Evaluation of a New Anti-cancer Vaccine for Patients With Non-small Cell Lung Cancer, After Tumor Removal by Surgery
NCT ID: NCT01159964
Last Updated: 2018-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
60 participants
INTERVENTIONAL
2010-07-20
2014-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Subjects will receive investigational dose-level A (different from dose-levels B and C). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
Immunotherapeutic GSK2302032A, different formulations
Intramuscular administration
Cohort 2
Subjects will receive investigational dose-level B (different from dose-levels A and C). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
Immunotherapeutic GSK2302032A, different formulations
Intramuscular administration
Cohort 3
Subjects will receive investigational dose-level C (different from dose-levels A and B). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
Immunotherapeutic GSK2302032A, different formulations
Intramuscular administration
Interventions
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Immunotherapeutic GSK2302032A, different formulations
Intramuscular administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent for PRAME gene expression screening on resected tumor tissue has been obtained from the patient prior to shipment of the sample for expression testing, and written informed consent for the complete study participation has been obtained before the performance of any other protocol specific procedure.
3. Patient is \>= 18 years of age at the time of signature of the first informed consent form.
4. The patient's tumor shows expression of the PRAME gene.
5. The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy. The first ASCI administration will be given, either within 12 weeks after surgery or within 8 weeks after day 1 of last chemotherapy cycle and within 32 weeks after resection.
6. The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest and upper abdomen as well as CT scan or magnetic resonance imaging (MRI) of the brain. These tests are to be performed within 6 weeks for the CT scan of the chest and upper abdomen and within 12 weeks for the brain CT scan or MRI before first ASCI administration.
7. ECOG performance status of 0, 1 or 2.
8. Adequate bone-marrow reserve, renal, adrenal and hepatic function as assessed by standard laboratory criteria
9. Female patients of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal-ligation, hysterectomy, ovariectomy or post-menopause.
10. Female patient of childbearing potential may be enrolled in the study, if the patient:
* has practiced adequate contraception for 30 days prior to study product administration, and
* has a negative pregnancy test on the day of administration, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study product administration series.
11. In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Exclusion Criteria
2. The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except for the treatment of previous malignancies allowed by the protocol.
3. The patient requires concomitant treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
4. Use of any investigational or non-registered product (drug or vaccine, except influenza vaccine in the context of H1N1 mass-vaccination) other than the study product within the 30 days preceding the first dose of study product, or planned use during the study period.
5. The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for more than 3 years and highly likely to have been cured.
6. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
7. History of confirmed adrenal dysfunction.
8. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
9. The patient has received a major organ allograft.
10. The patient is known to be Human Immunodeficiency Virus (HIV) -positive.
11. The patient has an uncontrolled bleeding disorder.
12. The patient has uncontrolled congestive heart failure or uncontrolled hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
13. The patient needs home oxygenation.
14. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
15. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
16. For female patients: the patient is pregnant or lactating.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Newark, Delaware, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Rochester, Minnesota, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Everett, Washington, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nice, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Toulouse, , France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Regensburg, Bavaria, Germany
GSK Investigational Site
Regensburg, Bavaria, Germany
GSK Investigational Site
Immenhausen, Hesse, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Moers, North Rhine-Westphalia, Germany
GSK Investigational Site
Velbert, North Rhine-Westphalia, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Meldola (FC), Emilia-Romagna, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Pisa, Tuscany, Italy
GSK Investigational Site
Perugia, Umbria, Italy
GSK Investigational Site
Chęciny, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Szczecin, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Zakopane, , Poland
GSK Investigational Site
Chelyabinsk, , Russia
GSK Investigational Site
Kazan', , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
Countries
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References
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Pujol JL, De Pas T, Rittmeyer A, Vallieres E, Kubisa B, Levchenko E, Wiesemann S, Masters GA, Shen R, Tjulandin SA, Hofmann HS, Vanhoutte N, Salaun B, Debois M, Jarnjak S, De Sousa Alves PM, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of the PRAME Cancer Immunotherapeutic in Patients with Resected Non-Small Cell Lung Cancer: A Phase I Dose Escalation Study. J Thorac Oncol. 2016 Dec;11(12):2208-2217. doi: 10.1016/j.jtho.2016.08.120. Epub 2016 Aug 17.
Other Identifiers
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113174
Identifier Type: -
Identifier Source: org_study_id
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