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Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment (IMPALA)

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ClinicalTrials.gov Identifier: NCT02077868
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mologen AG

Brief Summary:
The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Other: Usual Maintenance Drug: MGN1703 treatment Phase 3

Detailed Description:

Due to the toxicity of chemotherapeutic medications treatment breaks are common practice in the treatment of metastatic colorectal cancer. During these treatment breaks a variety of maintenance treatments are available.

MGN1703 is developed not only to help the Patient to recover from chemotherapy but also to boost the patient's immune System and thus help him to effectively fight the Tumor himself.

After the concept has already been proved in a previous study this Trial is conducted to further evaluate the safety and efficacy of MGN1703 Treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment
Actual Study Start Date : September 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control Arm A
Patients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision
Other: Usual Maintenance
Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other

Experimental: Treatment Arm B
MGN1703 treatment as maintenance therapy
Drug: MGN1703 treatment
MGN1703 will be used as single agent maintenance treatment
Other Name: dSLIM




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
    Overall survival after randomization


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 36 months ]
    PFS1: from randomization until first PD PFS2: from start of re-introduction therapy until second PD PFS3: from start of first-line Treatment until second PD

  2. Safety [ Time Frame: 36 months ]
    AEs, vital signs, ECGs, safety labs as required

  3. Overall Response rate [ Time Frame: 36 months ]
    Complete and partial responses according RECIST 1.1 after randomization

  4. Quality of life (QoL) [ Time Frame: 36 months ]
    QoL according EORTC questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Male or female patient 18 years or older
  • Histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present)
  • Complete or partial response, as assessed by local investigators according to RECIST 1.1, within 12-30 weeks from start of induction treatment with standard first-line chemotherapy with or without biological agents
  • ECOG PS 0-1
  • Haematology and biochemistry laboratory results within the limits normally expected for the patient population recovering after receiving induction treatment
  • Male and female patients of childbearing potential (i.e. did not undergo surgical sterilization - hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and are not post-menopausal for at least 24 consecutive months) must use an effective method of contraception. Females of child bearing potential must have a negative serum pregnancy test

Exclusion Criteria:

  • History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
  • Known brain metastases (present or treated)
  • Contraindication to receiving MGN1703 as per current investigator brochure
  • Known hypersensitivity to any component of the study product
  • Prior allogeneic stem cell transplantation or organ transplantation
  • Active or uncontrolled infections or undiagnosed febrile condition
  • Severe anemia requiring repeated blood cell transfusion
  • Pre-existing autoimmune or antibody-mediated diseases or immune deficiency
  • Chronic systemic immune therapy or immunosuppressant medication other than steroids within the last 6 weeks; continuous systemic steroid treatment within the last 2 weeks prior to start of study treatment
  • Use of systemic antibiotic therapy within the last 2 weeks prior to start of study treatment
  • Inadequate pulmonary function according to the Investigator's judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  • HIV seropositivity or active HBV/HCV infection
  • Serious concomitant disease or medical condition that in the judgment of the investigator renders the patient at high risk of treatment complications
  • Female patient who is pregnant or breast feeding
  • Contraindication to receive the planned standard maintenance treatment according to applicable SmPC
  • Treatment with any anti-cancer investigational drug within 12 months prior to study treatment or participation in another clinical study with other investigational drugs within 28 days prior to study treatment
  • Vaccination within 1 months prior to start of study treatment
  • Any medical, mental, psychological or psychiatric condition that in the opinion of the investigator would not permit the patient to complete the study or understand the patient information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077868


  Show 127 Study Locations
Sponsors and Collaborators
Mologen AG
Investigators
Principal Investigator: David Cunningham, MD Royal Marsden Hospital, London

Additional Information:
Responsible Party: Mologen AG
ClinicalTrials.gov Identifier: NCT02077868     History of Changes
Other Study ID Numbers: MGN1703-C06
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Mologen AG:
CRC
mCRC
maintenance treatment
immune modulation
colorectal cancer
immunotherapy
metastatic

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases