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

Information source: immatics Biotechnologies GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma

Intervention: Sunitinib (Drug); IMA901 plus GM-CSF (Biological); Cyclophosphamide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: immatics Biotechnologies GmbH

Official(s) and/or principal investigator(s):
Brian Rini, MD, Principal Investigator, Affiliation: Cleveland Clinic Taussig Cancer Institute
Tim Eisen, MD, Principal Investigator, Affiliation: Addenbrooke's Hospital University of Cambridge, UK

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall survival

Secondary outcome:

Overall survival in biomarker-defined subgroup

Progression-free survival

Best tumor response

Safety and tolerability

Cellular immunomonitoring

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hôpital Saint André, Bordeaux 33075, France

Centre Francois Baclesse, Comite Urologie-Gynecologie, Caen Cedex 14076, France

CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire, Clermont Ferrand Cedex 63003, France

Centre Rene Gauducheau, Service d'oncologie medicale, Nantes Saint Herblain Cedex 44800, France

Hospital Européen Georges Pompidou, Service d'oncologie medicale, Paris 75015, France

Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz, Berlin 12200, Germany

Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH, Bochum 44791, Germany

Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn, Bonn 53127, Germany

Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung), Essen 45122, Germany

Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover 30625, Germany

Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie, Heidelberg 69120, Germany

Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig, Leipzig 04103, Germany

Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München, Munich 81675, Germany

Urologische Klinik Dr. Castringius, München-Planegg, Planegg 82152, Germany

Klinikum St. Elisabeth Straubing GmbH, Straubing 94315, Germany

Klinik für Urologie, Universitätsklinikum Tübingen, Tübingen 72076, Germany

Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm, Ulm 89081, Germany

Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie, Villingen-Schwenningen 78052, Germany

Péterfy Utcai Hospital, Urology department, Budapest 1076, Hungary

Semmelweis University, Urology Clinic, Budapest 1082, Hungary

Urology Department, Bajcsy-Zsilinszky Hospital, Budapest 1106, Hungary

Uzsoki Utcai Hospital, Oncoradiology Center, Budapest 1145, Hungary

Kenézy Hospital, Urology Department, Debrecen 4043, Hungary

University of Debrecen, Faculty of Medicine, Institute of Oncology, Debrecen 4032, Hungary

University of Debrecen, Faculty of Medicine, Urology Clinic, Debrecen 4032, Hungary

Oncology Centre, Markhot Ferenc Training Hospital and Clinic, Eger 3300, Hungary

Pándy Kálmán County Hospital, Oncology and Radiotherapy Center, Gyula 5700, Hungary

Urology department, BAZ County Hospital, Miskolc 3526, Hungary

Urology Clinic, University of Pécs, Pécs 7621, Hungary

Oncology Therapy Clinic, University of Szeged, Szeged 6720, Hungary

County Oncology Centre, Hetényi Géza Hospital, Szolnok 5000, Hungary

Oncology Department, Zala County Hospital, Zalaegerszeg-Pózva 8900, Hungary

Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica, Arezzo 52100, Italy

Centro di riferimento Oncologico di Aviano, Aviano 33081, Italy

Medical Oncology Unit, Policlinico Sant'Orsola Malpighi, Bologna 40138, Italy

Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia, Modena 41100, Italy

Dipartimento di Oncologia, IRCCS Fondazione, Pavia 27100, Italy

Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia, Reggio Emilia 42100, Italy

Oncologia Medica, "Ospedale Infermi", Rimini 47923, Italy

Ospedale S.S Annunziata Sasari, Sassari 07100, Italy

IRCC-Istituto di Ricerca e Cura del Cancro, Torino 10060, Italy

University Medical Center St. Radboud Centraal, Department of Urology, Nijmwegen 6525, Netherlands

University Hospital, UOS - Radiumhospital, Oslo 0310, Norway

Białostockie Centrum Onkologii, Białystok 15-027, Poland

Prof. Franciszek Łukaszczyk Oncology Center, Bydgoszcz 85-796, Poland

Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna, Dobra 72-003, Poland

Wojewódzki Szpital Zespolony, Oncology Department, Elbląg 82-300, Poland

Uniwersyteckie Centrum Kliniczne, Klinika Urologii, Gdańsk 80-214, Poland

Chemotherapy Department Center of Oncology of the Lublin Region, Lublin 20-090, Poland

Olsztyński Oncology Center "KOPERNIK", Olsztyn 10-513, Poland

Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic, Poznań 60-569, Poland

Private Outpatient Clinic MRUKMED, Rzeszów 35-242, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Szczecin 70-111, Poland

Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic, Warsaw 02-005, Poland

Niepubliczny Zaklad Opieki Zdrowotnej "Magodent", Warsaw 04-125, Poland

Urology and Urological Oncology Department and Clinic, Warsaw 50-566, Poland

Fundeni Clinical Institute, Bucharest 022328, Romania

"Prof. Dr. Ioan Chiricuta" Oncology Institute, Cluj Napoca 400015, Romania

"Prof. Dr. Ioan Chiricuta" Oncology Institute, Cluj-Napoca 400015, Romania

Medisprof SRL, Cluj-Napoca 400058, Romania

SC Oncolab SRL, Craiova 200385, Romania

Emergency Clinical County Hospital Oradea, Oradea 410469, Romania

Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department, Targu-Mures 540142, Romania

State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary", Chelyabinsk 454087, Russian Federation

Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan, Kazan 420029, Russian Federation

Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation", Moscow 117997, 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 115478, Russian Federation

Moscow Hertsen Scientific Research Oncological Institute, Moscow 125284, Russian Federation

State Institution "City Clinical Hospital NO20", Moscow 129327, Russian Federation

Orenburg Regional Clinical Oncological Dispensary, Orenburg 460021, Russian Federation

State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav", Rostov-on-Don 344022, Russian Federation

State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary", Ryazan 390011, Russian Federation

Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC", Saratov 410004, Russian Federation

Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation", St. Petersburg 197758, Russian Federation

Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation", St. Petersburg 197758, Russian Federation

Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary", St. Petersburg 197022, Russian Federation

Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology), St. Petersburg 197758, Russian Federation

Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02", St. Petersburg 194354, Russian Federation

State Institution of Healthcare "Leningrad Regional Oncological Dispensary", St. Petersburg 191104, Russian Federation

State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital", Yaroslavl 150040, Russian Federation

Royal Bournemouth Hospital, Bournemouth BH7 7DW, United Kingdom

Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center, Cambridge CB2 0QQ, United Kingdom

Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital, Leeds LS9 7TF, United Kingdom

Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology, Manchester M20 4BX, United Kingdom

Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology, Oxford OX3 7LJ, United Kingdom

ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital, Preston PR2 9HT, United Kingdom

CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital, Southampton SO16 6YD, United Kingdom

Postgraduate Medical School, University of Surrey, Surrey GU2 7WG, United Kingdom

South West Wales Cancer Institute, Singleton Hospital, School of Medicine, Swansea SA2 8QA, United Kingdom

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California 90048, United States

Kaiser Permanente Oncology Hematology Clinic, Denver, Colorado 80205, United States

Georgetown University Medical Center, Lombardi Comprehensive Cancer Center, Washington, District of Columbia 20007, United States

M.D. Anderson Cancer Center, Orlando, Florida 32806, United States

The University of Chicago Medicine, Chicago, Illinois 60637, United States

North Central Cancer Treatment Group, Illinois Cancer Care, Peoria, Illinois 61615-7822, United States

IU Simon Cancer Center, Indianapolis, Indiana 46202, United States

Weinberg Cancer Institute at Franklin Hospital, Baltimore, Maryland 21237, United States

Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Clinical Research Alliance, Lake Success, New York 11042, United States

University of Cincinnati, Cincinnati, Ohio 45267, United States

Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio 44195, United States

UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology, Pittsburgh, Pennsylvania 15232, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, United States

South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care, San Antonio, Texas 78258, United States

Seattle Cancer Care Alliance, Seattle, Washington 98109, United States

Additional Information

Starting date: December 2010
Last updated: August 17, 2015

Page last updated: August 23, 2015

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