Trial Outcomes & Findings for T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer (NCT NCT04611126)
NCT ID: NCT04611126
Last Updated: 2025-08-12
Results Overview
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Until completion of the study for
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
Without Ipilimumab
At Step 1 the patients received:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
Due to the premature closure of the trial only 6 patients were enrolled.
|
With Ipilimumab
The trial was prematurely closed before step 2
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Without Ipilimumab
At Step 1 the patients received:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
Due to the premature closure of the trial only 6 patients were enrolled.
|
With Ipilimumab
The trial was prematurely closed before step 2
|
|---|---|---|
|
Overall Study
TIL expansion unsuccessful
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Without Ipilimumab
n=5 Participants
At Step one, 6 patients were enrolled. Due to one expansion failure 5 patients were treated with:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
|
With Ipilimumab
This step never started due to slow recruitment
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
—
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
|
0 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
5 participants
n=5 Participants
|
—
|
5 participants
n=5 Participants
|
|
Histology
High grade serous adenocarcinoma assessed by trained pathologist
|
2 participants
n=5 Participants
|
—
|
2 participants
n=5 Participants
|
|
Histology
Low grade serous adenocarcinoma assessed by trained pathologist
|
2 participants
n=5 Participants
|
—
|
2 participants
n=5 Participants
|
|
Histology
Undifferentiated carcinoma assessed by trained pathologist
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Number of prior treatment lines
|
3 lines
n=5 Participants
|
—
|
3 lines
n=5 Participants
|
|
Performance status assessed by the ECOG Performance Status Scale
ECOG PS 0
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Performance status assessed by the ECOG Performance Status Scale
ECOG PS 1
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until completion of the study forPopulation: The trial was prematurely closed due to slow patient recruitment. Thus, step 2 was never started.
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study
Outcome measures
| Measure |
Without Ipilimumab
n=6 Participants
At Step 1, 5 patients were treated with:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
|
With Ipilimumab
The trial was prematurely closed due to slow recruitment.
|
|---|---|---|
|
Number of Patients Excluded Due to Treatment Related Safety Issues
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until completion of the studyPopulation: The trial was prematurely closed due to slow patient recruitment. Thus, step 2 was never started.
The number of Participants Experiencing Grade III or Worse Adverse Events
Outcome measures
| Measure |
Without Ipilimumab
n=5 Participants
At Step 1, 5 patients were treated with:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
|
With Ipilimumab
The trial was prematurely closed due to slow recruitment.
|
|---|---|---|
|
Number of Participants Experiencing Grade III or Worse Adverse Events
Number of Participants Experiencing Grade III or Worse Adverse Events
|
5 Participants
|
0 Participants
|
|
Number of Participants Experiencing Grade III or Worse Adverse Events
Number of Participants with no Grade III or Worse Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until completion of the studyPopulation: The trial was prematurely closed due to slow patient recruitment. Thus, step 2 was never started.
Number of patients excluded due to feasibility issues compared to the number of patients enrolled in the study
Outcome measures
| Measure |
Without Ipilimumab
n=6 Participants
At Step 1, 5 patients were treated with:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
|
With Ipilimumab
The trial was prematurely closed due to slow recruitment.
|
|---|---|---|
|
Number of Patients Excluded Due to Feasibility Issues
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The patients were evaluated every 6-12 weeks after therapy and until study completionPopulation: The trial was prematurely closed due to slow patient recruitment. Thus, step 2 was never started.
Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) assessed by CT scan. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Without Ipilimumab
n=5 Participants
At Step 1, 5 patients were treated with:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
|
With Ipilimumab
The trial was prematurely closed due to slow recruitment.
|
|---|---|---|
|
Best Overall Response (BOR)
Stable disease
|
3 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Unconfirmed partial response
|
2 Participants
|
0 Participants
|
Adverse Events
Without Ipilimumab
Serious events: 5 serious events
Other events: 5 other events
Deaths: 4 deaths
With Ipilimumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Without Ipilimumab
n=5 participants at risk
At Step one, 6 patients were enrolled. Due to one expansion failure 5 patients were treated with:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
|
With Ipilimumab
The trial was prematurely closed due to slow patient recruitment. Thus, step 2 was never started.
|
|---|---|---|
|
Infections and infestations
Bacterial infection
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Ileus (small intestine)
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Cardiac disorders
Atrial febrillation
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Colon ileus
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Gastroenteritis
|
20.0%
1/5 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Kidney failure
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Cardiac disorders
Pericardial effusion
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Endocrine disorders
Hyperthyroidism
|
20.0%
1/5 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Infections and infestations
Bacterial infection during neutropenia
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Infections and infestations
Reactivation of Cytomegalo virus
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
Other adverse events
| Measure |
Without Ipilimumab
n=5 participants at risk
At Step one, 6 patients were enrolled. Due to one expansion failure 5 patients were treated with:
Cyclophosphamid: Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine Phosphate: Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusion: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Nivolumab: Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
Relatlimab: Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
|
With Ipilimumab
The trial was prematurely closed due to slow patient recruitment. Thus, step 2 was never started.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
5/5 • Number of events 5 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
5/5 • Number of events 8 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
5/5 • Number of events 7 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Blood and lymphatic system disorders
Hyponetriemia
|
100.0%
5/5 • Number of events 7 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 6 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Blood and lymphatic system disorders
Trombocytopenia
|
100.0%
5/5 • Number of events 7 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Decrease in PS
|
100.0%
5/5 • Number of events 9 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Fatique
|
100.0%
5/5 • Number of events 9 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Infections and infestations
Infections
|
60.0%
3/5 • Number of events 7 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 3 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 3 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Obstipation
|
60.0%
3/5 • Number of events 3 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Dry mouth
|
40.0%
2/5 • Number of events 4 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
2/5 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Hepatobiliary disorders
Elevated ALAT/ASAT
|
40.0%
2/5 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Blood and lymphatic system disorders
Increased p-ferritin
|
20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Infections and infestations
Oral candida
|
20.0%
1/5 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Fever
|
80.0%
4/5 • Number of events 7 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
40.0%
2/5 • Number of events 3 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
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Cardiac disorders
Troponine increase
|
20.0%
1/5 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
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Blood and lymphatic system disorders
Increased ferritin
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20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
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Renal and urinary disorders
Elevated creatinine
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20.0%
1/5 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
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Endocrine disorders
Hyperthyroidism
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40.0%
2/5 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
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Musculoskeletal and connective tissue disorders
Pain
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80.0%
4/5 • Number of events 5 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial. From April 2021 (enrollment of the first patient) and until exclusion of the last patient in March 2024 (2 years, 11 months) For the individual patient, the reporting started at study enrolment and ended with study exclusion (minimum of 6 months follow-up after therapy or until study completion), up to 9.5 months Adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter, median 92 days.
Serious adverse events also includes AEs that * results in persistent or significant disability or incapacity; * leads to a congenital anomaly or birth defect; * is a significant medical event. * results in the transmission of an infectious agent * pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
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Additional Information
MD, PhD Tine Juul Monberg
National Center for Cancer Immune Therapy (CCIT-DK)
Phone: 38682983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place