Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma

NCT01208194 | Completed Phase 2 DMC

• 2 other identifiers: MGN1703-C022009-017432-40
• Study Type: interventional
• Target: 59
• Locations: 6 countries
• Sites: 12

Brief Summary

This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.

Conditions

Advanced Colorectal Carcinoma

Keywords

Advanced colorectal carcinoma; Maintenance therapy; Immunomodulator

Outcome Measures

Primary Outcomes (1)

• Evaluation of median progression-free survival (PFS) in both treatment groups

  Measured on accrual time 3 years

Secondary Outcomes (9)

• Assessment of PFS rate

  Measured at landmarks 12, 18 and 24 weeks after treatment start, and afterwards every 6 weeks until treatment stop

• Evaluation of median overall survival (OS)

  Measured on accrual time 3 years

• Assessment of OS proportion in both groups

  Measured at landmarks 12, 18 and 24 weeks after treatment start, and afterwards every 6 weeks until treatment stop

• Evaluation of overall response rate (ORR)

  Measured on accrual time 3 years

• Evaluation of duration of response (complete response, partial response, stable disease) as time from initial determination of response to progressive disease measured by RECIST

  Measured on accrual time 3 years

Study Arms (2)

MGN1703

EXPERIMENTAL

Study medication

Drug: MGN1703

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MGN1703 DRUG

solution, 60 mg, twice a week, until progression

Also known as: immunomodulator

MGN1703

Placebo DRUG

solution, 60 mg, twice a week, until progression

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female subjects older than 18 years of age
• Histologically confirmed colorectal carcinoma
• Radiological confirmation of unresectable advanced colorectal carcinoma (AJCC Stage IV) prior to start of initial first-line therapy
• At least one measurable lesion according to RECIST measured within 2 weeks prior to treatment start in case of partial response or stable disease
• Prior initial first-line therapy included oral or intravenous fluoropyrimidines/leucovorin,irinotecan or oxaliplatin with or without a standard dose of bevacizumab lasted between 4.5 and 6 months and finished (last day of last cycle) within 2 weeks prior to treatment start (treatment duration with irinotecan or oxaliplatin should not be less than 3 months)
• Patients who achieved disease control measured as objective response or disease stabilization after initial first-line therapy
• No curative standard therapy is available for the patient after first-line treatment
• ECOG performance status 0-1
• Adequate organ function, hemoglobin ≥ 9 g/L, white blood cell count (WBC) ≥ 3.0 x 109/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets \> 100 x109/L, aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN, bilirubin \< 1.5 x ULN, blood creatinine ≤ 1.5 X ULN, prothrombin time (PT) and activated thromboplastin time (aPTT) within normal range
• Negative pregnancy test in women with childbearing potential
• Expected adequacy of follow-up
• Signed informed consent form (ICF)

You may not qualify if:

• More than one line of systemic chemotherapy for metastatic colorectal carcinoma
• Tumor progression after initial first-line therapy
• Clinically significant concomitant diseases or conditions, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
• Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
• Known central nervous system metastases
• Active or uncontrolled infections
• Transfusion-dependent anemia
• History of autoimmune disease or immune deficiency
• Known hypersensitivity to oligonucleotides or excipients of the formulation
• Pregnancy and/or nursing
• Concurrent chronic systemic immune therapy or immunosuppressant medication, including steroid treatment
• Concurrent chemotherapy, hormonal therapy (except hormonal contraception and hormonal replacement therapy for menopausal women), or immunotherapy within the last 2 weeks prior to randomization or during the conduct of the study - Concurrent radiotherapy within the last 6 months prior to randomization or during the conduct of the study
• Known HIV seropositivity or active hepatitis B or C infection
• Planned major surgery during the study
• Participation in another clinical study with other investigational drugs within 30 days prior to the first treatment day

Sponsors & Collaborators

• Mologen AG: lead

Study Sites (12)

Klinik für Innere Medizin I, Abteilung für Klinische Onkologie, Medizinische Universität Wien

Vienna, 1090, Austria

Location

Oncology Clinic, Faculty Hospital Olomouc

Olomouc, 77520, Czechia

Location

Service de Cancérologie Digestive, Institut de Cancérologie Gustave Roussy

Villejuif, 94805, France

Location

Onkologischer Schwerpunkt am Oskar-Helene-Heim

Berlin, 14195, Germany

Location

Klinik für Innere Medizin IV, Onkologie/ Hämatologie/ Hämostaseologie, Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Kath. Marienkrankenhaus GmbH, Allgemeine Onkologie

Hamburg, 22087, Germany

Location

Schwerpunktpraxis für Hämatologie und Onkologie

Magdeburg, 39104, Germany

Location

Klinik für Innere Medizin, Klinik für Hämatologie, Onkologie, Immunologie, Universitätsklinikum Giessen und Marburg GmbH

Marburg, 35043, Germany

Location

Medizinische Klinik, Abteilung für Onkologie, Hämatologie Immunologie, Rheumatologie und Pulmologie Universität Tübingen, Immuntherapie, Station 65 Med. Klinik Abt. II

Tübingen, 72076, Germany

Location

State Institution "Russian Scientific Oncology Center named after N.N. Blokhin RAMN"

Moscow, 115478, Russia

Location

Non-state health care institution "Central Clinical Hospital No. 2 named after N.A. Semashko OAO "RZHD"

Moscow, 129128, Russia

Location

Mount Vernon Cancer Centre

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

MeSH Terms

Interventions

MGN1703; Immunologic Factors

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Hans-Joachim Schmoll

  Klinik für Innere Medizin IV, Universitätsklinikum Halle (Saale)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: September 23, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

RU (2); CZ (1); DE (6); GB (1); FR (1); AU (1)