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IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Completed Renal Cell Carcinoma immatics Biotechnologies GmbH Industry August 30, 2007 July 9, 2012 February 2010

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment Phase 2 68 May 2007 -

Locations

FacilityAddressContactPhoneEmailStatus
Medizinische Universität Salzburg - Universitätsklinik für Innere Medizin III Salzburg 5020 Austria - - - -
Regional Oncodispensary with inpatient sector-Sofia District Sofia 1233 Bulgaria - - - -
National Oncology Hospital - Urology Sofia 1233 Bulgaria - - - -
Charité Campus Mitte-Klinik für Urologie Berlin 10117 Germany - - - -
Charité Campus Benjamin Franklin - Medizinische Klinik III Berlin 12203 Germany - - - -
Zeisigwaldkliniken Bethanien Chemnitz GmbH Chemnitz 09130 Germany - - - -
Universitätsklinikum Essen Essen 45122 Germany - - - -
Klinik der Johann-Wolfgang-Goethe-Universität Frankfurt / Main 60590 Germany - - - -
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum (Onkologie / Hämatologie) Hamburg 20246 Germany - - - -
Universitätsklinikum Heidelberg - Klinik für Urologie Heidelberg 69120 Germany - - - -
Universitätsklinikum Schleswig Holstein - Campus Lübeck Lübeck 23538 Germany - - - -
Universitätsklinikum Mainz - 3. Medizinische Klinik Mainz 55131 Germany - - - -
Klinikum der Universität - München Großhadern Munich 81377 Germany - - - -
Urologische Klinik Dr. Castringius - München-Planegg Planegg 82152 Germany - - - -
Universitätsklinikum Tübingen - Klinik für Urologie Tuebingen 72076 Germany - - - -
Schwarzwald-Baar-Klinik - Abt. Hämatologie und Onkologie Villingen-Schwenningen 78050 Germany - - - -
DRC Gyógyszervizsgáló Központ Kft Balatonfüred 8230 Hungary - - - -
Semmelweis Egyetem - Urológiai Klinika Budapest 1082 Hungary - - - -
Bajcsy-Zsilinszky Kórház - Urológia Osztály Budapest 1106 Hungary - - - -
Fövárosi Önk.Szt.Imre Kórház - Belgyógyászat-Kliniko-FFarmakológia Budapest 1115 Hungary - - - -
Országos Onkológiai Intézet - Kemoterápia C osztály-Klinikofarmakológia Budapest 1122 Hungary - - - -
Debreceni Egyetem Orvos és Egészségtudományi Centrum Debrecen 4012 Hungary - - - -
Hajdú-Bihar Megyei Önk. Kenézy Gyula Kórház/Urológia Osztály Debrecen 4043 Hungary - - - -
BAZ megyei Kórház - Urológia Osztály Miskolc 3501 Hungary - - - -
Pécs Orvostudomanyi Egyetem - Urológiai Klinika Pécs 7621 Hungary - - - -
Klinika Chemioterapii Nowotworow - Uniwersytetu Medycznego Lodz 93509 Poland - - - -
Klinika Onkologii Wojskowego Institutu Medycznego Warszawa 00909 Poland - - - -
Clinic of Urology and Urological Oncology Medica University Hospital Wroclaw 50-043 Poland - - - -
Oncology Institute - "Prof. Dr. Alexandru Trestioreanu" Bucharest 022328 Romania - - - -
Oncology Institute "Prof. Dr. Alexandru Trestioreanu" Bucharest 022328 Romania - - - -
Oncology Institute "Prof. Dr. Ion Chiricuta" Cluj-Napoca 400015 Romania - - - -
Clinical County Hospital Oradea Oradea 4170167 Romania - - - -
National Cancer Institut - "Narodny onkologicky ustav" Bratislava 83310 Slovakia - - - -
Clinic of Radiotherapy and Oncology - East Slovak Oncology Institute Kosice 04191 Slovakia - - - -
Martin Faculty Hospital Martin 03659 Slovakia - - - -
Department of Clinical Oncology - Faculty Hospital with Policlinic of J.A. Reiman Presov 08181 Slovakia - - - -
Hospital Universitari Vall d'Hebron Barcelona 08035 Spain - - - -
Hospital Universitario Puerta de Hierro Madrid 28035 Spain - - - -
Hospital 12 de Octubre Madrid 28041 Spain - - - -
Clinica Universitaria de Navarra - Servicio de Oncologia Pamplona 31008 Spain - - - -
University Hospital - Medicine Oncology Geneva 1211 Switzerland - - - -
Beatson Oncology Centre Glasgow G11 6NT United Kingdom - - - -
Christie Hospital NHS Trust, CRUK Department of Medical Onkology - Paterson Institute for Cancer Research Manchester M20 4BX United Kingdom - - - -
University of Surrey - Postgraduate Medical School Surrey GU2 7WG United Kingdom - - - -

Intervention

TypeInterventionDescription
Drug Endoxana, IMA901, Leukine 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
Drug IMA901 and Leukine Intradermal injection of GM-CSF followed by intradermal injection of IMA901

Outcome

TypeMeasureTime FrameSafety Issue
Primary Disease control rate after 26 weeks No
Secondary Tumor response rates and SD rate after 26 and 38 weeks No
Secondary Duration of response from the time response is first documented until the first date of recurrence or PD No
Secondary Time to response From Visit c to PR or CR No
Secondary TTP From visit C to until tumor progression No
Secondary PFS and OS From visit C to tumor progression or death No
Secondary DCR after 38 weeks on study No
Secondary Immune response Visit C, 1, 5, 6, 7, 10 and 14 No
Secondary Effect of cyclophosphamide pre-treatment on immune response Visit C, 1, 5,6,7, 10, 14 No
Secondary Safety From inclusion on the study until 3 weeks after end of study visit Yes

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

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.

Eligibility

GenderMinimum AgeMaximum AgeHealthy Volunteers
Both - N/A No

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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:

1. Major surgery

2. Anticancer treatments including (but not limited to) cytotoxic chemotherapy,
radiotherapy, immunotherapy, hormone therapy, tyrosine kinase inhibitors,
monoclonal antibodies

3. Unresolved toxicity from prior anticancer treatments including (but not limited
to) cytotoxic chemotherapy, hormone therapy, tyrosine kinase inhibitors,
monoclonal antibodies, radiotherapy, or immunotherapy

4. Received study drug within any clinical study

- Any of the following abnormal laboratory values:

1. 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

2. 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)

3. Renal function: serum creatinine > 200 µmol/L

- Patients with other significant diseases currently uncontrolled by treatment which
might interfere with study completion, for example:

1. Heart failure or non compensated active heart disease

2. Severe coronary heart disease, cardiac arrhythmia requiring medication, or
uncontrolled hypertension

3. Symptomatic neurotoxicity (motor or sensory) ≥ grade 2 National Cancer Institute
- Common Toxicity Criteria (NCI-CTC).

4. 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