Pilot Ipilimumab in Stage IV Melanoma Receiving Palliative Radiation Therapy
|ClinicalTrials.gov Identifier: NCT01449279|
Recruitment Status : Active, not recruiting
First Posted : October 10, 2011
Results First Posted : March 10, 2017
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Ipilimumab Radiation: Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Ipilimumab in Subjects With Stage IV Melanoma Receiving Palliative Radiation Therapy|
|Actual Study Start Date :||October 2011|
|Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 1, 2018|
Experimental: Ipilimumab Treatment + Radiation Therapy
Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1 to 2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2 to 4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Other Names:Radiation: Radiation Therapy
Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist.
- Safety Measurement - Percentage of Patients Experiencing Serious Adverse Events (SAEs) in the First 4 Months of Treatment. [ Time Frame: 4 months ]Serious adverse events (SAEs) defined as untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires in subject hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, may jeopardize the subject or may require intervention to prevent one of the other serious outcomes listed in the definition above.)
- Response Rate [ Time Frame: 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease ]
Compare tumor response rate and duration of response at unirradiated sites in patients with Stage IV melanoma with historical controls.
Response assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays:
- Complete Response (CR) = Disappearance of all target lesions
- Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
- Overall Response (OR) = CR + PR
- Overall Survival [ Time Frame: 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease ]Median time to overall survival was calculated using the Kaplan-Meier algorithm.
- Duration of Complete Response [ Time Frame: 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease ]The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.
- Duration of Partial Response. [ Time Frame: 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. ]Length of time between first dose of ipilimumab and a partial response according to RECIST v1.1 (see above) and immune response criteria
- Stable Disease [ Time Frame: 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. ]Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements
- Median Time to Complete Response or Partial Response [ Time Frame: 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. ]Time from the first dose of ipilimumab to the first tumor measurement showing either a complete or partial response to therapy.
- Progression-free Survival (PFS) [ Time Frame: 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. ]Median time to progression-free survival (PFS) was calculated using the Kaplan-Meier algorithm
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449279
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Susan J Knox, PhD, MD||Stanford University|