Extension study to evaluate long-term-safety of IMA901 plus GM-CSF in advanced renal cell carcinoma patients who achieved a decrease in tumor load or stabilization of their disease after participation in the open-label, multicenter IMA901-202 Phase 2 study

Conditions: This extension study will be conducted in men and women with advanced renal cell cancer (RCC) who achieved a decrease in tumor load or stabilization of their disease after participation in the core study IMA901-202.

Registration Number: EUCTR2008-000213-30-DE

Lead Sponsor: immatics biotechnologies GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1. Patients who have participated in the core study IMA901-202 over the entire scheduled period and were compliant with the protocol
2. Patients who achieved a decrease in tumor load or stabilization of their disease after participation in the core study IMA901-202
3. Ability to understand the nature of the study and to give written informed consent
4. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Non compliance in the conduct of the IMA901-202 study
2. Women or men who decline to practice a medically approved method of contraception
3. Pregnancy or breastfeeding
4. Any condition which in the judgement of the investigator would place the patient at undue risk

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 extension study is to investigate the sustained safety of IMA901 plus GM-CSF (adjuvant) as single agent in advanced renal cell carcinoma patients who achieved a decrease in tumor load or stabilization of their disease after participation in the core study IMA901-202.;Secondary Objective: Secondary objectives of this study are efficacy, overall survival and immunological parameters.;Primary end point(s): The primary endpoint of this extension study is long-term safety with Visit B of core study IMA901-202 being the reference point.

Secondary Outcome Measures