Trial Outcomes & Findings for T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer (NCT NCT03318900)
NCT ID: NCT03318900
Last Updated: 2024-11-07
Results Overview
Due to lack of funding, the study was not able to accrue a sample size large enough to address the primary and secondary objectives
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
will continue to be monitored on study with visits every 8 weeks or as often as clinically indicated unless the disease gets worse, participants starts another therapy, or the participants are taken off study
Results posted on
2024-11-07
Participant Flow
The study was activated on 07/16/2018 and the first participant was enrolled on 09/04/2018. The study was completd on 09/04/2020 when the last particiapnt treated was taken off study and the study was terminated on 12/20/2023. All screening and recruitment was done in a medical clinic setting.
Participant milestones
| Measure |
Dose Level 1
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T-Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days
|
Dose Level 2
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; low-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
Dose Level 3
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; high-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
0
|
|
Overall Study
COMPLETED
|
3
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T-Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days
|
Dose Level 2
n=2 Participants
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; low-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
Dose Level 3
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; high-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
—
|
5 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: will continue to be monitored on study with visits every 8 weeks or as often as clinically indicated unless the disease gets worse, participants starts another therapy, or the participants are taken off studyPopulation: Data were not collected due to lack of funding; the study was not able to accrue a sample size large enough to address the primary and secondary objectives
Due to lack of funding, the study was not able to accrue a sample size large enough to address the primary and secondary objectives
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: will continue to be monitored on study with visits every 8 weeks or as often as clinically indicated unless the disease gets worse, participants starts another therapy, or the participants are taken off studyPopulation: Data were not collected due to lack of funding; the study was not able to accrue a sample size large enough to address the primary and secondary objectives
Due to lack of funding, the study was not able to accrue a sample size large enough to address the primary and secondary objectives
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T-Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days
|
Dose Level 2
n=2 participants at risk
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; low-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
Dose Level 3
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; high-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T-Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days
|
Dose Level 2
n=2 participants at risk
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; low-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
Dose Level 3
Cyclophosphamide (300 mg/m2) IV 2 days prior to infusion of T Cells IV on Day 0 followed by IL-2 SC injections every 12 hours for 14 days; high-dose anti-CD137 IV beginning on Day 1 and then every 4 weeks x6 doses
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Through study completion, an average of 18 months
CTCAE V5.0
|
100.0%
2/2 • Number of events 2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 3 • Through study completion, an average of 18 months
CTCAE V5.0
|
100.0%
2/2 • Number of events 2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Through study completion, an average of 18 months
CTCAE V5.0
|
50.0%
1/2 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
General disorders
Fatigue
|
0.00%
0/3 • Through study completion, an average of 18 months
CTCAE V5.0
|
50.0%
1/2 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Through study completion, an average of 18 months
CTCAE V5.0
|
50.0%
1/2 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Investigations
Neutrophil count increased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • Through study completion, an average of 18 months
CTCAE V5.0
|
50.0%
1/2 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
0.00%
0/2 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Through study completion, an average of 18 months
CTCAE V5.0
|
50.0%
1/2 • Number of events 1 • Through study completion, an average of 18 months
CTCAE V5.0
|
—
0/0 • Through study completion, an average of 18 months
CTCAE V5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place