A Phase 2 interventional study of Ipilimumab and Stereotactic Radiosurgery in Metastatic Melanoma and Brain Metastases, sponsored by University of Michigan Rogel Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
This is a study to test the efficacy of using standard immune therapy for melanoma prior to stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good as or better than controlling brain metastases as compared to stereotactic radiosurgery followed by immune therapy.
This is a randomized Phase II selection study investigating the use of ipilimumab induction prior to stereotactic radiosurgery (SRS), versus no induction, for melanoma brain metastases. Participants will be randomized to Arm A "Induction" (two doses of ipilimumab prior to SRS, two doses of ipilimumab after SRS) versus Arm B "No induction" (SRS first, followed by 4 doses of ipilimumab). Participants will undergo multiple dynamic contrast-enhanced MRIs of the brain and submit blood samples for immune testing.
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 4 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University of Michigan Rogel Cancer Center is the lead sponsor of 317 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.
Drug: Ipilimumab · Procedure: Stereotactic Radiosurgery
Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.
Drug: Ipilimumab · Procedure: Stereotactic Radiosurgery
Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.
Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours.
Local Control Rate
The number of patients in each arm who are free from progression in the index (radiated) lesions in the brain at 6 months. Immune related response criteria was used to assess response to treatment. Immune-related Progressive Disease (irPD) in this trial is defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented.
Time frame: 6 months
Overall Survival Rate
Number of participants alive at 5 years after enrollment.
Time frame: Up to 5 years
Regional (Intracranial) Control Rate
The proportion of patients in each arm who are free from progression in the index (radiated) lesions and free from new brain metastases at 6 months.
Time frame: 6 months
Intracranial Response Rate
Response of treated (irradiated) brain metastases to combination therapy with ipilimumab and stereotactic radiosurgery using immune-related response criteria.
Time frame: Up to 12 months
Time to Progression
Time to progression in the brain due to treated metastases or new brain metastases. Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) was used to assess response. Progression was defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 wk from the date first documented.
Time frame: From date of enrollment to up to 2 years
Imaging Correlates on Dynamic-contrast Enhanced MRI of the Brain
Exploratory endpoints: Interval changes in dynamic MRI parameters such as perfusion, blood volume, vascular permeability (Ktrans), and diffusion tensor imaging; the change in 3D tumor volume.
Time frame: 6 months
Immune Correlates
Exploratory endpoints: Interval changes in immune markers in the blood
Time frame: 6 months
| Milestone | B: No Induction | A: Induction |
|---|---|---|
| Started | 1 | 3 |
| Completed | 1 | 3 |
| Not completed | 0 | 0 |
The number of patients in each arm who are free from progression in the index (radiated) lesions in the brain at 6 months. Immune related response criteria was used to assess response to treatment. Immune-related Progressive Disease (irPD) in this trial is defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented.
| Participants | B: No Induction | A: Induction |
|---|---|---|
| Local Control Rate | 1 | 3 |
Number of participants alive at 5 years after enrollment.
| participants | B: No Induction | A: Induction |
|---|---|---|
| Overall Survival Rate | 1 | 2 |
The proportion of patients in each arm who are free from progression in the index (radiated) lesions and free from new brain metastases at 6 months.
| Participants | B: No Induction | A: Induction |
|---|---|---|
| Regional (Intracranial) Control Rate | 1 | 3 |
Response of treated (irradiated) brain metastases to combination therapy with ipilimumab and stereotactic radiosurgery using immune-related response criteria.
| Participants | B: No Induction | A: Induction |
|---|---|---|
| Intracranial Response Rate | 1 | 3 |
Time to progression in the brain due to treated metastases or new brain metastases. Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) was used to assess response. Progression was defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 wk from the date first documented.
| participants | B: No Induction | A: Induction |
|---|---|---|
| 5 months, 27 days | 0 | 1 |
| 19 months, 3 days | 1 | 0 |
Exploratory endpoints: Interval changes in dynamic MRI parameters such as perfusion, blood volume, vascular permeability (Ktrans), and diffusion tensor imaging; the change in 3D tumor volume.
Results for this outcome have not been posted.
Exploratory endpoints: Interval changes in immune markers in the blood
Results for this outcome have not been posted.
Collected over Adverse events were collected up to 6 months after study start. All-cause mortality is observed up to 5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ipilimumab and SRS | 1/4 (25%) | 0/4 (0%) | 4/4 (100%) |
| Event | Ipilimumab and SRS |
|---|---|
| FatigueGeneral disorders | 3/4 |
| ConstipationGastrointestinal disorders | 2/4 |
| DiarrheaGastrointestinal disorders | 2/4 |
| DizzinessNervous system disorders | 2/4 |
| HeadacheNervous system disorders | 2/4 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 2/4 |
| Alanine aminotransferase increasedInvestigations | 1/4 |
| Concentration impairmentPsychiatric disorders | 1/4 |
| Creatinine increasedInvestigations | 1/4 |
| DepressionPsychiatric disorders | 1/4 |
| Age, Continuous(years) | B: No Induction | A: Induction | Total |
|---|---|---|---|
| Mean | 69 (69 to 69) | 55 (48 to 62) | 58 (48 to 69) |
| Sex: Female, Male(Participants) | B: No Induction | A: Induction | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 1 | 2 | 3 |
This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center