Trial Outcomes & Findings for Neoadjuvant Immunotherapy in Brain Metastases (NCT NCT04434560)
NCT ID: NCT04434560
Last Updated: 2022-07-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
10 days
Results posted on
2022-07-26
Participant Flow
In a Memo to File dated March 4, 2021, the removal of randomization in favor of a single-arm study in which all patients will receive neoadjuvant immunotherapy prior to their resection and SRS was proposed. One patient had already been randomized to receive standard of care surgery and SRS without neoadjuvant immunotherapy. This patient is not part of the analyses for the primary or secondary outcomes, as after the protocol amendment all patients were to receive neoadjuvant immunotherapy.
Participant milestones
| Measure |
Standard of Care (no Neoadjuvant Immunotherapy)
Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
|
Neoadjuvant Immunotherapy
Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.
Nivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg.
Ipilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Immunotherapy in Brain Metastases
Baseline characteristics by cohort
| Measure |
Standard of Care (no Neoadjuvant Immunotherapy)
n=1 Participants
Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
|
Neoadjuvant Immunotherapy
Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.
Nivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg.
Ipilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
|
Total
n=1 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Outcome measure only applies to Neoadjuvant Immunotherapy; no participants were enrolled in the Neoadjuvant Immunotherapy group.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to day 1Population: Outcome measure only applies to Neoadjuvant Immunotherapy; no participants were enrolled in the Neoadjuvant Immunotherapy group.
Ki-67 is a nuclear protein involved in cell proliferation regulation.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care (no Neoadjuvant Immunotherapy)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Neoadjuvant Immunotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care (no Neoadjuvant Immunotherapy)
n=1 participants at risk
Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
|
Neoadjuvant Immunotherapy
Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.
Nivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg.
Ipilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
|
|---|---|---|
|
Nervous system disorders
Pyramidal tract syndrome
|
100.0%
1/1 • Number of events 1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
Other adverse events
| Measure |
Standard of Care (no Neoadjuvant Immunotherapy)
n=1 participants at risk
Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
|
Neoadjuvant Immunotherapy
Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.
Nivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg.
Ipilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Endocrine disorders
Hypothyroidism
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Nervous system disorders
Concentration impairment
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Nervous system disorders
Dysphasia
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Nervous system disorders
Paresthesia
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
100.0%
1/1 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
—
0/0 • Approximately 10 days
No participants were enrolled in the Neoadjuvant Immunotherapy group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place