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

Phase 1

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.
MedDRA version: 14.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-022459-45-HU

Lead Sponsor: immatics biotechnologies GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 339

Inclusion Criteria

1.Aged at least 18 years
2.HLA type: HLA-A*02-positive
3.Metastatic and/or locally advanced RCC with clear cell histology 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
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

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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1.Prior systemic therapy for metastatic disease.
2.History of or current brain metastases.
3.Abnormal = CTC Grade 3 laboratory values at screening 2 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
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.
11.Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start
12.Serious intercurrent illness
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the present 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 Objective: Secondary objectives include a subgroup analysis of overall survival in patients who are positive for a prospectively defined primary biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters (in a subset of patients).<br>Further objectives are additional biomarker analyses.<br>;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: continuously

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Overall survival in patients who are positive for the prospectively<br>defined primary biomarker signature <br>• Progression-free survival (PFS) <br>• Best tumor response <br>• Safety and tolerability of IMA901 <br>• Cellular immunomonitoring;Timepoint(s) of evaluation of this end point: see protocol

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