Advanced CancersPhase 1NCT02668770
Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies
A Phase 1 study testing MGN1703 and Ipilimumab in people with Advanced Cancers and Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Melanoma
- What is being tested?
- MGN1703 and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2016to 5 Nov 2025
- Phase
- Phase 1
- 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
- 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.
- There is no limit on the number of prior treatment regimens.
- Patients must be off prior chemotherapy, hormonal therapy, or biological therapy for at least 4 weeks or >3 half-lives whichever comes first. Patients with prostate cancer may continue to receive LHRH agonist (unless orchiectomy has been performed).
- ECOG performance status </= 2 (Karnofsky >60%).
- Patients must have adequate organ and marrow function as defined below within 7 days: WBC >/= 2500/mm^3. Absolute neutrophil count (ANC) >/= 1,500/mm^3. Absolute lymphocyte count (ALC) >/= 500/mm^3. Hemoglobin >/= 9g/dl. Platelets >/= 75,000/mm^3. Creatinine </= 2.0 x ULN or measured CrCl of >/= 50ml/m^2/1.73 m^2. Total bilirubin </= 2.0 mg/dL (unless previously diagnosed with Gilbert's Syndrome). AST(SGOT)/ALT(SGPT) </= 3 times the institutional upper limit of normal (patients with liver involvement will be allowed </= 5.0 X institutional upper normal limit).
- Patients must have recovered from toxicity related to prior therapy to at least grade 1 (defined by CTCAE 4.0) or baseline level. Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the Principal Investigator.
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- As the effect of these drugs on the developing human fetus is not known, women of child-bearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 months after completion.
- Female patient of childbearing potential has a negative serum pregnancy test within 7 days of study enrollment.
- Patients must be willing and able to review, understand, and provide written consent before study enrollment.
- Measurable disease as defined by irRC or RECIST 1.1 criteria
- Age >/= 18 years.
Who cannot join
- Severe autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study. Patients with history of mild autoimmune disorders - including but not limited to mild psoriasis or Hashimoto's hyperthyroidism may be included at the discretion of the principle investigator.
- History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
- Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs: e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies.
- Current evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B-C cirrhosis, active pancreatitis or uncontrolled medical disease which in the opinion of the investigator could compromise assessment of efficacy.
- Known human immunodeficiency virus (HIV)-positive and on highly active antiretroviral therapy (HAART), and/or Hepatitis B or C on treatment. Drug interactions between those agents and these experimental agents are wholly unknown (screening not required).
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days of day 1 of therapy.
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- Known hypersensitivity to the components of study drugs, its analogs, or drugs of similar chemical or biologic composition.
- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab).
- Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses).
- Radiation therapy within 4 weeks of study enrollment (exception is radiotherapy expansion arm which requires radiation treatment within 2 week period).
- Pregnant and breastfeeding women are excluded from this study. Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician.
- Use of any other concurrent investigational agents or anticancer agents including hormonal therapy, except in the case of prostate cancer patients who are being treated with LHRH agonist at the time of trial entry.
- Previous exposure to TLR agonist therapy.
- Known history of plasma cortisol and adrenocorticotropic hormone (ACTH) levels consistent with adrenal failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies
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.
Read the detailed description
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.
- Conditions
- Advanced Cancers, Melanoma
- Being tested
- MGN1703, Ipilimumab
- Keywords
- Advanced Cancers, Melanoma, Advanced solid malignancies, Metastatic, MGN1703, Ipilimumab, Yervoy, BMS-734016, MDX010, Refractory, Relapsed
- Medical subject headings
- Melanoma, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGN1703Drug
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.
IpilimumabDrug
Also called BMS-734016, Yervoy, MDX010
Dose Escalation and Dose Expansion Group Dose: 3 mg/kg by vein on Day 8 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Group: MGN1703 + Ipilimumab | Experimental | 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. Receives: Drug: MGN1703; Drug: Ipilimumab |
| MTD Group: MGN1703 (subcutaneously) + Ipilimumab | Experimental | 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. Receives: Drug: MGN1703; Drug: Ipilimumab |
| MTD Group: MGN1703 (intratumoral injection) + Ipilimumab | Experimental | 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. Receives: Drug: MGN1703; Drug: Ipilimumab |
| MTD Post XRT Group: MGN1703 (subcutaneously) + Ipilimumab | Experimental | 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. Receives: Drug: MGN1703; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of MGN1703 with Ipilimumab
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.
Measured: 84 days
Secondary outcomes (1)
Tumor Response
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.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start11 May 2016
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mologen AG
- Responsible party
- Sponsor
- Investigators
- David S. Hong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668770
- Sponsor's protocol ID
- 2015-0135
- Other IDs
- NCI-2016-00276
- Status last verified
- Nov 2025
- First submitted
- 26 Jan 2016
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nardo M, Gouda MA, Reilley MJ, Biter AB, Lim J, Bean SA, Nguyen LM, Bhosale PR, Ager CR, Couillault CA, Piha-Paul SA, Fu S, Tsimberidou AM, Yap TA, Naing A, Rodon J, Subbiah V, Karp DD, Curran MA, Hong DS. Lefitolimod in Combination with Ipilimumab in Patients with Advanced Solid Tumors: A Phase I Trial. J Immunother Precis Oncol. 2025 Feb 7;8(2):89-98. doi: 10.36401/JIPO-24-17. eCollection 2025 May.
PubMed 39959251
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT02668770
- Acronym / sponsor ID
- 2015-0135
- Conditions
- Advanced Cancers, Melanoma
- Keywords
- Advanced Cancers, Melanoma, Advanced solid malignancies, Metastatic, MGN1703, Ipilimumab, Yervoy, BMS-734016
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 28 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Mologen AG
- Study start
- 11 May 2016 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 29 Jan 2016 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Group: MGN1703 + Ipilimumab | Experimental | Drug: MGN1703, Drug: IpilimumabParticipants 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. |
| MTD Group: MGN1703 (subcutaneously) + Ipilimumab | Experimental | Drug: MGN1703, Drug: IpilimumabDose 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. |
| MTD Group: MGN1703 (intratumoral injection) + Ipilimumab | Experimental | Drug: MGN1703, Drug: IpilimumabDose 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. |
| MTD Post XRT Group: MGN1703 (subcutaneously) + Ipilimumab | Experimental | Drug: MGN1703, Drug: IpilimumabDose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- There is no limit on the number of prior treatment regimens.
- Patients must be off prior chemotherapy, hormonal therapy, or biological therapy for at least 4 weeks or >3 half-lives whichever comes first. Patients with prostate cancer may continue to receive LHRH agonist (unless orchiectomy has been performed).
- ECOG performance status </= 2 (Karnofsky >60%).
- Patients must have adequate organ and marrow function as defined below within 7 days: WBC >/= 2500/mm^3. Absolute neutrophil count (ANC) >/= 1,500/mm^3. Absolute lymphocyte count (ALC) >/= 500/mm^3. Hemoglobin >/= 9g/dl. Platelets >/= 75,000/mm^3. Creatinine </= 2.0 x ULN or measured CrCl of >/= 50ml/m^2/1.73 m^2. Total bilirubin </= 2.0 mg/dL (unless previously diagnosed with Gilbert's Syndrome). AST(SGOT)/ALT(SGPT) </= 3 times the institutional upper limit of normal (patients with liver involvement will be allowed </= 5.0 X institutional upper normal limit).
Key exclusion criteria (14 listed)
- Severe autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study. Patients with history of mild autoimmune disorders - including but not limited to mild psoriasis or Hashimoto's hyperthyroidism may be included at the discretion of the principle investigator.
- History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
- Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs: e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies.
- Current evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B-C cirrhosis, active pancreatitis or uncontrolled medical disease which in the opinion of the investigator could compromise assessment of efficacy.
- Known human immunodeficiency virus (HIV)-positive and on highly active antiretroviral therapy (HAART), and/or Hepatitis B or C on treatment. Drug interactions between those agents and these experimental agents are wholly unknown (screening not required).
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 |
|---|---|---|
| MGN1703Dose 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. | Drug | Dose Escalation Group: MGN1703 + Ipilimumab, MTD Group: MGN1703 (intratumoral injection) + Ipilimumab, MTD Group: MGN1703 (subcutaneously) + Ipilimumab, MTD Post XRT Group: MGN1703 (subcutaneously) + Ipilimumab |
| IpilimumabAlso: BMS-734016, Yervoy, MDX010Dose Escalation and Dose Expansion Group Dose: 3 mg/kg by vein on Day 8 of a 21 day cycle. | Drug | Dose Escalation Group: MGN1703 + Ipilimumab, MTD Group: MGN1703 (intratumoral injection) + Ipilimumab, MTD Group: MGN1703 (subcutaneously) + Ipilimumab, MTD Post XRT Group: MGN1703 (subcutaneously) + Ipilimumab |
Primary outcome
Maximum Tolerated Dose (MTD) of MGN1703 with Ipilimumab
Time frame: 84 days
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.
1 secondary outcome
Tumor Response
Time frame: 84 days
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 39959251Nardo M, Gouda MA, Reilley MJ, Biter AB, Lim J, Bean SA, Nguyen LM, Bhosale PR, Ager CR, Couillault CA, Piha-Paul SA, Fu S, Tsimberidou AM, Yap TA, Naing A, Rodon J, Subbiah V, Karp DD, Curran MA, Hong DS. Lefitolimod in Combination with Ipilimumab in Patients with Advanced Solid Tumors: A Phase I Trial. J Immunother Precis Oncol. 2025 Feb 7;8(2):89-98. doi: 10.36401/JIPO-24-17. eCollection 2025 May.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
David S. Hong, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGN1703 and Ipilimumab in people with Advanced Cancers and Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 11 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: \<75% participation). Results are not available in the source record.
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?
Maximum Tolerated Dose (MTD) of MGN1703 with Ipilimumab (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668770, which also lists 1 linked publication.
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 7 Apr 2026.