IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease

NCT00523159 | Completed Phase 2 DMC

• 1 other identifier: EudraCT Nr: 2006-006370-25
• Study Type: interventional
• Target: 68
• Locations: 10 countries
• Sites: 44

Brief 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. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination.

Conditions

Renal Cell Carcinoma

Keywords

clear cell renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  after 26 weeks

Secondary Outcomes (9)

• Tumor response rates and SD rate

  after 26 and 38 weeks

• Duration of response

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

• Time to response

  From Visit c to PR or CR

• TTP

  From visit C to until tumor progression

• PFS and OS

  From visit C to tumor progression or death

Study Arms (2)

1

OTHER

Pre-treatment with a single low dose of Cyclophosphamide followed by IMA901 vaccination plus GM-CSF as adjuvant

Drug: Endoxana, IMA901, Leukine

2

OTHER

No pre-treatment with Cyclophosphamide before vaccination with IMA901 and GM-CSF as adjuvant

Drug: IMA901 and Leukine

Interventions

Endoxana, IMA901, Leukine DRUG

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

1

IMA901 and Leukine DRUG

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

2

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
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Immatics Biotechnologies GmbH: lead

Study Sites (44)

Medizinische Universität Salzburg - Universitätsklinik für Innere Medizin III

Salzburg, 5020, Austria

Location

National Oncology Hospital - Urology

Sofia, 1233, Bulgaria

Location

Regional Oncodispensary with inpatient sector-Sofia District

Sofia, 1233, Bulgaria

Location

Charité Campus Mitte-Klinik für Urologie

Berlin, 10117, Germany

Location

Charité Campus Benjamin Franklin - Medizinische Klinik III

Berlin, 12203, Germany

Location

Zeisigwaldkliniken Bethanien Chemnitz GmbH

Chemnitz, 09130, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Klinik der Johann-Wolfgang-Goethe-Universität

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum (Onkologie / Hämatologie)

Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg - Klinik für Urologie

Heidelberg, 69120, Germany

Location

Universitätsklinikum Schleswig Holstein - Campus Lübeck

Lübeck, 23538, Germany

Location

Universitätsklinikum Mainz - 3. Medizinische Klinik

Mainz, 55131, Germany

Location

Klinikum der Universität - München Großhadern

Munich, 81377, Germany

Location

Urologische Klinik Dr. Castringius - München-Planegg

Planegg, 82152, Germany

Location

Universitätsklinikum Tübingen - Klinik für Urologie

Tübingen, 72076, Germany

Location

Schwarzwald-Baar-Klinik - Abt. Hämatologie und Onkologie

Villingen-Schwenningen, 78050, Germany

Location

DRC Gyógyszervizsgáló Központ Kft

Balatonfüred, 8230, Hungary

Location

Semmelweis Egyetem - Urológiai Klinika

Budapest, 1082, Hungary

Location

Bajcsy-Zsilinszky Kórház - Urológia Osztály

Budapest, 1106, Hungary

Location

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

Budapest, 1115, Hungary

Location

Országos Onkológiai Intézet - Kemoterápia C osztály-Klinikofarmakológia

Budapest, 1122, Hungary

Location

Debreceni Egyetem Orvos és Egészségtudományi Centrum

Debrecen, 4012, Hungary

Location

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

Debrecen, 4043, Hungary

Location

BAZ megyei Kórház - Urológia Osztály

Miskolc, 3501, Hungary

Location

Pécs Orvostudomanyi Egyetem - Urológiai Klinika

Pécs, 7621, Hungary

Location

Klinika Chemioterapii Nowotworow - Uniwersytetu Medycznego

Lodz, 93509, Poland

Location

Klinika Onkologii Wojskowego Institutu Medycznego

Warsaw, 00909, Poland

Location

Clinic of Urology and Urological Oncology Medica University Hospital

Wroclaw, 50-043, Poland

Location

Oncology Institute "Prof. Dr. Alexandru Trestioreanu"

Bucharest, 022328, Romania

Location

Oncology Institute - "Prof. Dr. Alexandru Trestioreanu"

Bucharest, 022328, Romania

Location

Oncology Institute "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, 400015, Romania

Location

Clinical County Hospital Oradea

Oradea, 4170167, Romania

Location

National Cancer Institut - "Narodny onkologicky ustav"

Bratislava, 83310, Slovakia

Location

Clinic of Radiotherapy and Oncology - East Slovak Oncology Institute

Košice, 04191, Slovakia

Location

Martin Faculty Hospital

Martin, 03659, Slovakia

Location

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

Prešov, 08181, Slovakia

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28035, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Universitaria de Navarra - Servicio de Oncologia

Pamplona, 31008, Spain

Location

University Hospital - Medicine Oncology

Geneva, 1211, Switzerland

Location

Beatson Oncology Centre

Glasgow, G11 6NT, United Kingdom

Location

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

Manchester, M20 4BX, United Kingdom

Location

University of Surrey - Postgraduate Medical School

Surrey, GU2 7WG, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

sargramostim

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

Study Officials

• Alexandra Kirner, PhD

  Immatics Biotechnologies GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 10, 2012

Record last verified: 2010-02

Locations

ES (4); CH (1); AU (1); GB (3); RO (4); BU (2); SL (4); HU (9); DE (13); PL (3)