Phase 2, randomised, open label, multicenter study of intradermal IMA901 plus GM-CSF with or without low dose cyclophosphamide pre-treatment in advanced renal cell carcinoma patients with measurable disease

immatics biotechnologies GmbH0 sites0 target enrollmentMay 15, 2007

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HLA-A*02-positive patients with advanced clear cell RCC who have progressed during or after first-line systemic therapy for advanced disease and have a favourable or intermediate risk after systemic therapy according to the 3-score risk cc prognostic risk category (Motzer 2004).
Sponsor: immatics biotechnologies GmbH
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

May 15, 2007

End Date

August 24, 2009

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Aged at least 18 years
•2\.HLA type: HLA\-A\*02\-positive
•3\.Histologically documented advanced clear\-cell RCC
•4\.Patients who have received first\-line tyrosine kinase inhibitor or cytokine systemic therapy for advanced disease and are candidates for second\-line therapy. Patients who have received treatment with two sequential tyrosine kinase inhibitors are also accepted.\*
•5\.Patients having experienced documented tumor progression during or after previous systemic therapy. Documentation of progression must be either imaging based (i.e. any increase in lesion size and/or an increase in the number of tumor lesions) or based on clinical (symptomatic) tumor progression.
•6\.At least one unidimensional measurable target lesion documented by adequate imaging and assessable according to the RECIST criteria, whereby target lesions must not lie in a previously irradiated area
•7\.Karnofsky Performance Status lower than 80
•8\.Favorable or intermediate risk according to the 3\-score MSKCC criteria (see Section 4\.5\.3 of the protocol). The subject has a favorable risk if none, or intermediate risk if only one of the following criteria applies (if two or three criteria apply the subject is not eligible):
•a. Karnofsky performance status lower than 80
•b. Serum haemoglobin \= 13 g/dL for males and \= 11\.5 g/dL for females

•1\)Poor risk according to the 3\-score MSKCC criteria (see Section 4\.5\.3 of the protocol).
•2\)Immunosuppressive therapy within 4 weeks before Visit C, e.g. corticosteroid treatment (exceptions are corticosteroid substitution therapy for adrenal insufficiency or inhalative corticosteroids for e.g. asthma)
•3\)History of other malignant tumors, except basal cell carcinoma or curatively excised cervical carcinoma in situ
•4\)Presence of brain metastases on MRI or CT scan
•5\)Patients with a history or evidence of systemic autoimmune disease
•6\)Any vaccination in the two weeks before Visit C
•7\)Any planned prophylactic vaccination from study entry until the end of the induction period (5 weeks after the first vaccination)
•8\)Known active hepatitis B or C infection
•9\)Known HIV infection
•10\)Any other infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patient tissues. Examples are: rabies, mycobacterium tuberculosis, coccidiodes immitis.