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Anti-cancer MUC1-specific Immunotherapy for Unresectable Stage III Non-small Cell Lung Cancer (FINGERPRINT)

This study has been withdrawn prior to enrollment.
(The objectives of this trial are no longer deemed appropriate for the clinical development of L-BLP25 therefore this trial is withdrawn)
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01731587
First received: October 11, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

Phase Ib study investigating whether liposome BLP25 mucin-1 (MUC1) peptide-specific immunotherapy (L-BLP25) administered as weekly subcutaneous doses over 8 weeks following a single dose of intravenous cyclophosphamide (CPA) induces a reproducible cytokine pattern measured in the serum of unresected Stage III non-small cell lung cancer (NSCLC) subjects after first-line chemo-radiation therapy.


Condition Intervention Phase
Non-small Cell Lung Cancer (NSCLC) Stage III
Other: Biological: MUC1 peptide specific immunotherapy
Drug: Cyclophosphamide (CPA)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase Ib, Single-arm, Proof-of-principle Trial Investigating the Cytokine Profile and Specific T Cell Response in Peripheral Blood of Non-small Cell Lung Cancer (NSCLC) Subjects With Unresected Stage III Disease Treated With L-BLP25

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Immune response defined as change from baseline in serum cytokine levels after L-BLP25 administration at Week 1, 4 and 8 [ Time Frame: Pre-dose (Day -3) up to 24 hours after L-BLP25 administration at Week 1, 4 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of a cellular immune response following treatment with L-BLP25 [ Time Frame: Pre-dose (Day -3) and at 24 hours after L-BLP25 administration at Week 4 and 8 ] [ Designated as safety issue: No ]
  • Change from baseline in alternative immune or inflammatory serum soluble immune mediators such as interferon alpha (IFNα), transforming growth factor beta (TGFβ), or C-reactive protein (CRP) at 6, 12, and 24 hours after L-BLP25 administration. [ Time Frame: Pre-dose (Day -3) up to 24 hours after L-BLP25 administration at Week 1, 4 and 8 ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events (AEs) [ Time Frame: Up to 6 weeks after the last dose of L-BLP25 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
Experimental: L-BLP25 plus Cyclophosphamide (CPA) Other: Biological: MUC1 peptide specific immunotherapy
Eight consecutive weekly subcutaneous administration with reconstituted L-BLP25 (containing 806 microgram of BLP25 lipopeptide) followed by administrations at 6-week intervals, commencing at Week 14, until disease progression is documented.
Other Names:
  • EMD531444
  • Stimuvax®
Drug: Cyclophosphamide (CPA)
A single intravenous infusion of 300 milligram per square meter (to a maximum of 600 milligram) of CPA will be given three days before the first L-BLP25 administration.
Other Names:
  • L01AA01
  • Endoxana

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically documented unresectable Stage III NSCLC, as defined by American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 7th edition (2009) criteria. All histological subtypes are acceptable, including bronchioalveolar carcinomas
  • Documented stable disease or objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0, after primary chemo-radiotherapy (either sequential or concomitant) for unresected Stage III disease, within 4 weeks (28 days) prior to enrollment
  • Receipt of concomitant or sequential chemo-radiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of greater than equal to 50 Gray. Subjects must have completed the primary thoracic chemo-radiotherapy at least 4 weeks (28 days) and no later than 84 days prior to enrollment. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible
  • Platelet count greater than or equal to 140 * 10^9 per liter, white blood cell (WBC) greater than or equal to 2.5 * 10^9 per liter, and hemoglobin greater than or equal to 90 gram per liter
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1

Additional Inclusion Criteria apply

Exclusion Criteria:

  • Pre-therapies:

    • Previous lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy
    • Receipt of immunotherapy within 4 weeks (28 days) prior to enrollment. Note: Subjects who have received monoclonal antibodies for imaging are acceptable
    • Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to enrollment
  • Disease status:

    • Metastatic disease
    • Malignant pleural effusion at initial diagnosis and/or at trial entry
    • Past or current history of neoplasm other than lung carcinoma, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
    • Autoimmune disease
    • A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
    • Any preexisting medical condition requiring systemic chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
    • Known Hepatitis B and/or C
    • Active infection at enrollment, including but not limited to, flu-like infections, urinary tract infections, bronchopulmonary infections, etc
  • Physiological functions:

    • Clinically significant hepatic dysfunction (that is, alanine aminotransferase [ALT] greater than 2.5 times normal upper limit [ULN]; or aspartate aminotransferase [AST] greater than 2.5 times ULN; or bilirubin greater than or equal to 1.5 * ULN)
    • Clinically significant renal dysfunction (that is, serum creatinine greater than or equal to 1.5 * ULN)
    • Clinically significant cardiac disease, for example, New York Heart Association (NYHA) Classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG)
    • Splenectomy
    • Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response

Additional Exclusion Criteria apply

  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: NCT01731587

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Study Director Merck KGaA
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01731587     History of Changes
Other Study ID Numbers: EMR 63325-019, 2012-001435-31
Study First Received: October 11, 2012
Last Updated: February 3, 2014
Health Authority: Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Poland: Ethics Committee
Poland: Ministry of Health

Keywords provided by Merck KGaA:
Non-small cell lung cancer (NSCLC)
exploratory study
L-BLP25

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
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014