Clinical trial NCT01159964: Evaluation of a New Anti-cancer Vaccine for Patients With Non-small Cell Lung Cancer, After Tumor Removal by Surgery
Official title: Study of GSK2302032A Antigen-Specific Cancer Immunotherapeutic in Patients With Resectable Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lung Cancer, Non-Small Cell
Keywords: Antigen-Specific Cancer Immunotherapeutic (ASCI)
PRAME
PRAME-positive stage IB, II or IIIA Non-Small Cell Lung Cancer patients after complete surgical resection
Non-Small Cell Lung Cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to assess the safety and immunogenicity of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.


Eligibility criteria: Inclusion Criteria:

1. Male or female patient with completely resected (R0 resection), pathologically proven stage IB, II or IIIA NSCLC. Patients are allowed to receive adjuvant platinum-based chemotherapy for the treatment of the current NSCLC between surgery and enrolment.
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:

1. The primary tumor was removed by segmentectomy or wedge resection.
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.

Primary outcomes:
measure: Occurrence of dose-limiting toxicities during study treatment
timeFrame: During the study treatment period (up to 112 weeks, approximately 2 years and 2 months)
measure: Occurrence of dose-limiting toxicities during study follow-up
timeFrame: 12 months after concluding visit (week 112)
measure: Anti-PRAME humoral immune response
timeFrame: Assessed post-dose 4 (Week 12)
measure: Anti-PRAME humoral immune response
timeFrame: Throughout the study (Day 0 until 12 months after concluding visit (week 112))
Secondary outcomes:
measure: Occurrence of adverse events (AEs) and serious adverse events
timeFrame: During the whole study treatment period until 30 days after the last treatment administration.
measure: The anti-PRAME cellular (T-cell) response
timeFrame: At 6 defined time-points during the study (Week 0, 12, 24, 72 and 112) and follow-up period (6 months later).
measure: The anti-PRAME humoral immunogenicity
timeFrame: At 10 defined timepoints during the study (Week 0, 6, 12, 24, 48, 72, 96, 112), and follow-up period (6 and 12 months later).
Other outcomes:
Locations:
city: Newark
country: United States
facility: GSK Investigational Site
state: Delaware
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Everett
country: United States
facility: GSK Investigational Site
state: Washington
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Montpellier
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Paris Cedex 12
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Immenhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Moers
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Meldola (FC)
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Checiny
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Zakopane
country: Poland
facility: GSK Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.