IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma

Completed · Phase 3

Conditions studied: Metastatic Renal Cell Carcinoma

In brief

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 standard first-line therapy with sunitinib. Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.

Key facts

Study ID

NCT01265901

Run by

Immatics Biotechnologies GmbH

People needed

339

Starts

2010-12-01

Expected to finish

2015-07-01

Last updated by the study team

2017-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• Kaiser Permanente Oncology Hematology Clinic — Denver, Colorado, United States
• Georgetown University Medical Center, Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• M.D. Anderson Cancer Center — Orlando, Florida, United States
• The University of Chicago Medicine — Chicago, Illinois, United States
• North Central Cancer Treatment Group, Illinois Cancer Care — Peoria, Illinois, United States
• IU Simon Cancer Center — Indianapolis, Indiana, United States
• Weinberg Cancer Institute at Franklin Hospital — Baltimore, Maryland, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Clinical Research Alliance — Lake Success, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic Taussig Cancer Institute — Cleveland, Ohio, United States
• UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology — Pittsburgh, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care — San Antonio, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Hôpital Saint André — Bordeaux, France
• Centre Francois Baclesse, Comite Urologie-Gynecologie — Caen, France
• CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire — Clermont-Ferrand, France
• Hospital Européen Georges Pompidou, Service d'oncologie medicale — Paris, France
• Centre Rene Gauducheau, Service d'oncologie medicale — Saint-Herblain, France
• Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz — Berlin, Germany
• Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH — Bochum, Germany
• Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn — Bonn, Germany
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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