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

Sponsor
Immatics Biotechnologies GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT01265901
Collaborator
(none)
339
Enrollment
106
Locations
2
Arms
55
Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
339 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sunitinib

Sunitib as Standard therapy per Label.

Drug: Sunitinib
As per label.
Other Names:
  • Sutent

    		•
    Experimental: 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

    Drug: Sunitinib
    As per label.
    Other Names:
  • Sutent

    • Biological: GM-CSF
    Intradermal injection of GM-CSF as adjuvant.
    Other Names:
  • 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)

    • Drug: IMA901
    Intradermal vaccinations with IMA901 vaccine.
    Other Names:
  • IMA901 Vaccine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [2015 (estimated)]

    Secondary Outcome Measures

    1. Overall survival in biomarker-defined subgroup [2015 (estimated)]

    2. Progression-free survival [2014 (estimated)]

    3. Best tumor response [2014 (estimated)]

    4. Safety and tolerability [continuously]

    5. Cellular immunomonitoring [2014 (estimated)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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):

    7. Hemoglobin < LLN,

    8. Serum corrected calcium > ULN,

    9. Karnofsky performance status < 80%,

    10. Time from initial diagnosis to initiation of therapy < 1 year,

    11. Absolute neutrophil count > ULN,

    12. Platelets > ULN.

    13. Able to understand the nature of the study and give written informed consent.

    14. Willingness and ability to comply with the study protocol for the duration of the study.

    15. 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.

    16. 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.

    1. 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).

    1. Pregnancy or breastfeeding.

    2. 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

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute Los Angeles California United States 90048
    3 Kaiser Permanente Oncology Hematology Clinic Denver Colorado United States 80205
    4 Georgetown University Medical Center, Lombardi Comprehensive Cancer Center Washington, D.C. District of Columbia United States 20007
    5 M.D. Anderson Cancer Center Orlando Florida United States 32806
    6 The University of Chicago Medicine Chicago Illinois United States 60637
    7 North Central Cancer Treatment Group, Illinois Cancer Care Peoria Illinois United States 61615-7822
    8 IU Simon Cancer Center Indianapolis Indiana United States 46202
    9 Weinberg Cancer Institute at Franklin Hospital Baltimore Maryland United States 21237
    10 Karmanos Cancer Institute Detroit Michigan United States 48201
    11 Clinical Research Alliance Lake Success New York United States 11042
    12 University of Cincinnati Cincinnati Ohio United States 45267
    13 Cleveland Clinic Taussig Cancer Institute Cleveland Ohio United States 44195
    14 UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology Pittsburgh Pennsylvania United States 15232
    15 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    16 South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care San Antonio Texas United States 78258
    17 Seattle Cancer Care Alliance Seattle Washington United States 98109
    18 Hôpital Saint André Bordeaux France 33075
    19 Centre Francois Baclesse, Comite Urologie-Gynecologie Caen Cedex France 14076
    20 CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire Clermont Ferrand Cedex France 63003
    21 Hospital Européen Georges Pompidou, Service d'oncologie medicale Paris France 75015
    22 Centre Rene Gauducheau, Service d'oncologie medicale Saint-Herblain France 44800
    23 Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz Berlin Germany 12200
    24 Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH Bochum Germany 44791
    25 Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn Bonn Germany 53127
    26 Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung) Essen Germany 45122
    27 Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover Hannover Germany 30625
    28 Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie Heidelberg Germany 69120
    29 Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig Leipzig Germany 04103
    30 Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München Munich Germany 81675
    31 Urologische Klinik Dr. Castringius, München-Planegg Planegg Germany 82152
    32 Klinikum St. Elisabeth Straubing GmbH Straubing Germany 94315
    33 Klinik für Urologie, Universitätsklinikum Tübingen Tübingen Germany 72076
    34 Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm Ulm Germany 89081
    35 Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie Villingen-Schwenningen Germany 78052
    36 Péterfy Utcai Hospital, Urology department Budapest Hungary 1076
    37 Semmelweis University, Urology Clinic Budapest Hungary 1082
    38 Urology Department, Bajcsy-Zsilinszky Hospital Budapest Hungary 1106
    39 Uzsoki Utcai Hospital, Oncoradiology Center Budapest Hungary 1145
    40 University of Debrecen, Faculty of Medicine, Institute of Oncology Debrecen Hungary 4032
    41 University of Debrecen, Faculty of Medicine, Urology Clinic Debrecen Hungary 4032
    42 Kenézy Hospital, Urology Department Debrecen Hungary 4043
    43 Oncology Centre, Markhot Ferenc Training Hospital and Clinic Eger Hungary 3300
    44 Pándy Kálmán County Hospital, Oncology and Radiotherapy Center Gyula Hungary 5700
    45 Urology department, BAZ County Hospital Miskolc Hungary 3526
    46 Urology Clinic, University of Pécs Pécs Hungary 7621
    47 Oncology Therapy Clinic, University of Szeged Szeged Hungary 6720
    48 County Oncology Centre, Hetényi Géza Hospital Szolnok Hungary 5000
    49 Oncology Department, Zala County Hospital Zalaegerszeg Hungary 8900
    50 Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica Arezzo Italy 52100
    51 Centro di riferimento Oncologico di Aviano Aviano Italy 33081
    52 Medical Oncology Unit, Policlinico Sant'Orsola Malpighi Bologna Italy 40138
    53 Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia Modena Italy 41100
    54 Dipartimento di Oncologia, IRCCS Fondazione Pavia Italy 27100
    55 Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia Reggio Emilia Italy 42100
    56 Oncologia Medica, "Ospedale Infermi" Rimini Italy 47923
    57 Ospedale S.S Annunziata Sasari Sassari Italy 07100
    58 IRCC-Istituto di Ricerca e Cura del Cancro Torino Italy 10060
    59 University Medical Center St. Radboud Centraal, Department of Urology Nijmegen Netherlands 6525
    60 University Hospital, UOS - Radiumhospital Oslo Norway 0310
    61 Białostockie Centrum Onkologii Białystok Poland 15-027
    62 Prof. Franciszek Łukaszczyk Oncology Center Bydgoszcz Poland 85-796
    63 Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna Dobra Poland 72-003
    64 Wojewódzki Szpital Zespolony, Oncology Department Elbląg Poland 82-300
    65 Uniwersyteckie Centrum Kliniczne, Klinika Urologii Gdańsk Poland 80-214
    66 Chemotherapy Department Center of Oncology of the Lublin Region Lublin Poland 20-090
    67 Olsztyński Oncology Center "KOPERNIK" Olsztyn Poland 10-513
    68 Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic Poznań Poland 60-569
    69 Private Outpatient Clinic MRUKMED Rzeszów Poland 35-242
    70 Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie Szczecin Poland 70-111
    71 Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic Warsaw Poland 02-005
    72 Niepubliczny Zaklad Opieki Zdrowotnej "Magodent" Warsaw Poland 04-125
    73 Urology and Urological Oncology Department and Clinic Warsaw Poland 50-566
    74 Fundeni Clinical Institute Bucharest Romania 022328
    75 "Prof. Dr. Ioan Chiricuta" Oncology Institute Cluj Napoca Romania 400015
    76 "Prof. Dr. Ioan Chiricuta" Oncology Institute Cluj-Napoca Romania 400015
    77 Medisprof SRL Cluj-Napoca Romania 400058
    78 SC Oncolab SRL Craiova Romania 200385
    79 Emergency Clinical County Hospital Oradea Oradea Romania 410469
    80 Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department Targu-Mures Romania 540142
    81 State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary" Chelyabinsk Russian Federation 454087
    82 Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan Kazan Russian Federation 420029
    83 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
    84 Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation" Moscow Russian Federation 117997
    85 Moscow Hertsen Scientific Research Oncological Institute Moscow Russian Federation 125284
    86 State Institution "City Clinical Hospital NO20" Moscow Russian Federation 129327
    87 Orenburg Regional Clinical Oncological Dispensary Orenburg Russian Federation 460021
    88 State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav" Rostov-on-Don Russian Federation 344022
    89 State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary" Ryazan Russian Federation 390011
    90 Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC" Saratov Russian Federation 410004
    91 State Institution of Healthcare "Leningrad Regional Oncological Dispensary" St. Petersburg Russian Federation 191104
    92 Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02" St. Petersburg Russian Federation 194354
    93 Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary" St. Petersburg Russian Federation 197022
    94 Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation" St. Petersburg Russian Federation 197758
    95 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
    96 Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology) St. Petersburg Russian Federation 197758
    97 State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital" Yaroslavl Russian Federation 150040
    98 Royal Bournemouth Hospital Bournemouth United Kingdom BH7 7DW
    99 Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center Cambridge United Kingdom CB2 0QQ
    100 Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital Leeds United Kingdom LS9 7TF
    101 Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology Manchester United Kingdom M20 4BX
    102 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
    103 ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital Preston United Kingdom PR2 9HT
    104 CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital Southampton United Kingdom SO16 6YD
    105 Postgraduate Medical School, University of Surrey Surrey United Kingdom GU2 7WG
    106 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Immatics Biotechnologies GmbH
    ClinicalTrials.gov Identifier:
    NCT01265901
    Other Study ID Numbers:
    • IMA901-301
    • 2010-022459-45
    First Posted:
    Dec 23, 2010
    Last Update Posted:
    Oct 12, 2017
    Last Verified:
    Sep 1, 2017
    Keywords provided by Immatics Biotechnologies GmbH
    Metastatic Renal Cell Carcinoma
    First line
    Eligible for sunitinib
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Cyclophosphamide
    Sunitinib
    Molgramostim
    Sargramostim

    Study Results

    No Results Posted as of Oct 12, 2017