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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
immatics Biotechnologies GmbH
ClinicalTrials.gov Identifier:
NCT01265901
First received: December 22, 2010
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Sunitinib
Biological: IMA901 plus GM-CSF
Drug: Cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by immatics Biotechnologies GmbH:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2015 (estimated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival in biomarker-defined subgroup [ Time Frame: 2015 (estimated) ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]
  • Best tumor response [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
  • Cellular immunomonitoring [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: December 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sunitinib Drug: Sunitinib
as per label
Other Name: Sutent
Experimental: IMA901 plus GM-CSF added to sunitinib Biological: IMA901 plus GM-CSF
After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant will be applied for a period of 4 months while continuing treatment with sunitinib
Other Names:
  • Sutent
  • TUMAP
  • Granulocyte macrophage-colony stimulating factor
  • Leukine
  • Sargramostim
Drug: Cyclophosphamide
One single low-dose i.v. infusion prior to the first vaccination
Other Names:
  • Endoxan (EU name)
  • Cytoxan (US name)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265901

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
United States, Colorado
Kaiser Permanente Oncology Hematology Clinic
Denver, Colorado, United States, 80205
United States, District of Columbia
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
M.D. Anderson Cancer Center
Orlando, Florida, United States, 32806
United States, Illinois
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
North Central Cancer Treatment Group, Illinois Cancer Care
Peoria, Illinois, United States, 61615-7822
United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Weinberg Cancer Institute at Franklin Hospital
Baltimore, Maryland, United States, 21237
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care
San Antonio, Texas, United States, 78258
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
France
Hôpital Saint André
Bordeaux, France, 33075
Centre Francois Baclesse, Comite Urologie-Gynecologie
Caen Cedex, France, 14076
CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire
Clermont Ferrand Cedex, France, 63003
Centre Rene Gauducheau, Service d'oncologie medicale
Nantes Saint Herblain Cedex, France, 44800
Hospital Européen Georges Pompidou, Service d'oncologie medicale
Paris, France, 75015
Germany
Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz
Berlin, Germany, 12200
Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH
Bochum, Germany, 44791
Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn
Bonn, Germany, 53127
Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)
Essen, Germany, 45147
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover
Hannover, Germany, 30625
Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie
Heidelberg, Germany, 69120
Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München
Munich, Germany, 81675
Urologische Klinik Dr. Castringius, München-Planegg
Planegg, Germany, 82152
Klinikum St. Elisabeth Straubing GmbH
Straubing, Germany, 94315
Klinik für Urologie, Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm
Ulm, Germany, 89081
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie
Villingen-Schwenningen, Germany, 78052
Hungary
Semmelweis University, Urology Clinic
Budapest, Hungary, 1082
Péterfy Utcai Hospital, Urology department
Budapest, Hungary, 1076
Uzsoki Utcai Hospital, Oncoradiology Center
Budapest, Hungary, 1145
Urology Department, Bajcsy-Zsilinszky Hospital
Budapest, Hungary, 1106
Kenézy Hospital, Urology Department
Debrecen, Hungary, 4043
University of Debrecen, Faculty of Medicine, Urology Clinic
Debrecen, Hungary, 4032
University of Debrecen, Faculty of Medicine, Institute of Oncology
Debrecen, Hungary, 4032
Oncology Centre, Markhot Ferenc Hospital
Eger, Hungary, 3300
Pándy Kálmán County Hospital, Oncology and Radiotherapy Center
Gyula, Hungary, 5700
Urology department, BAZ County Hospital
Miskolc, Hungary, 3526
Urology Clinic, University of Pécs
Pécs, Hungary, 7621
Oncology Therapy Clinic, University of Szeged
Szeged, Hungary, 6720
County Oncology Centre, Hetényi Géza Hospital
Szolnok, Hungary, 5000
Oncology Department, Zala County Hospital
Zalaegerszeg-Pózva, Hungary, 8900
Italy
Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica
Arezzo, Italy, 52100
Centro di riferimento Oncologico di Aviano
Aviano, Italy, 33081
Medical Oncology Unit, Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia
Modena, Italy, 41100
Dipartimento di Oncologia, IRCCS Fondazione
Pavia, Italy, 27100
Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia
Reggio Emilia, Italy, 42100
Oncologia Medica, "Ospedale Infermi"
Rimini, Italy, 47923
Ospedale S.S Annunziata Sasari
Sassari, Italy, 07100
IRCC-Istituto di Ricerca e Cura del Cancro
Torino, Italy, 10060
Netherlands
University Medical Center St. Radboud Centraal, Department of Urology
Nijmwegen, Netherlands, 6525
Norway
University Hospital, UOS - Radiumhospital
Oslo, Norway, 0310
Poland
Białostockie Centrum Onkologii
Białystok, Poland, 15-027
Prof. Franciszek Łukaszczyk Oncology Center
Bydgoszcz, Poland, 85-796
Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna
Dobra, Poland, 72-003
Wojewódzki Szpital Zespolony, Oncology Department
Elbląg, Poland, 82-300
Uniwersyteckie Centrum Kliniczne, Klinika Urologii
Gdańsk, Poland, 80-214
Chemotherapy Department Center of Oncology of the Lublin Region
Lublin, Poland, 20-090
Olsztyński Oncology Center "KOPERNIK"
Olsztyn, Poland, 10-513
Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic
Poznań, Poland, 60-569
Private Outpatient Clinic MRUKMED
Rzeszów, Poland, 35-242
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, Poland, 70-111
Urology and Urological Oncology Department and Clinic
Warsaw, Poland, 50-566
Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic
Warsaw, Poland, 02-005
Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
Warsaw, Poland, 04-125
Romania
Fundeni Clinical Institute
Bucharest, Romania, 022328
"Prof. Dr. Ioan Chiricuta" Oncology Institute
Cluj Napoca, Romania, 400015
Medisprof SRL
Cluj-Napoca, Romania, 400058
"Prof. Dr. Ioan Chiricuta" Oncology Institute
Cluj-Napoca, Romania, 400015
SC Oncolab SRL
Craiova, Romania, 200385
Emergency Clinical County Hospital Oradea
Oradea, Romania, 410469
Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department
Targu-Mures, Romania, 540142
Russian Federation
State Treatment and Preventive Care Institution "Chelyabinsk regional clinical oncological Dispensary"
Chelyabinsk, Russian Federation, 454087
Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
Kazan, Russian Federation, 420029
Moscow Hertsen Scientific Research Oncological Institute
Moscow, Russian Federation, 125284
State Institution "City Clinical Hospital NO20"
Moscow, Russian Federation, 129327
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, 115478
Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare and Social Development of Russian Federation"
Moscow, Russian Federation, 117997
Orenburg Regional Clinical Oncological Dispensary
Orenburg, Russian Federation, 460021
State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"
Rostov-on-Don, Russian Federation, 344022
State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"
Ryazan, Russian Federation, 390011
Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"
Saratov, Russian Federation, 410004
Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"
St. Petersburg, Russian Federation, 197758
Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"
St. Petersburg, Russian Federation, 197022
State Institution of Healthcare "Leningrad Regional Oncological Dispensary"
St. Petersburg, Russian Federation, 191104
Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"
St. Petersburg, Russian Federation, 194354
Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"
St. Petersburg, Russian Federation, 197758
Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)
St. Petersburg, Russian Federation, 197758
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"
Yaroslavl, Russian Federation, 150040
United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center
Cambridge, United Kingdom, CB2 0QQ
Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital
Leeds, United Kingdom, LS9 7TF
Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology
Manchester, United Kingdom, M20 4BX
Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology
Oxford, United Kingdom, OX3 7LJ
ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital
Preston, United Kingdom, PR2 9HT
CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Postgraduate Medical School, University of Surrey
Surrey, United Kingdom, GU2 7WG
South West Wales Cancer Institute, Singleton Hospital, School of Medicine
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
immatics Biotechnologies GmbH
Investigators
Principal Investigator: Brian Rini, MD Cleveland Clinic Taussig Cancer Institute
Principal Investigator: Tim Eisen, MD Addenbrooke's Hospital University of Cambridge, UK
  More Information

No publications provided

Responsible Party: immatics Biotechnologies GmbH
ClinicalTrials.gov Identifier: NCT01265901     History of Changes
Other Study ID Numbers: IMA901-301, 2010-022459-45
Study First Received: December 22, 2010
Last Updated: January 13, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Germany: Paul-Ehrlich-Institut
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Hungary: Scientific and Medical Research Council Ethics Committee
Italy: The Italian Medicines Agency
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Independent Ethics Committee
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
Norway: Regional Ethics Commitee
Norway: Norwegian Medicines Agency

Keywords provided by immatics Biotechnologies GmbH:
Metastatic Renal Cell Carcinoma
First line
Eligible for sunitinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Cyclophosphamide
Sunitinib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014