Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (NCT02668770) | Clinical Trial Compass
TerminatedPhase 1
Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies
Stopped: \<75% participation
United States28 participantsStarted 2016-05-11
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
What they're measuring
1
Maximum Tolerated Dose (MTD) of MGN1703 with Ipilimumab
✓. 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.
Exclusion criteria
✕. 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.
✕. 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).