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 - IMA901 in patients receiving sunitinib for advanced/metastatic RCC

immatics biotechnologies GmbH0 sites339 target enrollmentApril 15, 2011

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: The study population consists of HLA-A*02-positive metastatic and/or locally advanced RCC patients with histology of the clear-cell type who are aged 18 years or older and have a favorable or intermediate risk according to the 6-score Heng criteria (Heng et al, 2009). Patients must be planned to receive standard first-line therapy with sunitinib irrespective of their participation in the trial.
Sponsor: immatics biotechnologies GmbH
Enrollment: 339
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

April 15, 2011

End Date

July 28, 2015

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 subject 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 subject 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

•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, Sjögren'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 patient tissues. Examples are: rabies, mycobacterium leprae, plasmodium falciparum, coccidiodes immitis.