Advanced Colorectal CarcinomaPhase 2IMPACTNCT01208194
Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma
A Phase 2 study testing MGN1703 in people with Advanced Colorectal Carcinoma, run by Mologen AG at 12 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma
- What is being tested?
- MGN1703
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 12 sitesin 6 countries
- Study dates
- Jun 2010to Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Germany6 sites
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, 14195
Klinik für Innere Medizin IV, Onkologie/ Hämatologie/ Hämostaseologie, Universitätsklinikum Halle (Saale)
Halle, 06120
Kath. Marienkrankenhaus GmbH, Allgemeine Onkologie
Hamburg, 22087
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, 39104
Klinik für Innere Medizin, Klinik für Hämatologie, Onkologie, Immunologie, Universitätsklinikum Giessen und Marburg GmbH
Marburg, 35043
Medizinische Klinik, Abteilung für Onkologie, Hämatologie Immunologie, Rheumatologie und Pulmologie Universität Tübingen, Immuntherapie, Station 65 Med. Klinik Abt. II
Tübingen, 72076
Russia2 sites
State Institution "Russian Scientific Oncology Center named after N.N. Blokhin RAMN"
Moscow, 115478
Non-state health care institution "Central Clinical Hospital No. 2 named after N.A. Semashko OAO "RZHD"
Moscow, 129128
Austria1 site
Klinik für Innere Medizin I, Abteilung für Klinische Onkologie, Medizinische Universität Wien
Vienna, 1090
France1 site
Service de Cancérologie Digestive, Institut de Cancérologie Gustave Roussy
Villejuif, 94805
United Kingdom1 site
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN
About this study
Official title: Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma With Disease Control After Initial First-line Therapy
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.
Read the detailed 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.
- Conditions
- Advanced Colorectal Carcinoma
- Being tested
- MGN1703, Placebo
- Keywords
- Advanced colorectal carcinoma, Maintenance therapy, Immunomodulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGN1703Drug
Also called immunomodulator
solution, 60 mg, twice a week, until progression
PlaceboDrug
solution, 60 mg, twice a week, until progression
| Study group | Role | What they receive |
|---|---|---|
| MGN1703 | Experimental | Study medication Receives: Drug: MGN1703 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of median progression-free survival (PFS) in both treatment groups
Measured: Measured on accrual time 3 years
Secondary outcomes (9)
Assessment of PFS rate
Measured: 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: Measured on accrual time 3 years
Assessment of OS proportion in both groups
Measured: 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: 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: Measured on accrual time 3 years
Assessment of the dynamic of clinical and laboratory parameters
Measured: An average time: participants are followed until progress
Evaluation of immunologic response to MGN1703
Measured: An average time: participants are followed until progress
Assessment of quality of life (QOL)
Measured: An average time: participants are followed until progress
Assessment of the safety profile of MGN1703
Measured: An average time: participants are followed until progress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mologen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Joachim Schmoll, Principal investigator, Klinik für Innere Medizin IV, Universitätsklinikum Halle (Saale)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208194
- Sponsor's protocol ID
- MGN1703-C02
- Other IDs
- 2009-017432-40, 2009
- Acronym
- IMPACT
- Status last verified
- Jun 2014
- First submitted
- 27 Aug 2010
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma With Disease Control After Initial First-line Therapy
- ClinicalTrials.gov ID
- NCT01208194
- Acronym / sponsor ID
- IMPACT / MGN1703-C02
- Conditions
- Advanced Colorectal Carcinoma
- Keywords
- Advanced colorectal carcinoma, Maintenance therapy, Immunomodulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mologen AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGN1703 | Experimental | Drug: MGN1703Study medication |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGN1703Also: immunomodulatorsolution, 60 mg, twice a week, until progression | Drug | MGN1703 |
| Placebosolution, 60 mg, twice a week, until progression | Drug | Placebo |
Primary outcome
Evaluation of median progression-free survival (PFS) in both treatment groups
Time frame: Measured on accrual time 3 years
9 secondary outcomes
Assessment of PFS rate
Time frame: 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)
Time frame: Measured on accrual time 3 years
Assessment of OS proportion in both groups
Time frame: 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)
Time frame: 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
Time frame: Measured on accrual time 3 years
Assessment of the dynamic of clinical and laboratory parameters
Time frame: An average time: participants are followed until progress
Evaluation of immunologic response to MGN1703
Time frame: An average time: participants are followed until progress
Assessment of quality of life (QOL)
Time frame: An average time: participants are followed until progress
Assessment of the safety profile of MGN1703
Time frame: An average time: participants are followed until progress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Joachim Schmoll principal investigator
Klinik für Innere Medizin IV, Universitätsklinikum Halle (Saale)
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MGN1703 in people with Advanced Colorectal Carcinoma, run by Mologen AG at 12 sites in 6 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 12 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 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Russia, Austria, Czechia, France and 1 more country. 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?
Evaluation of median progression-free survival (PFS) in both treatment groups (time frame: Measured on accrual time 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2014.