Status:
COMPLETED
IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
Lead Sponsor:
Immatics Biotechnologies GmbH
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to ...
Detailed Description
This is a multicenter, open-label, randomized phase III study to investigate whether therapeutic vaccination with IMA901, a mult-peptide cancer vaccine (TUMAP), can prolong overall survival in patient...
Eligibility Criteria
Inclusion
- Aged at least 18 years.
- HLA type: HLA-A\*02-positive
- Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required.
- Measurable and/or non-measurable tumor lesions as per RECIST 1.1
- Patients who are candidates for a first-line therapy with sunitinib.
- Favorable or intermediate risk according to the 6-score risk criteria in patients treated with VEGF-targeted agents according to Heng \[Heng et al. 2009\]. 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):
- Hemoglobin \< LLN,
- Serum corrected calcium \> ULN,
- Karnofsky performance status \< 80%,
- Time from initial diagnosis to initiation of therapy \< 1 year,
- Absolute neutrophil count \> ULN,
- Platelets \> ULN.
- 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.
- 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 a medically acceptable method of birth control.
- Male patients willing to use contraception (upon study entry and during the course of the study or have undergone vasectomy.
Exclusion
- 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).
- History of or current brain metastases.
- Abnormal ≥ CTC Grade 3 laboratory values for hematology (Hb, WBC, neutrophils, lymphocytes, platelets), liver (serum bilirubin, ALAT or ASAT) and renal function (serum creatinine).
- Metastatic second malignancy.
- Localized second malignancy expected to influence the patient's life span.
- 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.
- Known active hepatitis B or C infection.
- Known HIV infection.
- Active infections requiring oral or intravenous antibiotics.
- 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.
- Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start.
- 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.
- 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).
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT01265901
Start Date
December 1 2010
End Date
July 1 2015
Last Update
October 12 2017
Active Locations (105)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
3
Kaiser Permanente Oncology Hematology Clinic
Denver, Colorado, United States, 80205
4
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007