Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Glomerulonephritis, Membranous

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Membranous Nephropathy

Pharmaceutical Solutions

All Drugs and Chemicals

Immunomodulating Agents

Adjuvants, Immunologic

Immunologic Factors

solution, 60 mg, twice a week, until progression

MGN1703

Placebo

Hans-Joachim Schmoll

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.

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.

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

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

Mologen AG

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants receive MGN1703 on Days 1, 8, and 15 of all cycles as an injection under the skin. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration.

Each cycle is 21 days long. Participants receive a total of 4 treatment cycles for a total of 12 weeks on treatment.

Dose expansion group consists of participants with advanced malignancy and cutaneous or subcutaneous manifestations.

MGN1703 given subcutaneously at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration.

Each cycle is 21 days long.

Dose expansion group consists of participants with advanced malignancy and cutaneous or or subcutaneous manifestations.

MGN1703 given by intratumoral injection at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration.

Each cycle is 21 days long.

Dose expansion group consists of participants with advanced malignancy treated with radiation (XRT) within the past 2 weeks.

MGN1703 given subcutaneously at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration.

Each cycle is 21 days long.

Dose Escalation Group Starting Dose: 15 mg on Days 1, 8, and 15 of each 21 day cycle.

Dose Expansion Group Starting Dose: Maximum tolerated dose from Dose Escalation Group.

Dose Escalation and Dose Expansion Group Dose: 3 mg/kg by vein on Day 8 of a 21 day cycle.

David S. Hong, MD

The goal of this clinical research study is to find the highest tolerable dose of MGN1703 that can be given in combination with ipilimumab to patients with advanced tumors. The safety of this drug combination will also be studied.

This is an investigational study. MGN1703 is not FDA approved or commercially available. It is currently being used for research purposes only. Ipilimumab is FDA approved and commercially available for the treatment of unresectable (cannot be removed with surgery) or metastatic (has spread) melanoma.

Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of MGN1703 based on when you joined this study. Up to 4 dose levels of MGN1703 will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of MGN1703. Each new group will receive a higher dose of MGN1703 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of MGN1703 is found. This is called dose escalation.

In another part of the study (called dose expansion) up to 3 groups of up to 12 additional participants will be enrolled. Two (2) groups will receive MGN1703 at the highest tolerable dose that was found in dose escalation. One (1) group will receive the first dose level of MGN1703 (if it is found to be tolerable). The study doctor will tell you which dose of MGN1703 you will receive.

All participants will receive the same dose level of ipilimumab. You will receive ipilimumab at standard doses.

Study Drug Administration:

Each study cycle is 21 days.

You will be given MGN1703 as an injection under the skin on Days 1, 8, and 15 of each cycle. Each administration will be between 1-4 injections in multiple parts of your body (such as your upper arms and thighs, your abdomen and thighs, or your abdomen and upper arms). The study doctor will tell you how many times you will be injected.

If you are in dose expansion, you may receive MGN1703 as an injection directly into the tumor. The study doctor will tell you if you will receive the study drug this way.

You will also receive ipilimumab by vein over about 90 minutes on Day 8 of Cycles 1-4.

Study Visits:

During Week 1 of every cycle, blood (about 1 teaspoon) will be drawn for routine tests.

During Week 2 of Cycles 1-4, you will have a physical exam.

During Week 3 of Cycles 1 and 3, blood (about 5 teaspoons) will be drawn for routine tests and biomarker testing.

During Week 3 of Cycles 2 and 4:

* Blood (about 5 teaspoons) will be drawn for routine tests and biomarker testing.
* Urine will be collected for routine tests.
* You will have an EKG.
* You will have imaging scans to check the status of the disease.
* If you can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.

If you are in dose expansion and depending on when you join the study, on Day 1 of Cycle 3 you will have a biopsy for biomarker testing (including genetic biomarkers).

During Cycle 4 and then every even-numbered cycle after that (Cycles 6, 8, 10, and so on):

* You will have a physical exam.
* Blood (about 5 teaspoons) will be drawn for routine tests and biomarker testing.
* You will have imaging scans to check the status of the disease. After 1 year on study, you will have these scans every 4 cycles.

During Cycle 4 and then every 4 cycles after that (Cycles 8, 12, 16, and so on):

* Urine will be collected for routine tests.
* You will have an EKG.
* If you can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.

Every 30 days for 90 days after your last dose of study drug, you will be called by a member of the study staff and asked about any new anticancer drugs you may have started and how you are feeling. You may also be asked these questions during a routine clinic visit or this information may be collected from your medical record. If you are called, each call should last about 10-15 minutes.

Length of Study:

You may receive MGN1703 in combination with ipilimumab for up to 4 cycles. After that, you may continue taking MGN1703 alone for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

You participation on this study will be over 90 days after your last dose of study drug.

Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies

A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies

If more than or equal to one third of the participants at a dose level experience dose limiting toxicity (DLT), the MTD reassessed and the next lowest dose level for the combination therapy considered the MTD.

Tumor response defined as one or other of the following: (1) stable disease for more than than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by irRC criteria.

M.D. Anderson Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

MGN1703, solution in Dulbecco's Phosphate-Buffered Saline (DPBS), 2 mL of 60 mg/4 mL (15 mg/mL), administered SC at 2 application sites twice weekly

Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other

Standard of care

Veerle Surmont, MD

Georg Pall, MD

Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC) as maintenance treatment in patients with extensive disease small cell lung cancer (SCLC) who achieved at least a partial response (PR) following platinum-based first-line therapy.

Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

Randomized Clinical Study of Maintenance Therapy With Immunomodulator MGN1703 in Patients With Extensive Disease Small Cell Lung Cancer After Platinum-Based First-Line Therapy

Progression-free survival is the time after randomization to either disease progression (PD), measured using RECIST 1.1 and irRC criteria and confirmed via centralized review or death

The primary efficacy endpoint is the OS which is defined as the time interval starting with the randomization and lasting until death (=event) or until the date of last information available from the patient.

The secondary efficacy endpoint OS1 is defined as the time interval starting at the first cycle of induction therapy and lasting until death (=event) or until the date of last information available from the patient.

OS1 will be estimated by Kaplan-Meier estimates. The comparison between the treatment groups will be performed using the log-rank test with a significance level of α = 2.5% for the 1-sided test. The OS1 will be presented as Kaplan-Meier figures also.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma	NCT01208194	Advanced Colore...	MGN1703 Placebo	18 Years -	Mologen AG
Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies	NCT02668770	Advanced Cancer... Melanoma	MGN1703 Ipilimumab	18 Years -	M.D. Anderson Cancer Center
Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC	NCT02200081	Small Cell Lung...	MGN1703 Standard of car...	18 Years -	Mologen AG
Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies	NCT02668770	Advanced Cancer... Melanoma	MGN1703 Ipilimumab	18 Years -	M.D. Anderson Cancer Center
Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC	NCT02200081	Small Cell Lung...	MGN1703 Standard of car...	18 Years -	Mologen AG
Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies	NCT02668770	Advanced Cancer... Melanoma	MGN1703 Ipilimumab	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for mgn1703

Every month we try and update this database with for mgn1703 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mgn1703

Every month we try and update this database with for mgn1703 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mgn1703 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.