Trial Outcomes & Findings for TIL Therapy in Combination With Checkpoint Inhibitors for Metastatic Ovarian Cancer (NCT NCT03287674)
NCT ID: NCT03287674
Last Updated: 2023-03-01
Results Overview
Determine the safety of TIL therapy in combination with checkpoint inhibitors for patients with ovarian-, fallopian tube or primary peritoneal cancer by reporting adverse events according to CTCAE v. 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
TIL Treated Patients
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
All Treated With TILs
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TIL Treated Patients
n=6 Participants
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Denmark
|
6 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsDetermine the safety of TIL therapy in combination with checkpoint inhibitors for patients with ovarian-, fallopian tube or primary peritoneal cancer by reporting adverse events according to CTCAE v. 4.0.
Outcome measures
| Measure |
TIL Treated Patients
n=6 Participants
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Number of Participants With Reported Adverse Events by Type
Agammaglobulinemia
|
1 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Dyspnea
|
1 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Performance status drop
|
3 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Fatigue
|
3 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Nausea
|
1 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Vomiting
|
1 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Diarrhea
|
1 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Hyponatremia
|
3 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Infection
|
2 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Neutropenia
|
6 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Trombocytopenia
|
6 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Anemia
|
6 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Fever
|
3 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Colitis
|
1 Participants
|
|
Number of Participants With Reported Adverse Events by Type
Dry skin
|
1 Participants
|
SECONDARY outcome
Timeframe: Until protocol end, until 6 months after TIL infusionEx vivo anti-tumor reactivity of expanded TILs after co-culture measured with flow cytometry.
Outcome measures
| Measure |
TIL Treated Patients
n=6 Participants
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Treatment Related Immune Responses
|
6 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 12 months after therapy.Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CAT scan: Complete Response (CR) Disappearance of all target lesions (sum of all taget lesions=0) Partial Response (PR) \>=30% decrease (vs baseline) of sum of all target lesions dimension Progressive Disease (PD) new lesions or \>=20% increase (vs smallest sum of target lesions or nadir) Stable Disease (SD) when sum of all target lesions does not qualify for CR/PR/PD
Outcome measures
| Measure |
TIL Treated Patients
n=6 Participants
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Objective Response Rate
Complete response
|
0 Participants
|
|
Objective Response Rate
Partial response
|
1 Participants
|
|
Objective Response Rate
Stabile disease
|
5 Participants
|
|
Objective Response Rate
Progressive disease
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years after TIL infusionOverall Survival (OS), defined as time from TIL infusion to death
Outcome measures
| Measure |
TIL Treated Patients
n=6 Participants
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Overall Survival
|
247 Days
Interval 136.0 to 915.0
|
SECONDARY outcome
Timeframe: Up to 12 months after TIL infusionProgression free survival (PFS): Time from TIL infusion to disease progression, relapse or death due to any cause, which ever comes first, will be used as an event.
Outcome measures
| Measure |
TIL Treated Patients
n=6 Participants
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Progression Free Survival
|
93 Days
Interval 84.0 to 342.0
|
Adverse Events
TIL Treated Patients
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
TIL Treated Patients
n=6 participants at risk
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Immune system disorders
Colitis
|
16.7%
1/6 • Number of events 1 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Blood and lymphatic system disorders
Agammaglobulimia
|
16.7%
1/6 • Number of events 1 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Renal and urinary disorders
Infection
|
16.7%
1/6 • Number of events 2 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Respiratory, thoracic and mediastinal disorders
Infection
|
16.7%
1/6 • Number of events 1 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
General disorders
Nausea
|
16.7%
1/6 • Number of events 2 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 2 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Renal and urinary disorders
Hyponatremia
|
50.0%
3/6 • Number of events 3 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
6/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Blood and lymphatic system disorders
Trombocytopenia
|
100.0%
6/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
6/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
General disorders
Fever
|
50.0%
3/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
Other adverse events
| Measure |
TIL Treated Patients
n=6 participants at risk
Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
General disorders
nausea
|
83.3%
5/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Endocrine disorders
Thyroiditis
|
16.7%
1/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Infections and infestations
Infection
|
33.3%
2/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Gastrointestinal disorders
diarrhea
|
100.0%
6/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Gastrointestinal disorders
Oral mucositis
|
50.0%
3/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Gastrointestinal disorders
Obstipation
|
33.3%
2/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
4/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
16.7%
1/6 • From first therapy and until discontinuation from protocol - up to 12 months after.
Adverse event above grade 2 (CTCAE 4.0)
|
Additional Information
Anders Kverneland, MD
National Center for Cancer Immune Therapy, Herlev Hospital
Phone: 38686467
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place