Trial Outcomes & Findings for Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma (NCT NCT01703507)

Last Updated: 2025-05-16

Results Overview

(MTD) when combined with WBRT or SRS, defined as the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

30 days following the completion of radiation therapy

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Overall Study STARTED	6	11
Overall Study COMPLETED	5	11
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=6 Participants Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=11 Participants Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	11 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days following the completion of radiation therapy

(MTD) when combined with WBRT or SRS, defined as the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose

Outcome measures

Outcome measures
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=5 Participants Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=11 Participants Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Maximum Tolerated Dose (MTD) of Ipilimumab	3 mg/kg	10 mg/kg

SECONDARY outcome

Timeframe: Up to 5 years

Population: Of the enrolled participants, only 7 developed new Brain Metastases (BMs) and were included in this analysis.

Outcome measures

Outcome measures
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=1 Participants Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=6 Participants Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Rate of Developing New Brain Metastases in Each Arm	8.2 months Interval 8.2 to 8.2	1.9 months Interval 0.97 to 8.2

SECONDARY outcome

Timeframe: Up to 5 years

Population: Of the enrolled participants, only 4 out of 5 participants on Arm A and 9 out of 11 participants on Arm B had Extracranial Disease. Only these participants were included in this analysis

Extracranial disease is assessed through repeated computed tomography of the chest, abdomen, and pelvis. The purpose of this scan is to determine if there is any evidence of disease outside of the brain.

Outcome measures

Outcome measures
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=4 Participants Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=9 Participants Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Number of Subjects With Response of Extracranial Disease	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=5 Participants Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=11 Participants Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Overall Survival (OS) Rate	8 months Interval 3.5 to 24.1	10.5 months Interval 1.8 to 36.8

SECONDARY outcome

Timeframe: Up to 5 years

PFS rate based on Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC) criteria based on the brain MRI and systematic assessment by the treating physician

Outcome measures

Outcome measures
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=5 Participants Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=11 Participants Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Number of Patients With Progression Free Survival (PFS) Rate	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks following the last dose of ipilimumab

Outcome measures

Outcome measures
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=5 Participants Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=11 Participants Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Number of Participants With Adverse Events and Serious Adverse Events	1 Participants	4 Participants

Adverse Events

Arm A (Ipilimumab and Whole Brain Radiation Therapy)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 3 deaths

Arm B (Ipilimumab and Stereotactic Radiosurgery)

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=5 participants at risk Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=11 participants at risk Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
Gastrointestinal disorders diarrhea	20.0% 1/5 • Number of events 1 • 30 days after completion of radiation therapy (RT)	36.4% 4/11 • Number of events 4 • 30 days after completion of radiation therapy (RT)

Other adverse events

Additional Information

Dr. Wenyin Shi

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-6702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A (Ipilimumab and Whole Brain Radiation Therapy) n=5 participants at risk Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2. Ipilimumab: Given IV Whole-Brain Radiation Therapy (WBRT): Undergo WBRT	Arm B (Ipilimumab and Stereotactic Radiosurgery) n=11 participants at risk Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1. Ipilimumab: Given IV Stereotactic Radiosurgery (SRS): Undergo SRS
General disorders headache	40.0% 2/5 • 30 days after completion of radiation therapy (RT)	36.4% 4/11 • 30 days after completion of radiation therapy (RT)
General disorders fatigue	20.0% 1/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
Ear and labyrinth disorders Changes in Hearing	40.0% 2/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
Gastrointestinal disorders Diarrhea	40.0% 2/5 • 30 days after completion of radiation therapy (RT)	27.3% 3/11 • 30 days after completion of radiation therapy (RT)
Metabolism and nutrition disorders Anoerexia	40.0% 2/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
General disorders hot flashes	20.0% 1/5 • 30 days after completion of radiation therapy (RT)	0.00% 0/11 • 30 days after completion of radiation therapy (RT)
Gastrointestinal disorders Constipation	20.0% 1/5 • 30 days after completion of radiation therapy (RT)	0.00% 0/11 • 30 days after completion of radiation therapy (RT)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
Eye disorders Vision Changes	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
Vascular disorders hypertension	40.0% 2/5 • 30 days after completion of radiation therapy (RT)	0.00% 0/11 • 30 days after completion of radiation therapy (RT)
General disorders Alopecia	40.0% 2/5 • 30 days after completion of radiation therapy (RT)	0.00% 0/11 • 30 days after completion of radiation therapy (RT)
Blood and lymphatic system disorders Anemia	20.0% 1/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
General disorders Dizziness	20.0% 1/5 • 30 days after completion of radiation therapy (RT)	0.00% 0/11 • 30 days after completion of radiation therapy (RT)
Musculoskeletal and connective tissue disorders Bone Pain	20.0% 1/5 • 30 days after completion of radiation therapy (RT)	0.00% 0/11 • 30 days after completion of radiation therapy (RT)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
General disorders Depression	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
Hepatobiliary disorders Lipase Increase	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
General disorders Weakness	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
Nervous system disorders Seizure	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
Nervous system disorders Facial Palsy	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)
General disorders Pleural effusion	0.00% 0/5 • 30 days after completion of radiation therapy (RT)	9.1% 1/11 • 30 days after completion of radiation therapy (RT)