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

NCT01462513 | Completed Phase 2 DMC

• 1 other identifier: LICC01
• Study Type: interventional
• Target: 122
• Locations: 2 countries
• Sites: 21

Brief 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).

Conditions

Colon Carcinoma; Rectum Carcinoma

Keywords

Colon carcinoma; Rectum carcinoma; Liver metastases

Outcome Measures

Primary Outcomes (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.

  until December 2017

Secondary Outcomes (3)

• Safety / Tolerability

  until December 2017

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

  until December 2017

• Overall survival time in a subgroup of MUC1 positive cancers

  until December 2017

Study Arms (2)

L-BLP25

EXPERIMENTAL

L-BLP25 treatment

Biological: L-BLP25

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

L-BLP25 BIOLOGICAL

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

Also known as: MUC1-antibody

L-BLP25

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Prof. Dr. Carl Schimanski: lead

Study Sites (21)

Salzburger Universitätsklinikum, Universitätsklinik für Innere Medizin III

Salzburg, 5020, Austria

Location

Klinikum Altenburger Land

Altenburg, 04600, Germany

Location

Campus Virchow-Klinikum, Charite Centrum 8

Berlin, 13353, Germany

Location

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

Universitätsklinikum Essen WTZ-Ambulanz, Innere Medizin (Tumorforschung)

Essen, 45122, Germany

Location

Klinik für Allgemeine Innere Medizin, Onkologie / Hämatologie

Esslingen am Neckar, 73730, Germany

Location

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

Frankfurt, 60590, Germany

Location

Onkologische Schwerpunktpraxis Eppendorf

Hamburg, 20249, Germany

Location

Städtisches Klinikium Abt. Allgemein- und Visceralchirurgie

Karlsruhe, 76133, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Universtitäsmedizin Gießen und Marburg

Marburg, 35033, Germany

Location

Praxis für Hämatologie und Onkologie

Mülheim, 45468, Germany

Location

Klinikum der Universität München-Grosshadern, Medizinische Klinik III

München, 81377, Germany

Location

GP für Hämatologie und Onkologie Offenburg

Offenburg, 77654, Germany

Location

Oncologianova GmbH

Recklinghausen, 45657, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93042, Germany

Location

Robert-Bosch Krankenhaus, Zentrum für Innere Medizin

Stuttgart, 70376, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Klinikum Weiden, Medizinische Klinik I

Weiden, 92637, Germany

Location

Related Publications (1)

• 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.

  PMID: 32923171 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

L-BLP25; MUC-1 monoclonal antibody

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Carl Christoph Schimanski, Prof. Dr.

  Universitätsmedizin Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: October 31, 2011
• Study Start: August 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: January 31, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

AU (1); DE (20)