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A Study to Demonstrate the Benefit of a New Kind of Anti-cancer Treatment [PReferentially Expressed Antigen of MElanoma (PRAME) Immunotherapy] for Patients With Non-Small Cell Lung Cancer (NSCLC), After Removal of Their Tumor (PEARL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01853878
First received: April 18, 2013
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer. The study will evaluate whether the PRAME immunotherapy lowers the risks of tumor recurrence after surgery.


Condition Intervention Phase
Lung Cancer, Non-Small Cell
Biological: Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Disease Free Survival (DFS) [ Time Frame: Approximately 60 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Approximately 60 months after randomization ] [ Designated as safety issue: No ]
  • Lung-cancer-specific survival [ Time Frame: Approximately 60 months after randomization ] [ Designated as safety issue: No ]
  • Disease Free Survival (DFS) at 2, 3, 4 and 5 years after randomization [ Time Frame: Approximately 60 months after randomization ] [ Designated as safety issue: No ]
  • Disease-free specific survival (DFSS) [ Time Frame: Approximately 60 months after randomization ] [ Designated as safety issue: No ]
  • anti-PRAME antibody concentrations at protocol defined timepoints [ Time Frame: Approximately 60 months after randomization ] [ Designated as safety issue: No ]
  • Occurrence of Adverse Events [ Time Frame: Up to 30 days post last dose of study product administration ] [ Designated as safety issue: No ]
  • Occurrence of abnormal hematological parameters [ Time Frame: Up to 30 days post last dose of study product administration ] [ Designated as safety issue: No ]
  • Occurrence of abnormal biochemical parameters [ Time Frame: Up to 30 days post last dose of study product administration ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: During the whole study duration OR up to 30 days after the last study product administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: June 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRAME ASCI group
Subjects will receive 13 doses of GSK2302032A Antigen-Specific Cancer Immunotherapeutic.
Biological: Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A
Intramuscular administration
Placebo Comparator: Placebo group
Subjects will receive 13 doses of placebo.
Biological: Placebo
Intramuscular administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has radically resected NSCLC.
  • The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC. The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy. The patient's tumor shows expression of PRAME.
  • The patient is ≥ 18 years of age at the time of first consent.
  • Written informed consent has been obtained from the patient prior to performance of any study-specific procedure.
  • The patient is free of disease (no residual tumor, no loco-regional recurrence, no distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be performed as clinically indicated.
  • Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 at the time of randomization.
  • Adequate bone-marrow reserve, adequate renal, hepatic and adrenal function as assessed by standard laboratory criteria.
  • If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausalor if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study product, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after last treatment administration.
  • Patients who the investigator believes can and will comply with the requirements of this protocol (e.g. return for active follow-up visits).

Exclusion Criteria:

  • The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years. Patients with effectively treated non - melanoma skin cancers or effectively treated carcinoma in situ of the cervix both of which in remission for less than 5 years will be eligible.
  • The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, except for:

    • Administration of adjuvant platinum-based doublet chemotherapy for the treatment of the current NSCLC allowed between surgery and randomization.
    • Treatment of previous malignancies as allowed by the protocol.
  • The patient has been diagnosed with a Potential Immune-Mediated Disease (pIMD). Patients with vitiligo are not excluded from the study.
  • The patient has a history of confirmed adrenal dysfunction.
  • The patient requires concomitant treatment with any immunosuppressive agent, or with systemic corticosteroids prescribed for chronic treatment (more than 7 consecutive days).
  • The patient needs chronic long term oxygen therapy (LTOT). The patient has medically uncontrolled congestive heart failure or hypertension, unstable heart disease or uncontrolled arrhythmia at the time of randomization.
  • The patient has an uncontrolled bleeding disorder.
  • The patient has undergone splenectomy.
  • The patient is known to be Human Immunodeficiency Virus (HIV)-positive.
  • 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.
  • The patient has a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
  • The patient has received any investigational or non-registered product within the 30 days preceding randomization, or planned use during the study period.
  • For female patients: the patient is pregnant or lactating or is planning to become pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853878

  Show 41 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01853878     History of Changes
Other Study ID Numbers: 116389, 2012-002790-55
Study First Received: April 18, 2013
Last Updated: October 23, 2014
Health Authority: Estonia: State Agency of Medicines
France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Korea: Korea Food and Drug Administration (KFDA)
Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Urząd Rejestracji Produktów Leczniczych, Wyrobób Medycznych i Produktów Biobójczych

Keywords provided by GlaxoSmithKline:
Immunotherapy
Antigen-Specific
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014