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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000213-30-DE
Enrollment
20
Registered
2008-02-25
Start date
2008-04-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Product Name: IMA901 Pharmaceutical Form: Powder for solution for injection Trade Name: Leukine Product Name: Leukine (GM-CSF) Pharmaceutical Form: Powder for solution for injection

Sponsors

immatics biotechnologies GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026