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Metastatic Renal Cell CarcinomaPhase 3NCT01265901

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

A Phase 3 study testing Sunitinib, GM-CSF and Cyclophosphamide in people with Metastatic Renal Cell Carcinoma, run by Immatics Biotechnologies GmbH at 105 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
Sunitinib, GM-CSF and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
339 participants
Where
105 sitesin 11 countries
Study dates
Dec 2010to Jul 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

105 sites in 11 countries.

105 sites in 11 countries

United States17 sites

  • Weinberg Cancer Institute at Franklin Hospital

    Baltimore, Maryland, 21237

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Kaiser Permanente Oncology Hematology Clinic

    Denver, Colorado, 80205

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • IU Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • M.D. Anderson Cancer Center

    Orlando, Florida, 32806

  • North Central Cancer Treatment Group, Illinois Cancer Care

    Peoria, Illinois, 61615-7822

  • UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology

    Pittsburgh, Pennsylvania, 15232

  • South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care

    San Antonio, Texas, 78258

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Russia17 sites

  • State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"

    Chelyabinsk, 454087

  • Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan

    Kazan', 420029

  • Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"

    Moscow, 115478

  • Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"

    Moscow, 117997

  • Moscow Hertsen Scientific Research Oncological Institute

    Moscow, 125284

  • State Institution "City Clinical Hospital NO20"

    Moscow, 129327

  • Orenburg Regional Clinical Oncological Dispensary

    Orenburg, 460021

  • State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"

    Rostov-on-Don, 344022

  • State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"

    Ryazan, 390011

  • State Institution of Healthcare "Leningrad Regional Oncological Dispensary"

    Saint Petersburg, 191104

  • Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"

    Saint Petersburg, 194354

  • Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

  • Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"

    Saint Petersburg, 197758

  • Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"

    Saint Petersburg, 197758

  • Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)

    Saint Petersburg, 197758

  • Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"

    Saratov, 410004

  • State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"

    Yaroslavl, 150040

Other trials in Russia

Hungary14 sites

  • Péterfy Utcai Hospital, Urology department

    Budapest, 1076

  • Semmelweis University, Urology Clinic

    Budapest, 1082

  • Urology Department, Bajcsy-Zsilinszky Hospital

    Budapest, 1106

  • Uzsoki Utcai Hospital, Oncoradiology Center

    Budapest, 1145

  • University of Debrecen, Faculty of Medicine, Institute of Oncology

    Debrecen, 4032

  • University of Debrecen, Faculty of Medicine, Urology Clinic

    Debrecen, 4032

  • Kenézy Hospital, Urology Department

    Debrecen, 4043

  • Oncology Centre, Markhot Ferenc Training Hospital and Clinic

    Eger, 3300

  • Pándy Kálmán County Hospital, Oncology and Radiotherapy Center

    Gyula, 5700

  • Urology department, BAZ County Hospital

    Miskolc, 3526

  • Urology Clinic, University of Pécs

    Pécs, 7621

  • Oncology Therapy Clinic, University of Szeged

    Szeged, 6720

  • County Oncology Centre, Hetényi Géza Hospital

    Szolnok, 5000

  • Oncology Department, Zala County Hospital

    Zalaegerszeg, 8900

Other trials in Hungary

Germany13 sites

  • Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz

    Berlin, 12200

  • Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH

    Bochum, 44791

  • Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)

    Essen, 45122

  • Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover

    Hanover, 30625

  • Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie

    Heidelberg, 69120

  • Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig

    Leipzig, 04103

  • Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München

    Munich, 81675

  • Urologische Klinik Dr. Castringius, München-Planegg

    Planegg, 82152

  • Klinikum St. Elisabeth Straubing GmbH

    Straubing, 94315

  • Klinik für Urologie, Universitätsklinikum Tübingen

    Tübingen, 72076

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

    Ulm, 89081

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie

    Villingen-Schwenningen, 78052

Other trials in Germany

Poland13 sites

  • Białostockie Centrum Onkologii

    Bialystok, 15-027

  • Prof. Franciszek Łukaszczyk Oncology Center

    Bydgoszcz, 85-796

  • Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna

    Dobra, 72-003

  • Wojewódzki Szpital Zespolony, Oncology Department

    Elblag, 82-300

  • Uniwersyteckie Centrum Kliniczne, Klinika Urologii

    Gdansk, 80-214

  • Chemotherapy Department Center of Oncology of the Lublin Region

    Lublin, 20-090

  • Olsztyński Oncology Center "KOPERNIK"

    Olsztyn, 10-513

  • Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic

    Poznan, 60-569

  • Private Outpatient Clinic MRUKMED

    Rzeszów, 35-242

  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

    Szczecin, 70-111

  • Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic

    Warsaw, 02-005

  • Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

    Warsaw, 04-125

  • Urology and Urological Oncology Department and Clinic

    Warsaw, 50-566

Other trials in Poland

Italy9 sites

  • Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica

    Arezzo, 52100

  • Centro di riferimento Oncologico di Aviano

    Aviano, 33081

  • Medical Oncology Unit, Policlinico Sant'Orsola Malpighi

    Bologna, 40138

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

    Modena, 41100

  • Dipartimento di Oncologia, IRCCS Fondazione

    Pavia, 27100

  • Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia

    Reggio Emilia, 42100

  • Oncologia Medica, "Ospedale Infermi"

    Rimini, 47923

  • Ospedale S.S Annunziata Sasari

    Sassari, 07100

  • IRCC-Istituto di Ricerca e Cura del Cancro

    Torino, 10060

Other trials in Italy

United Kingdom9 sites

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center

    Cambridge, CB2 0QQ

  • Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital

    Leeds, LS9 7TF

  • Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology

    Manchester, M20 4BX

  • Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology

    Oxford, OX3 7LJ

  • ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital

    Preston, PR2 9HT

  • CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital

    Southampton, SO16 6YD

  • Postgraduate Medical School, University of Surrey

    Surrey, GU2 7WG

  • South West Wales Cancer Institute, Singleton Hospital, School of Medicine

    Swansea, SA2 8QA

Other trials in United Kingdom

Romania6 sites

  • Fundeni Clinical Institute

    Bucharest, 022328

  • "Prof. Dr. Ioan Chiricuta" Oncology Institute

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400058

  • SC Oncolab SRL

    Craiova, 200385

  • Emergency Clinical County Hospital Oradea

    Oradea, 410469

  • Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department

    Târgu Mureş, 540142

Other trials in Romania

France5 sites

  • Hôpital Saint André

    Bordeaux, 33075

  • Centre Francois Baclesse, Comite Urologie-Gynecologie

    Caen, 14076

  • CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire

    Clermont-Ferrand, 63003

  • Hospital Européen Georges Pompidou, Service d'oncologie medicale

    Paris, 75015

  • Centre Rene Gauducheau, Service d'oncologie medicale

    Saint-Herblain, 44800

Other trials in France

Netherlands1 site

  • University Medical Center St. Radboud Centraal, Department of Urology

    Nijmegen, 6525

Other trials in Netherlands

Norway1 site

  • University Hospital, UOS - Radiumhospital

    Oslo, 0310

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Sunitinib, GM-CSF, Cyclophosphamide, IMA901
Keywords
Metastatic Renal Cell Carcinoma, First line, Eligible for sunitinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunitinibDrug

    Also called Sutent

    As per label.

  • GM-CSFBiological

    Also called Granulocyte macrophage-colony stimulating factor, Leukine, Sargramostim

    Intradermal injection of GM-CSF as adjuvant.

  • CyclophosphamideDrug

    Also called Endoxan (EU name), Cytoxan (US name)

    One single low-dose i.v. infusion prior to the first vaccination

  • IMA901Drug

    Also called IMA901 Vaccine

    Intradermal vaccinations with IMA901 vaccine.

Study groups in NCT01265901
Study groupRoleWhat they receive
SunitinibActive comparatorSunitib as Standard therapy per Label.
Receives: Drug: Sunitinib
IMA901 plus GM-CSF added to sunitinib after single dose of cyExperimentalAfter 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
Receives: Drug: Sunitinib; Biological: GM-CSF; Drug: Cyclophosphamide; Drug: IMA901

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 2015 (estimated)

Secondary outcomes (5)

  1. Overall survival in biomarker-defined subgroup

    Measured: 2015 (estimated)

  2. Progression-free survival

    Measured: 2014 (estimated)

  3. Best tumor response

    Measured: 2014 (estimated)

  4. Safety and tolerability

    Measured: continuously

  5. Cellular immunomonitoring

    Measured: 2014 (estimated)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
339 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01265901
Sponsor's protocol ID
IMA901-301
Other IDs
2010-022459-45
Status last verified
Sep 2017
First submitted
22 Dec 2010
Last updated
12 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27720136

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sunitinib, GM-CSF and Cyclophosphamide in people with Metastatic Renal Cell Carcinoma, run by Immatics Biotechnologies GmbH at 105 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Russia, Hungary, Germany, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 2015 (estimated)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01265901, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.

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