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Renal Cell CarcinomaPhase 2IMA901-202NCT00523159

IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease

A Phase 2 study testing Endoxana, IMA901, Leukine and IMA901 and Leukine in people with Renal Cell Carcinoma, run by Immatics Biotechnologies GmbH at 44 sites in 10 countries.

Completed

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

Official record
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Trial summary

This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma. Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Endoxana, IMA901, Leukine and IMA901 and Leukine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
44 sitesin 10 countries
Study dates
May 2007to Aug 2009
Phase
Phase 2
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
  • Histologically documented advanced clear-cell RCC
  • Patients who have received first-line tyrosine kinase inhibitor or cytokine systemic therapy for advanced disease systematic therapy for advanced disease and must be candidates for second-line therapy (NOTE: in Germany and Austria only patients after first-line tyrosine kinase inhibitor failure will be included into the study)
  • Patients having experienced documented tumor progression
  • At least one unidimensional measurable target lesion
Show all 10Show fewer
  • Karnofsky Performance Status ≥ 80%
  • Favorable or intermediate risk according to the 3-score MSKCC criteria.
  • 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

Who cannot join

  • Poor risk according to the 3-score MSKCC criteria
  • Immunosuppressive therapy within 4 weeks before study entry, e.g. corticosteroid treatment
  • History of other malignant tumors, except non-melanoma-skin cancer or curatively excised cervical carcinoma in situ
  • Presence of brain metastases on MRI or CT scan
  • Patients with a history or evidence of systemic autoimmune disease
  • Any vaccination in the two weeks before study entry
Show all 29Show fewer
  • Any planned prophylactic vaccination from study entry until the end of the induction period (5 weeks after the first vaccination)
  • Known active hepatitis B or C infection
  • Known HIV infection
  • Any other infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patient tissues.
  • Any of the following in the 4 weeks before study entry:
  • Major surgery
  • Anticancer treatments including (but not limited to) cytotoxic chemotherapy, radiotherapy, immunotherapy, hormone therapy, tyrosine kinase inhibitors, monoclonal antibodies
  • Unresolved toxicity from prior anticancer treatments including (but not limited to) cytotoxic chemotherapy, hormone therapy, tyrosine kinase inhibitors, monoclonal antibodies, radiotherapy, or immunotherapy
  • Received study drug within any clinical study
  • Any of the following abnormal laboratory values:
  • Hematology: Hb < 9 g/dL; WBC < 3 x 109/L; neutrophils < 1.5 x 109/L; lymphocytes < 1.0 x 109/L; platelets < 100 x 109/L
  • Liver function: serum bilirubin > 1.5 x upper normal limit (unless a history of Gilbert's disease); ALAT or ASAT > 3 x upper normal limit (>5 x upper normal limit if liver metastases are present)
  • Renal function: serum creatinine > 200 µmol/L
  • Patients with other significant diseases currently uncontrolled by treatment which might interfere with study completion, for example:
  • Heart failure or non compensated active heart disease
  • Severe coronary heart disease, cardiac arrhythmia requiring medication, or uncontrolled hypertension
  • Symptomatic neurotoxicity (motor or sensory) ≥ grade 2 National Cancer Institute - Common Toxicity Criteria (NCI-CTC).
  • Severe pulmonary dysfunction
  • Psychiatric disabilities, seizures or central nervous system disorders that may interfere with the ability to give informed consent or perform adequate follow-up in the investigator's opinion
  • Active infections requiring oral or intravenous antibiotics
  • Women or men who decline to practice a medically approved method of contraception
  • 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

44 sites in 10 countries.

44 sites in 10 countries

Germany13 sites

  • Charité Campus Mitte-Klinik für Urologie

    Berlin, 10117

  • Charité Campus Benjamin Franklin - Medizinische Klinik III

    Berlin, 12203

  • Zeisigwaldkliniken Bethanien Chemnitz GmbH

    Chemnitz, 09130

  • Universitätsklinikum Essen

    Essen, 45122

  • Klinik der Johann-Wolfgang-Goethe-Universität

    Frankfurt am Main, 60590

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum (Onkologie / Hämatologie)

    Hamburg, 20246

  • Universitätsklinikum Heidelberg - Klinik für Urologie

    Heidelberg, 69120

  • Universitätsklinikum Schleswig Holstein - Campus Lübeck

    Lübeck, 23538

  • Universitätsklinikum Mainz - 3. Medizinische Klinik

    Mainz, 55131

  • Klinikum der Universität - München Großhadern

    Munich, 81377

  • Urologische Klinik Dr. Castringius - München-Planegg

    Planegg, 82152

  • Universitätsklinikum Tübingen - Klinik für Urologie

    Tübingen, 72076

  • Schwarzwald-Baar-Klinik - Abt. Hämatologie und Onkologie

    Villingen-Schwenningen, 78050

Other trials in Germany

Hungary9 sites

  • DRC Gyógyszervizsgáló Központ Kft

    Balatonfüred, 8230

  • Semmelweis Egyetem - Urológiai Klinika

    Budapest, 1082

  • Bajcsy-Zsilinszky Kórház - Urológia Osztály

    Budapest, 1106

  • Fövárosi Önk.Szt.Imre Kórház - Belgyógyászat-Kliniko-FFarmakológia

    Budapest, 1115

  • Országos Onkológiai Intézet - Kemoterápia C osztály-Klinikofarmakológia

    Budapest, 1122

  • Debreceni Egyetem Orvos és Egészségtudományi Centrum

    Debrecen, 4012

  • Hajdú-Bihar Megyei Önk. Kenézy Gyula Kórház/Urológia Osztály

    Debrecen, 4043

  • BAZ megyei Kórház - Urológia Osztály

    Miskolc, 3501

  • Pécs Orvostudomanyi Egyetem - Urológiai Klinika

    Pécs, 7621

Other trials in Hungary

Romania4 sites

  • Oncology Institute "Prof. Dr. Alexandru Trestioreanu"

    Bucharest, 022328

  • Oncology Institute - "Prof. Dr. Alexandru Trestioreanu"

    Bucharest, 022328

  • Oncology Institute "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, 400015

  • Clinical County Hospital Oradea

    Oradea, 4170167

Other trials in Romania

Slovakia4 sites

  • National Cancer Institut - "Narodny onkologicky ustav"

    Bratislava, 83310

  • Clinic of Radiotherapy and Oncology - East Slovak Oncology Institute

    Košice, 04191

  • Martin Faculty Hospital

    Martin, 03659

  • Department of Clinical Oncology - Faculty Hospital with Policlinic of J.A. Reiman

    Prešov, 08181

Other trials in Slovakia

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Puerta de Hierro

    Madrid, 28035

  • Hospital 12 de Octubre

    Madrid, 28041

  • Clinica Universitaria de Navarra - Servicio de Oncologia

    Pamplona, 31008

Other trials in Spain

Poland3 sites

  • Klinika Chemioterapii Nowotworow - Uniwersytetu Medycznego

    Lodz, 93509

  • Klinika Onkologii Wojskowego Institutu Medycznego

    Warsaw, 00909

  • Clinic of Urology and Urological Oncology Medica University Hospital

    Wroclaw, 50-043

Other trials in Poland

United Kingdom3 sites

  • Beatson Oncology Centre

    Glasgow, G11 6NT

  • Christie Hospital NHS Trust, CRUK Department of Medical Onkology - Paterson Institute for Cancer Research

    Manchester, M20 4BX

  • University of Surrey - Postgraduate Medical School

    Surrey, GU2 7WG

Other trials in United Kingdom

Bulgaria2 sites

  • National Oncology Hospital - Urology

    Sofia, 1233

  • Regional Oncodispensary with inpatient sector-Sofia District

    Sofia, 1233

Other trials in Bulgaria

Austria1 site

  • Medizinische Universität Salzburg - Universitätsklinik für Innere Medizin III

    Salzburg, 5020

Other trials in Austria

Switzerland1 site

  • University Hospital - Medicine Oncology

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Phase 2, Randomized, Open Label, Multicenter Study of Intradermal IMA901 Plus GM-CSF With or Without Low Dose Cyclophosphamide Pre-treatment in Advanced Renal Cell Carcinoma Patients With Measurable Disease

This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma.

Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination.

Read the detailed description

This is a multicenter, open label, randomized phase 2 study which investigated the effect of a second-line systemic treatment with IMA901 plus GM-CSF in RCC patients. Randomization was done according to a pre-treatment with low-dose cyclophosphamide (CY). Secondary endpoints comprised tumor response parameters.

The study population consisted of HLA-A*02-positive men or women with advanced RCC of the clear-cell type classified as having a favorable or intermediate risk after first-line systemic therapy for. Patients had to be aged 18 years or older, had at least have one measurable tumor lesion and had have received first-line tyrosine kinase inhibitor or cytokine systemic therapy for advanced disease, during or after which the patient had experienced disease progression.

Patients in both arms received a total of 17 vaccinations with GM-CSF followed by IMA901 during the 9 month treatment period.

At screening baseline tumor status was assessed by CT or MRI. During the study tumor assessments were performed every 6 weeks.

Immunomonitoring (T-cell responses to peptides contained in IMA901 and analysis of other immune cell populations that may influence T-cell responses), serum levels of antibodies and molecules with suspected influence on immune response were assessed on several occasions during the study.

Safety assessment comprised continuous adverse event reporting, regular physical examinations and regular assessments of vital signs, hematology, blood chemistry and urine. A 12-lead ECG was performed at screening and at the end of the study. Pregnancy testing was performed according to applicable legislation in the country where the trial was performed. At the very least, women of childbearing potential had have to undergo a pregnancy test during screening for the study, before the first dose was applied and at the end of the study.

Being tested
Endoxana, IMA901, Leukine, IMA901 and Leukine
Keywords
clear cell renal cell carcinoma
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.

  • Endoxana, IMA901, LeukineDrug

    a single i.v. infusion of Cyclophosphamid and then patients received vaccination therapy with intradermal (i.d.) injections of GM-CSF followed by i.d. injections of IMA901

  • IMA901 and LeukineDrug

    Intradermal injection of GM-CSF followed by intradermal injection of IMA901

Study groups in NCT00523159
Study groupRoleWhat they receive
1OtherPre-treatment with a single low dose of Cyclophosphamide followed by IMA901 vaccination plus GM-CSF as adjuvant
Receives: Drug: Endoxana, IMA901, Leukine
2OtherNo pre-treatment with Cyclophosphamide before vaccination with IMA901 and GM-CSF as adjuvant
Receives: Drug: IMA901 and Leukine

What is being measured

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

  1. Disease control rate

    Measured: after 26 weeks

Secondary outcomes (9)

  1. Tumor response rates and SD rate

    Measured: after 26 and 38 weeks

  2. Duration of response

    Measured: from the time response is first documented until the first date of recurrence or PD

  3. Time to response

    Measured: From Visit c to PR or CR

  4. TTP

    Measured: From visit C to until tumor progression

  5. PFS and OS

    Measured: From visit C to tumor progression or death

  6. DCR

    Measured: after 38 weeks on study

  7. Immune response

    Measured: Visit C, 1, 5, 6, 7, 10 and 14

  8. Effect of cyclophosphamide pre-treatment on immune response

    Measured: Visit C, 1, 5,6,7, 10, 14

  9. Safety

    Measured: From inclusion on the study until 3 weeks after end of study visit

Timeline

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

  1. First posted31 Aug 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionAug 2009
  4. Study completionAug 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00523159
Sponsor's protocol ID
EudraCT Nr: 2006-006370-25
Acronym
IMA901-202
Status last verified
Feb 2010
First submitted
30 Aug 2007
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endoxana, IMA901, Leukine and IMA901 and Leukine in people with Renal Cell Carcinoma, run by Immatics Biotechnologies GmbH at 44 sites in 10 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 10 inclusion and 29 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Germany, Hungary, Romania, Slovakia, Spain and 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Disease control rate (time frame: after 26 weeks). 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 NCT00523159.

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 10 Jul 2012.

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