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Last Updated: April 21, 2021

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CLINICAL TRIALS PROFILE FOR IPILIMUMAB

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All Clinical Trials for ipilimumab

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00060372 Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer Completed National Cancer Institute (NCI) Phase 1 2003-04-01 This phase I trial is studying how well ipilimumab works after allogeneic stem cell transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
NCT00094653 MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma Completed Bristol-Myers Squibb Phase 3 2004-09-01 The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.
NCT00113984 Vaccine and Antibody Treatment of Prostate Cancer Completed National Cancer Institute (NCI) Phase 1 2005-06-01 This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The vaccine consists of a "priming vaccine" called PROSTVAC/TRICOM, made from vaccinia virus, and a "boosting vaccine" called PROSTVAC-F/TRICOM, made from fowlpox virus. GM-CSF is a chemical that boosts the immune system, and anti-CTLA-4 antibody is a protein that may improve anti-tumor activity and the response to the vaccines. DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA)-a protein that is normally produced by the patient's tumor cells. Patients 18 years of age and older with androgen-insensitive prostate cancer that has spread beyond the original site may be eligible for this 7-month study. Candidates must have disease that has worsened despite treatments with hormones and up to one chemotherapy regimen. Their tumor must produce PSA, and they must have no history of allergy to eggs or egg products Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, pathological confirmation of the diagnosis and presence of the PSA marker, chest x-rays, imaging studies to assess the extent of tumor, and, if clinically indicated, a cardiologic evaluation. Participants receive the priming vaccination on study day 1. After 2 weeks and then again every 4 weeks while on the study, they receive a boosting vaccine. All vaccines are injected under the skin. On the day of each vaccination and daily for the next 3 days, patients receive an injection of GM-CSF to increase the number of immune cells at the vaccination site. On the day of the first six boosting vaccinations, they receive anti-CTLA-4 antibody as an infusion through a vein over 90 minutes. Patients are monitored for safety and treatment response with the following tests and procedures: - Blood and urine tests monthly, or more often if needed, to monitor liver, kidney, and other organ function. - Imaging studies to assess the tumor before starting treatment, again around study days 99 and 183, and then every 3 months after that while on study. - Apheresis (a procedure for collecting immune cells called lymphocytes) to measure the immune response to treatment. Apheresis is done three times: before starting the study and again around study days 99 and 183. For this procedure, blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components by spinning, and the lymphocytes are extracted. The rest of the blood is returned to the patient through the same needle. This will only be done in participants who have the tissue marker HLA-A2 (about 50% of patients). Patients whose disease responds to treatment and who do not develop severe side effects may continue treatment beyond the initial 7-month study period on vaccine alone (without the antibody). After treatment is completed, patients are monitored for up to 15 years. This includes a medical history and physical examination for 5 years following the last vaccination. Information beyond 5 years is collected once a year by telephone.
NCT00162123 A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies Completed Bristol-Myers Squibb Phase 2 2006-05-01 The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.
NCT00261365 Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010) Completed Bristol-Myers Squibb Phase 1/Phase 2 2005-11-01 The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
NCT00289627 A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma Completed Medarex Phase 2 2006-04-01 The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
NCT00289627 A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma Completed Bristol-Myers Squibb Phase 2 2006-04-01 The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ipilimumab

Condition Name

Condition Name for ipilimumab
Intervention Trials
Melanoma 92
Metastatic Melanoma 37
Prostate Cancer 19
Renal Cell Carcinoma 16
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Condition MeSH

Condition MeSH for ipilimumab
Intervention Trials
Melanoma 177
Carcinoma 68
Lung Neoplasms 46
Carcinoma, Renal Cell 42
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Clinical Trial Locations for ipilimumab

Trials by Country

Trials by Country for ipilimumab
Location Trials
Japan 127
Australia 118
United Kingdom 112
Canada 94
Brazil 73
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Trials by US State

Trials by US State for ipilimumab
Location Trials
California 102
Texas 95
New York 95
Pennsylvania 77
Massachusetts 72
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Clinical Trial Progress for ipilimumab

Clinical Trial Phase

Clinical Trial Phase for ipilimumab
Clinical Trial Phase Trials
Phase 4 3
Phase 3 44
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for ipilimumab
Clinical Trial Phase Trials
Not yet recruiting 194
Recruiting 188
Active, not recruiting 52
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Clinical Trial Sponsors for ipilimumab

Sponsor Name

Sponsor Name for ipilimumab
Sponsor Trials
Bristol-Myers Squibb 218
National Cancer Institute (NCI) 47
M.D. Anderson Cancer Center 35
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Sponsor Type

Sponsor Type for ipilimumab
Sponsor Trials
Other 438
Industry 368
NIH 49
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