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
- 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).MedDRA version: 9.1 Level: LLT Classification code 10038407 Term: Renal cell cancer
- Registration Number
- EUCTR2006-006370-25-GB
- Lead Sponsor
- immatics biotechnologies GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
c. Corrected serum calcium = 10 mg/dL
9.Able to understand the nature of the study and give written informed consent
10.Willingness and ability to comply with the study protocol for the duration of the study
*NOTE: in Germany and Austria only patients after first-line tyrosine kinase inhibitor failure will be included into the study as per amendment no. 1 and no. 2
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
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.
11)Any of the following in the 4 weeks before Visit C:
a)Major surgery
b)Anticancer treatments including (but not limited to) cytotoxic chemotherapy, radiotherapy, immunotherapy, hormone therapy, tyrosine kinase inhibitors, monoclonal antibodies
c)Unresolved toxicity from prior anticancer treatments including (but not limited to) cytotoxic chemotherapy, hormone therapy, tyrosine kinase inhibitors, monoclonal antibodies, radiotherapy, or immunotherapy
d)Received study drug within any clinical study (including approved and experimental drugs)
12)Any of the following abnormal laboratory values:
a)Hematology: Hb < 9 g/dL; WBC < 3 x 10^9/L; neutrophils < 1.5 x 10^9/L; lymphocytes < 1.0 x 10^9/L; platelets < 100 x 10^9/L
b)Liver function: serum bilirubin > 1.5 x upper normal limit (unless a history of Gilbert’s disease); ALAT or ASAT > 3 x upper normal limit (>5 x upper normal limit if liver metastases are present)
c)Renal function: serum creatinine > 200 µmol/L
13)Patients with other significant diseases currently uncontrolled by treatment which might interfere with study completion, including gastrointestinal, hepatic, renal, respiratory, cardiovascular, hematological, coagulation, metabolic or hormonal diseases with clinically relevant abnormal organ function for example:
a)Heart failure or non compensated active heart disease (= New York Heart Association III, see Appendix 2 of the protocol)
b)Severe coronary heart disease, cardiac arrhythmia requiring medication, or uncontrolled hypertension
c)Symptomatic neurotoxicity (motor or sensory) = grade 2 National Cancer Institute – Common Toxicity Criteria (NCI-CTC).d)Severe pulmonary dysfunction
14)Psychiatric disabilities, seizures or central nervous system disorders that may interfere with the ability to give informed consent or perform adequate follow-up in the investigator’s opinion
15) Active infections requiring oral or intravenous antibiotics
16)Women or men who decline to practice a medically approved method of contraception
17)Pregnancy or breastfeed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method