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

NCT01731587 | Withdrawn Phase 1

• 2 other identifiers: EMR 63325-0192012-001435-31
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Non-small cell lung cancer (NSCLC); exploratory study; L-BLP25

Outcome Measures

Primary Outcomes (1)

• Immune response defined as change from baseline in serum cytokine levels after L-BLP25 administration at Week 1, 4 and 8

  Pre-dose (Day -3) up to 24 hours after L-BLP25 administration at Week 1, 4 and 8

Secondary Outcomes (3)

• Evaluation of a cellular immune response following treatment with L-BLP25

  Pre-dose (Day -3) and at 24 hours after L-BLP25 administration at Week 4 and 8

• 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.

  Pre-dose (Day -3) up to 24 hours after L-BLP25 administration at Week 1, 4 and 8

• Number of subjects with adverse events (AEs)

  Up to 6 weeks after the last dose of L-BLP25

Study Arms (1)

L-BLP25 plus Cyclophosphamide (CPA)

EXPERIMENTAL

Other: Biological: MUC1 peptide specific immunotherapy; Drug: Cyclophosphamide (CPA)

Interventions

Biological: MUC1 peptide specific immunotherapy 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.

Also known as: EMD531444, Stimuvax®

L-BLP25 plus Cyclophosphamide (CPA)

Cyclophosphamide (CPA) 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.

Also known as: L01AA01, Endoxana

L-BLP25 plus Cyclophosphamide (CPA)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Related Publications (1)

• 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.

  PMID: 40443562 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

L-BLP25; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Study Director

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: November 22, 2012
• Study Start: January 1, 2001
• Last Updated: February 28, 2017

Record last verified: 2017-02