A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma - IMA in patients receiving sunitinib for advanced metastatic RCC

IMMATICS BIOTECHNOLOGIES GMBH0 sites330 target enrollmentJune 14, 2011

DrugsENDOXAN BAXTER*EV 1FL 1G Leukine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: IMMATICS BIOTECHNOLOGIES GMBH
Enrollment: 330
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 14, 2011

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

IMMATICS BIOTECHNOLOGIES GMBH

Eligibility Criteria

Inclusion Criteria

•1\. Aged at least 18 years. 2\. HLA type: HLA\-A\*02\-positive (assessed by a central laboratory, the result of HLA\-testing will be available within a maximum of 5 days). 3\. Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required. 4\. Measurable and/or non\-measurable tumor lesions as per RECIST 1\.1 based on the local assessment. 5\. Patients who are candidates for a first\-line therapy with sunitinib. 6\. 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]. Laboratory values for risk categorization will be determined by a central laboratory. 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): a. Hemoglobin \< LLN, b. Serum corrected calcium \> ULN, c. Karnofsky performance status \< 80%, d. Time from initial diagnosis to initiation of therapy \< 1 year, e. Absolute neutrophil count \> ULN, f. Platelets \> ULN. 7\. Able to understand the nature of the study and give written informed consent. 8\. Willingness and ability to comply with the study protocol for the duration of the study. 9\. 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 one of the following medically acceptable methods of birth control: • Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient’s usual menstrual cycle period) before study entry. • Intrauterine device (IUD). • Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream). 10\. Male patients willing to use contraception (condoms with spermicidal jellies or cream) upon study entry and during the course of the study or have undergone vasectomy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\. 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). 2\. History of or current brain metastases. 3\. Abnormal \= CTC Grade 3 laboratory values at Screening 2 (assessed by a central laboratory) for hematology (Hb, WBC, neutrophils, lymphocytes, platelets), liver (serum bilirubin, ALAT or ASAT) and renal function (serum creatinine). 4\. Metastatic second malignancy. 5\. Localized second malignancy expected to influence the patient’s life span. 6\. Patients with a history or evidence of systemic autoimmune disease, e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sj?gren\`s syndrome, Wegener\`s granulomatosis, Guillain\-Barre syndrome. 7\. Known active hepatitis B or C infection. 8\. Known HIV infection. 9\. Active infections requiring oral or intravenous antibiotics. 10\. 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. Examples are: rabies, Mycobacterium leprae, Plasmodium falciparum, Coccidiodes immitis. 11\. Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start. 12\. 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, • Severe pulmonary dysfunction, • Psychiatric illness or social situation that would preclude study compliance. 13\. Less than 12 months since any of the following: • Myocardial infarction, • Severe or unstable angina, • Coronary or peripheral artery bypass graft, • Cerebrovascular event incl. transient ischemic attack, • Pulmonary embolism / deep vein thrombosis (DVT). 14\. Pregnancy or breastfeeding. 15\. Any condition which in the judgment of the investigator would place the patient at undue risk or interfere with the results of the study.