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

NCT ID: NCT01731587

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer (NSCLC) Stage III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

L-BLP25 plus Cyclophosphamide (CPA)

Group Type: EXPERIMENTAL

Biological: MUC1 peptide specific immunotherapy

Intervention Type: OTHER

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.

Cyclophosphamide (CPA)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

EMD531444; Stimuvax®; L01AA01; Endoxana

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

References

Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

Reference Type: DERIVED

PMID: 40443562 (View on PubMed)

Other Identifiers

2012-001435-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EMR 63325-019

Identifier Type: -

Identifier Source: org_study_id