AzTrials
AzTrials

Non-small Cell Lung Cancer (NSCLC) Stage IIIPhase 1FINGERPRINTNCT01731587

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

A Phase 1 study testing Biological: MUC1 peptide specific immunotherapy and Cyclophosphamide (CPA) in people with Non-small Cell Lung Cancer (NSCLC) Stage III, run by Merck KGaA, Darmstadt, Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biological: MUC1 peptide specific immunotherapy and Cyclophosphamide (CPA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2001to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

About this study

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

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.

Being tested
Biological: MUC1 peptide specific immunotherapy, Cyclophosphamide (CPA)
Keywords
Non-small cell lung cancer (NSCLC), exploratory study, L-BLP25
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological: MUC1 peptide specific immunotherapyOther

    Also called EMD531444, Stimuvax®

    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)Drug

    Also called L01AA01, Endoxana

    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.

Study groups in NCT01731587
Study groupRoleWhat they receive
L-BLP25 plus Cyclophosphamide (CPA)ExperimentalNot described
Receives: Other: Biological: MUC1 peptide specific immunotherapy; Drug: Cyclophosphamide (CPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (3)

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

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

  2. 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.

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

  3. Number of subjects with adverse events (AEs)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2012 (estimated)
  2. Study startJan 2001

Why it stopped: The objectives of this trial are no longer deemed appropriate for the clinical development of L-BLP25 therefore this trial is withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01731587
Sponsor's protocol ID
EMR 63325-019
Other IDs
2012-001435-31
Acronym
FINGERPRINT
Status last verified
Feb 2017
First submitted
11 Oct 2012
Last updated
28 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40443562

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biological: MUC1 peptide specific immunotherapy and Cyclophosphamide (CPA) in people with Non-small Cell Lung Cancer (NSCLC) Stage III, run by Merck KGaA, Darmstadt, Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01731587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in