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Sponsored by: |
immatics Biotechnologies GmbH |
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Information provided by: | immatics Biotechnologies GmbH |
ClinicalTrials.gov Identifier: | NCT00523159 |
This study is being 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 will receive vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Patients will receive pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination.
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Drug: Endoxana, IMA901, Leukine Drug: IMA901 and Leukine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 72 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
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1
Pre-treatment with a single low dose of Cyclophosphamide followed by IMA901 vaccination plus GM-CSF as adjuvant
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Drug: Endoxana, IMA901, Leukine
a single i.v. infusion of Cyclophosphamid and then patients will start vaccination therapy with intradermal (i.d.) injections of GM-CSF followed by i.d. injections of IMA901
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2
No pre-treatment with Cyclophosphamide before vaccination with IMA901 and GM-CSF as adjuvant
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Drug: IMA901 and Leukine
Intradermal injection of GM-CSF followed by intradermal injection of IMA901
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This is a multicenter, open label, randomized phase 2 study which will investigate the effect of a second-line systemic treatment with IMA901 plus GM-CSF in RCC patients. Randomization will be done according to a pre-treatment with low-dose cyclophosphamide (CY). Secondary endpoints comprise tumor response parameters.
The study population consists 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 must be aged 18 years or older, have at least one measurable tumor lesion and must have received first-line tyrosine kinase inhibitor or cytokine systemic therapy for advanced disease, during or after which the patient experienced disease progression.
Patients in both arms will receive a total of 17 vaccinations with GM-CSF followed by IMA901 during the 9 month treatment period.
At screening baseline tumor status will be assessed by CT or MRI. During the study tumor assessments will be 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 will be assessed on several occasions during the study.
Safety assessment will comprise continuous adverse event reporting, regular physical examinations and regular assessments of vital signs, hematology, blood chemistry and urine. A 12-lead ECG will be performed at screening and at the end of the study. Pregnancy testing will be performed according to applicable legislation in the country where the trial is being performed. At the very least, women of childbearing potential must undergo a pregnancy test during screening for the study, before the first dose and at the end of the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following in the 4 weeks before study entry:
Any of the following abnormal laboratory values:
Patients with other significant diseases currently uncontrolled by treatment which might interfere with study completion, for example:
Contact: Alexandra Kirner, PhD | 49-0-7071-565125 ext 42 | kirner@immatics.com |
Contact: Juergen Frisch, MD | 49-0-7071-565125 ext 13 | frisch@immatics.com |
Study Director: | Alexandra Kirner, PhD | immatics Biotechnologies GmbH |
Study ID Numbers: | EudraCT Nr: 2006-006370-25 |
Study First Received: | August 30, 2007 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00523159 |
Health Authority: | Germany: Paul-Ehrlich-Institut; Austria: Agency for Health and Food Safety; Bulgaria: Bulgarian Drug Agency; Hungary: National Institute of Pharmacy; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; Romania: State Institute for Drug Control; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Switzerland: Swissmedic |
clear cell renal cell carcinoma |
Urogenital Neoplasms Cyclophosphamide Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |