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Checkpoint Inhibitor
Immunotherapy with TLR Agonist for Cancer
Phase 1
Waitlist Available
Led By David S. Hong, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
ECOG performance status </= 2 (Karnofsky >60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights
Study Summary
This trial is testing a new combination cancer therapy to see if it is safe and effective.
Who is the study for?
Adults with advanced solid tumors that standard therapy has failed to cure or for which no standard treatment exists can join this trial. They must have been off other treatments for at least 4 weeks, have a stable health status, and agree to use contraception. People with severe allergies to the study drugs, recent vaccines, certain infections or diseases like severe autoimmune disorders cannot participate.Check my eligibility
What is being tested?
The trial is testing the highest dose of MGN1703 (not FDA approved) that's safe when given with ipilimumab (FDA approved for melanoma) in patients with advanced tumors. Researchers want to see how well these two drugs work together and what side effects they might cause.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells in various organs, allergic reactions specific to drug components, fatigue, digestive issues such as bowel inflammation or perforation, skin conditions like rash or itching, and potential hormonal imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread, and standard treatments haven't worked or aren't available.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 84 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of MGN1703 with Ipilimumab
Secondary outcome measures
Tumor Response
Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Trial Design
4Treatment groups
Experimental Treatment
Group I: MTD Post XRT Group: MGN1703 (subcutaneously) + IpilimumabExperimental Treatment2 Interventions
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.
Group II: MTD Group: MGN1703 (subcutaneously) + IpilimumabExperimental Treatment2 Interventions
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.
Group III: MTD Group: MGN1703 (intratumoral injection) + IpilimumabExperimental Treatment2 Interventions
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.
Group IV: Dose Escalation Group: MGN1703 + IpilimumabExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MGN1703
2014
Completed Phase 2
~180
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,753 Total Patients Enrolled
102 Trials studying Melanoma
25,307 Patients Enrolled for Melanoma
Mologen AGIndustry Sponsor
6 Previous Clinical Trials
746 Total Patients Enrolled
David S. Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
533 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation therapy in the last 4 weeks.I don't have any health issues that could make the study drug dangerous for me or affect the study results.I am HIV-positive on HAART or have Hepatitis B/C and am receiving treatment.You have a disease that can be measured using specific criteria.I have had serious gut issues like diverticulitis or blockages.I haven't had vaccines for infectious diseases a month before or after ipilimumab.You have a severe autoimmune disease like Crohn's disease or lupus. If you have a mild autoimmune disorder like psoriasis, the study doctor will decide if you can participate.I am not currently on treatments like IL-2, interferon, chemotherapy, or long-term steroids for non-cancer conditions.My cancer is advanced or has spread, and standard treatments haven't worked or aren't available.I haven't had chemotherapy, hormonal, or biological therapy for at least 4 weeks.I am not pregnant or breastfeeding and agree to use contraception during the study.I am not using any experimental cancer treatments, except for prostate cancer hormone therapy if applicable.I have been treated with TLR agonist therapy before.My blood and organ functions are within the required ranges for the trial.I am a woman able to have children and have a recent negative pregnancy test.I have recovered from previous treatment side effects, except for stable mild nerve pain.I haven't had major surgery or a serious injury in the last 28 days.I can take care of myself but might not be able to do heavy physical work.You have a history of adrenal failure based on blood test results for cortisol and ACTH levels.I am 18 years old or older.I do not have any severe infections, heart failure, liver cirrhosis, pancreatitis, or other uncontrolled diseases.I may have had any number of previous treatments.
Research Study Groups:
This trial has the following groups:- Group 1: MTD Post XRT Group: MGN1703 (subcutaneously) + Ipilimumab
- Group 2: Dose Escalation Group: MGN1703 + Ipilimumab
- Group 3: MTD Group: MGN1703 (subcutaneously) + Ipilimumab
- Group 4: MTD Group: MGN1703 (intratumoral injection) + Ipilimumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What kind of risks do people take when using MGN1703?
"There is limited knowledge of the safety and efficacy of MGN1703, thus it earned a score of 1."
Answered by AI
What are the traditional uses of MGN1703?
"MGN1703 is typically used to help patients with cutaneous melanoma, though it can also be prescribed for cases of complete resection and metastatic liver carcinoma."
Answered by AI
How many participants are included in the current research?
"This research is no longer recruiting test subjects. It was originally posted on May 11th 2016 and modified in February of 2022. However, if you are still looking to join a clinical trial for melanoma, there are currently 3124 active studies enrolling patients; the same goes for MGN1703 with 318 trials open."
Answered by AI
Are there any records of past experiments regarding the pharmacological effects of MGN1703?
"Presently, the cutting-edge drug MGN1703 is being tested in 318 trials worldwide - 38 of those clinical studies are currently at Phase 3. Although most research centres are situated in Pittsburgh, Pennsylvania, there exist 20362 other locations that have trials available for this treatment."
Answered by AI
Is this trial currently recruiting participants?
"This trial has already ended recruitment. It was first posted on the 11th of May, 2016 and last updated February 11th 2022. However, there are 3124 studies for melanoma and 318 trials involving MGN1703 that remain open to participants."
Answered by AI
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