🇪Bochum, Germany
Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)
🇩🇪Essen, Germany
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie
🇩🇪Heidelberg, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie
🇩🇪Villingen-Schwenningen, Germany
Péterfy Utcai Hospital, Urology department
🇭🇺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
County Oncology Centre, Hetényi Géza Hospital
🇭🇺Szolnok, Hungary
Urology department, BAZ County Hospital
🇭🇺Miskolc, Hungary
Urology Clinic, University of Pécs
🇭🇺Pécs, Hungary
Oncology Therapy Clinic, University of Szeged
🇭🇺Szeged, Hungary
Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica
🇮🇹Arezzo, Italy
Oncology Department, Zala County Hospital
🇭🇺Zalaegerszeg, Hungary
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
🇵🇱Białystok, Poland
Prof. Franciszek Łukaszczyk Oncology Center
🇵🇱Bydgoszcz, Poland
Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna
🇵🇱Dobra, Poland
Wojewódzki Szpital Zespolony, Oncology Department
🇵🇱Elbląg, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Urologii
🇵🇱Gdańsk, Poland
Chemotherapy Department Center of Oncology of the Lublin Region
🇵🇱Lublin, Poland
Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic
🇵🇱Poznań, Poland
Olsztyński Oncology Center "KOPERNIK"
🇵🇱Olsztyn, Poland
Private Outpatient Clinic MRUKMED
🇵🇱Rzeszów, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
🇵🇱Szczecin, Poland
State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"
🇷🇺Chelyabinsk, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
🇷🇺Kazan, Russian Federation
Orenburg Regional Clinical Oncological Dispensary
🇷🇺Orenburg, Russian Federation
Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"
🇷🇺St. Petersburg, Russian Federation
Moscow Hertsen Scientific Research Oncological Institute
🇷🇺Moscow, Russian Federation
Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
🇵🇱Warsaw, Poland
Fundeni Clinical Institute
🇷🇴Bucharest, Romania
Emergency Clinical County Hospital Oradea
🇷🇴Oradea, Romania
State Institution of Healthcare "Leningrad Regional Oncological Dispensary"
🇷🇺St. Petersburg, Russian Federation
Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"
🇷🇺St. Petersburg, Russian Federation
Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"
🇷🇺St. Petersburg, Russian Federation
Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"
🇷🇺Saratov, Russian Federation
Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"
🇷🇺St. Petersburg, Russian Federation
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"
🇷🇺Yaroslavl, Russian Federation
Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"
🇷🇺Moscow, Russian Federation