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

Mologen

Status and phase

Completed

Phase 2

Conditions

Advanced Colorectal Carcinoma

Treatments

Drug: MGN1703

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01208194

MGN1703-C02

2009-017432-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The phase 2 study will be conducted in patients with advanced colorectal carcinoma with disease control after first-line standard chemotherapy regimens with oral or intravenous fluoropyrimidines/leucovorin and irinotecan or oxaliplatin combined with a standard dose of bevacizumab lasted between 4.5 and 6 months, whereas the treatment duration with irinotecan or oxaliplatin should not be less than 3 months. Studies confirmed that completely chemotherapy-free intervals can be applicable in patients with advanced colorectal carcinoma who achieved disease control after initial first-line chemotherapy. Those therapy holidays minimize toxicity and unnecessary treatment load, reduce intensity of treatment, allow patients to stay longer on therapy, prevent therapy discontinuations due to toxicity, preserve the ability to re-administer chemotherapy later, and increase quality of life of the patients. The therapy-free interval represents a possibility to evaluate the efficacy of the study drug, MGN1703.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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
Vaccination within 3 months prior to the first treatment day
Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
Presence of drug and/or alcohol abuse