Trial Outcomes & Findings for Ipilimumab and Local Radiation for Selected Solid Tumors (NCT NCT01769222)

Last Updated: 2024-01-24

Results Overview

Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	Ipilimumab 25 mg Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally	Ipilimumab 25 mg and Radiation Therapy Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
Study Phase 1 STARTED	3	0
Study Phase 1 COMPLETED	3	0
Study Phase 1 NOT COMPLETED	0	0
Study Phase 2 STARTED	0	0
Study Phase 2 COMPLETED	0	0
Study Phase 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ipilimumab and Local Radiation for Selected Solid Tumors

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 4 weeks

Population: This study did not proceed to Phase 2 (ipilimumab plus radiation combination therapy).

Outcome measures

Outcome measures
Measure	Ipilimumab 25 mg n=3 Participants Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally	Ipilimumab 25 mg and Radiation Therapy Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
Dose-limiting Toxicity	0 percentage of participants	—

SECONDARY outcome

Timeframe: 4 weeks

Population: This was a study phase 2 outcome, and no participants were enrolled in study phase 2.

Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: This was a study phase 2 outcome, and no participants were enrolled in study phase 2.

Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: This was a study phase 2 outcome, and no participants were enrolled in study phase 2.

Data will be summarized using Kaplan-Meier estimates for time to event data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: This was a study phase 2 outcome, and no participants were enrolled in study phase 2.

Data will be summarized using Kaplan-Meier estimates for time to event data.

Outcome measures

Outcome data not reported

Adverse Events

Ipilimumab 25 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ipilimumab 25 mg and Radiation Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ipilimumab 25 mg n=3 participants at risk Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally	Ipilimumab 25 mg and Radiation Therapy Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
Skin and subcutaneous tissue disorders Pain, injection site	33.3% 1/3 • Number of events 1	— 0/0

Additional Information

George Albert Fisher, MD

Stanford University Medical Center

Phone: 650-725-9057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ipilimumab 25 mg n=3 Participants Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally	Ipilimumab 25 mg and Radiation Therapy Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions	Total n=3 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants	—	61 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	—	3 Participants n=5 Participants