Trial Outcomes & Findings for Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs) (NCT NCT04375228)
NCT ID: NCT04375228
Last Updated: 2026-08-03
Results Overview
The percentage of participants able to discontinue steroid treatment within 4 weeks after the last dose of Rituximab.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 8 weeks
Results posted on
2026-08-03
Participant Flow
No participants were eligible for assignment to the Rituximab Arm
Participant milestones
| Measure |
Tocilizumab
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Tocilizumab.
|
Rituximab
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Tocilizumab
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Tocilizumab.
|
Rituximab
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
3 participants had arthritis and 3 participants had dermatitis at baseline
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=6 Participants
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Tocilizumab.
|
|---|---|
|
Age, Continuous
|
72 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
|
Primary immune mediated adverse event Baseline CTCAE Grade
Arthritis · Grade 1
|
2 Participants
n=3 Participants • 3 participants had arthritis and 3 participants had dermatitis at baseline
|
|
Primary immune mediated adverse event Baseline CTCAE Grade
Arthritis · Grade 2
|
1 Participants
n=3 Participants • 3 participants had arthritis and 3 participants had dermatitis at baseline
|
|
Primary immune mediated adverse event Baseline CTCAE Grade
Dermatitis · Grade 1
|
0 Participants
n=3 Participants • 3 participants had arthritis and 3 participants had dermatitis at baseline
|
|
Primary immune mediated adverse event Baseline CTCAE Grade
Dermatitis · Grade 2
|
3 Participants
n=3 Participants • 3 participants had arthritis and 3 participants had dermatitis at baseline
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: No participants were eligible for assignment to the Rituximab Arm. Data could not be collected for this outcome.
The percentage of participants able to discontinue steroid treatment within 4 weeks after the last dose of Rituximab.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 12 weeksThe number of participants able to discontinue steroid treatment within 4 weeks after the last dose of Tocilizumab.
Outcome measures
| Measure |
Rituximab
n=6 Participants
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
|
|---|---|
|
Number of Participants to Discontinue Steroid Treatment After Tocilizumab
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksThe number of participants with an irAE grade improvement per Common Terminology Criteria for Adverse Events (CTCAE) version 5
Outcome measures
| Measure |
Rituximab
n=6 Participants
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
|
|---|---|
|
Number of Participants With a Change in CTCAE (v5.0) Grade
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksTo evaluate the safety of rituximab and tocilizumab defined as the number of steroid-dependent immune-related adverse events.
Outcome measures
| Measure |
Rituximab
n=6 Participants
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
|
|---|---|
|
Number of Steroid-Dependent Immune-Related Adverse Events
|
0 Participants
|
Adverse Events
Tocilizumab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tocilizumab
n=6 participants at risk
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Tocilizumab.
|
|---|---|
|
Blood and lymphatic system disorders
increase in INR
|
16.7%
1/6 • Up to 24 weeks
|
|
Hepatobiliary disorders
increase in bilirubin
|
16.7%
1/6 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
50.0%
3/6 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
50.0%
3/6 • Up to 24 weeks
|
Additional Information
Study Principal Investigator
Columbia University Irving Medical Center
Phone: (212) 342-5162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place