Evaluation of a New Anti-cancer Vaccine for Patients With Non-small Cell Lung Cancer, After Tumor Removal by Surgery

NCT01159964 | Terminated Phase 1

• 1 other identifier: 113174
• Study Type: interventional
• Target: 60
• Locations: 6 countries
• Sites: 37

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.

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

Outcome Measures

Primary Outcomes (4)

• Occurrence of dose-limiting toxicities during study treatment

  During the study treatment period (up to 112 weeks, approximately 2 years and 2 months)

• Occurrence of dose-limiting toxicities during study follow-up

  12 months after concluding visit (week 112)

• Anti-PRAME humoral immune response

  Assessed post-dose 4 (Week 12)

• Anti-PRAME humoral immune response

  Throughout the study (Day 0 until 12 months after concluding visit (week 112))

Secondary Outcomes (3)

• Occurrence of adverse events (AEs) and serious adverse events

  During the whole study treatment period until 30 days after the last treatment administration.

• The anti-PRAME cellular (T-cell) response

  At 6 defined time-points during the study (Week 0, 12, 24, 72 and 112) and follow-up period (6 months later).

• The anti-PRAME humoral immunogenicity

  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).

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Biological: Immunotherapeutic GSK2302032A, different formulations

Cohort 2

EXPERIMENTAL

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

Biological: Immunotherapeutic GSK2302032A, different formulations

Cohort 3

EXPERIMENTAL

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

Biological: Immunotherapeutic GSK2302032A, different formulations

Interventions

Immunotherapeutic GSK2302032A, different formulations BIOLOGICAL

Intramuscular administration

Also known as: PRAME ASCI

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patient is \>= 18 years of age at the time of signature of the first informed consent form.
• The patient's tumor shows expression of the PRAME gene.
• 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.
• 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.
• ECOG performance status of 0, 1 or 2.
• Adequate bone-marrow reserve, renal, adrenal and hepatic function as assessed by standard laboratory criteria
• 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.
• 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.
• In the view of the investigator, the patient can and will comply with the requirements of the protocol.

You may not qualify if:

• The primary tumor was removed by segmentectomy or wedge resection.
• 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.
• The patient requires concomitant treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
• 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.
• 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.
• History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
• History of confirmed adrenal dysfunction.
• 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.
• The patient has received a major organ allograft.
• The patient is known to be Human Immunodeficiency Virus (HIV) -positive.
• The patient has an uncontrolled bleeding disorder.
• 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.
• The patient needs home oxygenation.
• The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (37)

GSK Investigational Site

Newark, Delaware, 19713, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Everett, Washington, 98201, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Montpellier, 34295, France

Location

GSK Investigational Site

Nice, 06002, France

Location

GSK Investigational Site

Paris, 75571, France

Location

GSK Investigational Site

Toulouse, 31052, France

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81925, Germany

Location

GSK Investigational Site

Regensburg, Bavaria, 93049, Germany

Location

GSK Investigational Site

Regensburg, Bavaria, 93053, Germany

Location

GSK Investigational Site

Immenhausen, Hesse, 34376, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 51109, Germany

Location

GSK Investigational Site

Moers, North Rhine-Westphalia, 47441, Germany

Location

GSK Investigational Site

Velbert, North Rhine-Westphalia, 42551, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04129, Germany

Location

GSK Investigational Site

Berlin, 13125, Germany

Location

GSK Investigational Site

Meldola (FC), Emilia-Romagna, 47014, Italy

Location

GSK Investigational Site

Rome, Lazio, 00152, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20141, Italy

Location

GSK Investigational Site

Pisa, Tuscany, 56100, Italy

Location

GSK Investigational Site

Perugia, Umbria, 06156, Italy

Location

GSK Investigational Site

Chęciny, 26-060, Poland

Location

GSK Investigational Site

Lublin, 20-954, Poland

Location

GSK Investigational Site

Szczecin, 70-891, Poland

Location

GSK Investigational Site

Warsaw, 04-125, Poland

Location

GSK Investigational Site

Zakopane, 34-500, Poland

Location

GSK Investigational Site

Chelyabinsk, 454087, Russia

Location

GSK Investigational Site

Kazan', 420029, Russia

Location

GSK Investigational Site

Moscow, 115478, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Saint Petersburg, 197758, Russia

Location

Related Publications (1)

• 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.

  PMID: 27544054 DERIVED

Related Links

• Results for study 113174 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: July 20, 2010
• Primary Completion: October 19, 2011
• Study Completion: September 10, 2014
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

RU (5); IT (5); FR (4); DE (11); PL (5); US (7)