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Colon CarcinomaPhase 2LICCNCT01462513

L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases

A Phase 2 study testing L-BLP25 in people with Colon Carcinoma and Rectum Carcinoma, run by Prof. Dr. Carl Schimanski at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and saline infusion). Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Colon Carcinoma, Rectum Carcinoma
What is being tested?
L-BLP25
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
21 sitesin 2 countries
Study dates
Aug 2011to 31 Jan 2018
Phase
Phase 2
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent.
  • Female patients of childbearing potential (and if appropriate male patients with female partners of childbearing potential) must be willing to use an adequate method of contraception for 4 weeks prior to, during and 12 weeks after the last dose of trial medication. A negative pregnancy test is required for female subjects. Adequate contraception for female subjects is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device or use of hormonal female contraceptive.
  • Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with complete resection of primary tumor and no evidence of local relapse.
  • Metastatic disease of the liver, with recent (< 8 weeks prior to randomization), both primary or secondary resection (R0 or R1) of all liver metastases. Metastasectomy may have been either synchronous or metachronous. Neoadjuvant therapy may have been applied prior to metastasectomy.
  • Subject has had a colonoscopy or rectoscopy within the last three months prior to initiation of therapy
  • Subject has an ECOG performance status of 0 or 1.
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  • Subject has adequate hematologic, hepatic, and renal function within 2 weeks prior to initiation of therapy as defined by the following: Absolute neutrophils > 1,500/mm3 and platelets > 140,000/mm3. Bilirubin < 1.5 x upper limit of normal (ULN). AST and ALT < 2.5 x ULN. Creatinine < 1.5 x ULN.
  • International Normalized Ratio (INR) and partial thromboplastin time (PTT) within normal range respectively within therapeutic range in case of anticoagulation.
  • Willingness to comply with study protocol requirements.

Who cannot join

  • Metastases other than liver metastases.
  • R2 and Rx resected liver metastases. Patients with R1 resected liver metastases can be included if a further surgical resection is seen as not indicated or necessary in the surgeon´s opinion.
  • Chemotherapy within 4 weeks prior to randomization.
  • Receipt of immunotherapy (e.g. interferons, tumor necrosis factor, interleukins, or growth factors [GM-CSF, G-CSF, M- CSF], monoclonal antibodies) within 4 weeks (28 days) prior to randomization.
  • Any known autoimmune disease, past or current.
  • A recognized immunodeficiency disease including cellular immuno-deficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies.
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  • Known or newly diagnosed active hepatitis B infection and/or hepatitis C infection, autoimmune hepatitis, known human immunodeficiency virus infection, or any other infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response, or expose him/ her to likelihood of more and/or severe side effects.
  • Past or current history of malignant neoplasm other than CRC, except for curatively treated non-melanoma skin cancer, in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
  • Medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements.
  • Clinically significant cardiac disease, e.g. cardiac failure of New York Heart Association classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, myocardial infarction in the previous 12 months as confirmed by an ECG.
  • Splenectomy.
  • Previous (less than 4 weeks prior to randomization) or concurrent treatment with a non-permitted drug.
  • Pregnancy and lactation period.
  • Participation in another clinical study within 30 days prior to randomization.
  • Known hypersensitivity to the study treatment drugs.
  • Known alcohol or drug abuse.
  • Legal incapacity or limited legal capacity.
  • Any other reason that, in the opinion of the investigator, precludes the subject from participating in this study.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

Germany20 sites

  • Klinikum Altenburger Land

    Altenburg, 04600

  • Campus Virchow-Klinikum, Charite Centrum 8

    Berlin, 13353

  • Klinikum Darmstadt

    Darmstadt, 64283

  • Universitätsklinikum Essen WTZ-Ambulanz, Innere Medizin (Tumorforschung)

    Essen, 45122

  • Klinik für Allgemeine Innere Medizin, Onkologie / Hämatologie

    Esslingen am Neckar, 73730

  • Klinikum der Johann W- Goethe Unversität, Klinik für Allgemein- und Viszeralchirurgie

    Frankfurt, 60590

  • Onkologische Schwerpunktpraxis Eppendorf

    Hamburg, 20249

  • Städtisches Klinikium Abt. Allgemein- und Visceralchirurgie

    Karlsruhe, 76133

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Universitätsmedizin Mainz

    Mainz, 55131

  • Universtitäsmedizin Gießen und Marburg

    Marburg, 35033

  • Praxis für Hämatologie und Onkologie

    Mülheim, 45468

  • Klinikum der Universität München-Grosshadern, Medizinische Klinik III

    München, 81377

  • GP für Hämatologie und Onkologie Offenburg

    Offenburg, 77654

  • Oncologianova GmbH

    Recklinghausen, 45657

  • Universitätsklinikum Regensburg

    Regensburg, 93042

  • Robert-Bosch Krankenhaus, Zentrum für Innere Medizin

    Stuttgart, 70376

  • Krankenhaus der Barmherzigen Brüder

    Trier, 54292

  • Klinikum Weiden, Medizinische Klinik I

    Weiden, 92637

Other trials in Germany

Austria1 site

  • Salzburger Universitätsklinikum, Universitätsklinik für Innere Medizin III

    Salzburg, 5020

Other trials in Austria

About this study

Official title: LICC: L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases - a Randomized, Placebo-controlled, Multicenter, Multinational, Double Blinded Phase II Trial

Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and saline infusion).

Read the detailed description

This trial is designed for patients with metastatic colorectal carcinoma (CRC), who have undergone a complete resection of their primary tumor and recent resection of their liver metastases (R0 or R1) with curative intent. No generally accepted standard care is available following curative-intent resection of hepatic metastases in colorectal cancer patients. L-BLP25 is a cancer vaccine that targets MUC1, a well known tumor-associated antigen. Recently, it has been shown that MUC1 is associated with cellular transformation as demonstrated by tumorigenicity and can confer resistance to genotoxic agents. High levels of MUC1 cell surface expression, reported immunosuppressive activities of its released ectodomain, and anti-adhesive properties all contribute to the ability of the MUC1 antigen to protect and promote tumor cell growth and survival, and make MUC1 an attractive target for cancer immunotherapy.

Based on these results, L BLP25 may have potential as adjuvant therapy after curative resection of hepatic metastases in colorectal cancer patients.

Being tested
L-BLP25, Placebo
Keywords
Colon carcinoma, Rectum carcinoma, Liver metastases
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • L-BLP25Biological

    Also called MUC1-antibody

    Treatment: 930µg per treatment once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.

  • PlaceboBiological

    Treatment: Placebo 930µg per treatment, once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.

Study groups in NCT01462513
Study groupRoleWhat they receive
L-BLP25ExperimentalL-BLP25 treatment
Receives: Biological: L-BLP25
PlaceboPlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

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

  1. Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and saline infusion).

    The primary variable of this trial is recurrence free survival (RFS) time. RFS time will be measured from the date of randomization to the date of recurrence. For subjects not known to have experienced recurrence or death at the time of analysis, the time between the date of randomization and the date of last evaluation for recurrence will be calculated and used as a censored observation in the analysis.

    Measured: until December 2017

Secondary outcomes (3)

  1. Safety / Tolerability

    Assessment of safety will include:

    • AEs, SAEs
    • Vital signs (body temperature, respiratory rate, heart rate, and blood pressure) and physical examinations,
    • Clinical laboratory assessments from hematology and biochemistry samples

    Measured: until December 2017

  2. Recurrence-free survival time in the subgroup of MUC1 positive cancers

    Recurrence free survival (RFS) time of MUC1 positive cancers will be measured from the date of randomization to the date of relapse based on standard imaging. For subjects not known to have experienced recurrence or death at the time of analysis, the time between the date of randomization and the date of last evaluation for recurrence or death will be calculated and used as a censored observation in the analysis.

    Measured: until December 2017

  3. Overall survival time in a subgroup of MUC1 positive cancers

    Overall survival time of MUC1 positive cancers will be measured from the date of randomization to the date of death. For subjects not known to be deceased at the time of analysis, the time between the date of randomization and the date of last contact, or date lost to follow-up, will be calculated and used as a censored observation in the analysis.

    Measured: until December 2017

Timeline

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

  1. First posted31 Oct 2011 (estimated)
  2. Study startAug 2011
  3. Primary completion31 Dec 2017
  4. Study completion31 Jan 2018

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462513
Sponsor's protocol ID
LICC01
Acronym
LICC
Status last verified
Feb 2018
First submitted
27 Oct 2011
Last updated
13 Feb 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Schimanski CC, Kasper S, Hegewisch-Becker S, Schroder J, Overkamp F, Kullmann F, Bechstein WO, Vohringer M, Ollinger R, Lordick F, Heinemann V, Geissler M, Schulz-Abelius A, Bernhard H, Schon MR, Greil R, Galle P, Lang H, Schmidtmann I, Moehler M. Adjuvant MUC vaccination with tecemotide after resection of colorectal liver metastases: a randomized, double-blind, placebo-controlled, multicenter AIO phase II trial (LICC). Oncoimmunology. 2020 Aug 23;9(1):1806680. doi: 10.1080/2162402X.2020.1806680.

    PubMed 32923171

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L-BLP25 in people with Colon Carcinoma and Rectum Carcinoma, run by Prof. Dr. Carl Schimanski at 21 sites in 2 countries.

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 9 inclusion and 18 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: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and saline infusion). (time frame: until December 2017). 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 NCT01462513, 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 13 Feb 2018.

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