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Experimental combo targets tough tumors

NCT ID NCT02668770

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug combination (MGN1703 plus ipilimumab) in people with advanced solid tumors that had stopped responding to standard treatments. The main goal was to find the safest dose of MGN1703 when given with ipilimumab. The study was stopped early, but results may help guide future research.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

28 people

The number who actually took part.

Started

May 2016

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. There is no limit on the number of prior treatment regimens. 3. 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). 4. ECOG performance status \</= 2 (Karnofsky \>60%). 5. 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). 6. 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. 7. 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. 8. Female patient of childbearing potential has a negative serum pregnancy test within 7 days of study enrollment. 9. Patients must be willing and able to review, understand, and provide written consent before study enrollment. 10. Measurable disease as defined by irRC or RECIST 1.1 criteria 11. Age \>/= 18 years. Exclusion Criteria: 1. 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. 2. History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation. 3. 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. 4. 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. 5. 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). 6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days of day 1 of therapy. 7. Known hypersensitivity to the components of study drugs, its analogs, or drugs of similar chemical or biologic composition. 8. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab). 9. 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). 10. Radiation therapy within 4 weeks of study enrollment (exception is radiotherapy expansion arm which requires radiation treatment within 2 week period). 11. 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. 12. 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. 13. Previous exposure to TLR agonist therapy. 14. Known history of plasma cortisol and adrenocorticotropic hormone (ACTH) levels consistent with adrenal failure.

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Conditions

The condition(s) this trial relates to.

cancer melanoma neoplasm Neoplasm Metastasis Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.