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

NCT01265901 | Completed Phase 3 DMC

• 2 other identifiers: IMA901-3012010-022459-45
• Study Type: interventional
• Target: 339
• Locations: 11 countries
• Sites: 105

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma; First line; Eligible for sunitinib

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2015 (estimated)

Secondary Outcomes (5)

• Overall survival in biomarker-defined subgroup

  2015 (estimated)

• Progression-free survival

  2014 (estimated)

• Best tumor response

  2014 (estimated)

• Safety and tolerability

  continuously

• Cellular immunomonitoring

  2014 (estimated)

Study Arms (2)

Sunitinib

ACTIVE COMPARATOR

Sunitib as Standard therapy per Label.

Drug: Sunitinib

IMA901 plus GM-CSF added to sunitinib after single dose of cy

EXPERIMENTAL

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; Biological: GM-CSF; Drug: Cyclophosphamide; Drug: IMA901

Interventions

Sunitinib DRUG

As per label.

Also known as: Sutent

IMA901 plus GM-CSF added to sunitinib after single dose of cy; Sunitinib

GM-CSF BIOLOGICAL

Intradermal injection of GM-CSF as adjuvant.

Also known as: Granulocyte macrophage-colony stimulating factor, Leukine, Sargramostim

IMA901 plus GM-CSF added to sunitinib after single dose of cy

Cyclophosphamide DRUG

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

Also known as: Endoxan (EU name), Cytoxan (US name)

IMA901 plus GM-CSF added to sunitinib after single dose of cy

IMA901 DRUG

Intradermal vaccinations with IMA901 vaccine.

Also known as: IMA901 Vaccine

IMA901 plus GM-CSF added to sunitinib after single dose of cy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Immatics Biotechnologies GmbH: lead

Study Sites (105)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

Location

Kaiser Permanente Oncology Hematology Clinic

Denver, Colorado, 80205, United States

Location

Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

M.D. Anderson Cancer Center

Orlando, Florida, 32806, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

North Central Cancer Treatment Group, Illinois Cancer Care

Peoria, Illinois, 61615-7822, United States

Location

IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Weinberg Cancer Institute at Franklin Hospital

Baltimore, Maryland, 21237, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Clinical Research Alliance

Lake Success, New York, 11042, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

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

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

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

San Antonio, Texas, 78258, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Hôpital Saint André

Bordeaux, 33075, France

Location

Centre Francois Baclesse, Comite Urologie-Gynecologie

Caen, 14076, France

Location

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

Clermont-Ferrand, 63003, France

Location

Hospital Européen Georges Pompidou, Service d'oncologie medicale

Paris, 75015, France

Location

Centre Rene Gauducheau, Service d'oncologie medicale

Saint-Herblain, 44800, France

Location

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

Berlin, 12200, Germany

Location

Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH

Bochum, 44791, Germany

Location

Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)

Essen, 45122, Germany

Location

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

Hanover, 30625, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie

Heidelberg, 69120, Germany

Location

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

Leipzig, 04103, Germany

Location

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

Munich, 81675, Germany

Location

Urologische Klinik Dr. Castringius, München-Planegg

Planegg, 82152, Germany

Location

Klinikum St. Elisabeth Straubing GmbH

Straubing, 94315, Germany

Location

Klinik für Urologie, Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

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

Ulm, 89081, Germany

Location

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

Villingen-Schwenningen, 78052, Germany

Location

Péterfy Utcai Hospital, Urology department

Budapest, 1076, Hungary

Location

Semmelweis University, Urology Clinic

Budapest, 1082, Hungary

Location

Urology Department, Bajcsy-Zsilinszky Hospital

Budapest, 1106, Hungary

Location

Uzsoki Utcai Hospital, Oncoradiology Center

Budapest, 1145, Hungary

Location

University of Debrecen, Faculty of Medicine, Institute of Oncology

Debrecen, 4032, Hungary

Location

University of Debrecen, Faculty of Medicine, Urology Clinic

Debrecen, 4032, Hungary

Location

Kenézy Hospital, Urology Department

Debrecen, 4043, Hungary

Location

Oncology Centre, Markhot Ferenc Training Hospital and Clinic

Eger, 3300, Hungary

Location

Pándy Kálmán County Hospital, Oncology and Radiotherapy Center

Gyula, 5700, Hungary

Location

Urology department, BAZ County Hospital

Miskolc, 3526, Hungary

Location

Urology Clinic, University of Pécs

Pécs, 7621, Hungary

Location

Oncology Therapy Clinic, University of Szeged

Szeged, 6720, Hungary

Location

County Oncology Centre, Hetényi Géza Hospital

Szolnok, 5000, Hungary

Location

Oncology Department, Zala County Hospital

Zalaegerszeg, 8900, Hungary

Location

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

Arezzo, 52100, Italy

Location

Centro di riferimento Oncologico di Aviano

Aviano, 33081, Italy

Location

Medical Oncology Unit, Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

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

Modena, 41100, Italy

Location

Dipartimento di Oncologia, IRCCS Fondazione

Pavia, 27100, Italy

Location

Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia

Reggio Emilia, 42100, Italy

Location

Oncologia Medica, "Ospedale Infermi"

Rimini, 47923, Italy

Location

Ospedale S.S Annunziata Sasari

Sassari, 07100, Italy

Location

IRCC-Istituto di Ricerca e Cura del Cancro

Torino, 10060, Italy

Location

University Medical Center St. Radboud Centraal, Department of Urology

Nijmegen, 6525, Netherlands

Location

University Hospital, UOS - Radiumhospital

Oslo, 0310, Norway

Location

Białostockie Centrum Onkologii

Bialystok, 15-027, Poland

Location

Prof. Franciszek Łukaszczyk Oncology Center

Bydgoszcz, 85-796, Poland

Location

Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna

Dobra, 72-003, Poland

Location

Wojewódzki Szpital Zespolony, Oncology Department

Elblag, 82-300, Poland

Location

Uniwersyteckie Centrum Kliniczne, Klinika Urologii

Gdansk, 80-214, Poland

Location

Chemotherapy Department Center of Oncology of the Lublin Region

Lublin, 20-090, Poland

Location

Olsztyński Oncology Center "KOPERNIK"

Olsztyn, 10-513, Poland

Location

Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic

Poznan, 60-569, Poland

Location

Private Outpatient Clinic MRUKMED

Rzeszów, 35-242, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

Szczecin, 70-111, Poland

Location

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

Warsaw, 02-005, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

Warsaw, 04-125, Poland

Location

Urology and Urological Oncology Department and Clinic

Warsaw, 50-566, Poland

Location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

"Prof. Dr. Ioan Chiricuta" Oncology Institute

Cluj-Napoca, 400015, Romania

Location

Medisprof SRL

Cluj-Napoca, 400058, Romania

Location

SC Oncolab SRL

Craiova, 200385, Romania

Location

Emergency Clinical County Hospital Oradea

Oradea, 410469, Romania

Location

Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department

Târgu Mureş, 540142, Romania

Location

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

Chelyabinsk, 454087, Russia

Location

Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan

Kazan', 420029, Russia

Location

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

Moscow, 115478, Russia

Location

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

Moscow, 117997, Russia

Location

Moscow Hertsen Scientific Research Oncological Institute

Moscow, 125284, Russia

Location

State Institution "City Clinical Hospital NO20"

Moscow, 129327, Russia

Location

Orenburg Regional Clinical Oncological Dispensary

Orenburg, 460021, Russia

Location

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

Rostov-on-Don, 344022, Russia

Location

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

Ryazan, 390011, Russia

Location

State Institution of Healthcare "Leningrad Regional Oncological Dispensary"

Saint Petersburg, 191104, Russia

Location

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

Saint Petersburg, 194354, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

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

Saratov, 410004, Russia

Location

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

Yaroslavl, 150040, Russia

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

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

Cambridge, CB2 0QQ, United Kingdom

Location

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

Leeds, LS9 7TF, United Kingdom

Location

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

Manchester, M20 4BX, United Kingdom

Location

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

Location

ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital

Preston, PR2 9HT, United Kingdom

Location

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

Southampton, SO16 6YD, United Kingdom

Location

Postgraduate Medical School, University of Surrey

Surrey, GU2 7WG, United Kingdom

Location

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

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27720136 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib; Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors; sargramostim; Cyclophosphamide; IMA901 vaccine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Brian Rini, MD

  Cleveland Clinic Taussig Cancer Institute

  PRINCIPAL INVESTIGATOR

• Tim Eisen, MD

  Addenbrooke's Hospital University of Cambridge, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 12, 2017

Record last verified: 2017-09

Locations

HU (14); GB (9); RU (17); RO (6); NO (1); US (17); IT (9); PL (13); FR (5); NL (1); DE (13)