Trial Outcomes & Findings for Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients (NCT NCT03228836)
NCT ID: NCT03228836
Last Updated: 2021-01-12
Results Overview
The tumor assessment is according to Lugano 2014 Criteria and then International Working Group (IWG) 2007 Criteria after 24 weeks. Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrollment to termination of trial treatment (per Lugano 2014 criteria during intial 24 weeks, per IWG 2007 criteria after 24 weeks). The primary efficacy endpoint is ORR evaluated using the 2014 Lugano Criteria before first progression disease (PD).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Up to ~30 months (through database cut-off date of 28-February-2020)
Results posted on
2021-01-12
Participant Flow
Participant milestones
| Measure |
Sintilimab (IBI308)
Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg intravenous infusion (IV) every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
Treated
|
28
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Sintilimab (IBI308)
Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg intravenous infusion (IV) every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients
Baseline characteristics by cohort
| Measure |
Sintilimab (IBI308)
n=28 Participants
Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg IV Q3W.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
40.32 years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to ~30 months (through database cut-off date of 28-February-2020)The tumor assessment is according to Lugano 2014 Criteria and then International Working Group (IWG) 2007 Criteria after 24 weeks. Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrollment to termination of trial treatment (per Lugano 2014 criteria during intial 24 weeks, per IWG 2007 criteria after 24 weeks). The primary efficacy endpoint is ORR evaluated using the 2014 Lugano Criteria before first progression disease (PD).
Outcome measures
| Measure |
Sintilimab (IBI308)
n=28 Participants
Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg IV Q3W.
|
|---|---|
|
Objective Response Rate (ORR) Before First PD
|
60.7 Percentage of Participants
Interval 40.6 to 78.5
|
SECONDARY outcome
Timeframe: Up to ~30 months (through database cut-off date of 28-February-2020)PFS was defined as the time from the first dose to the first documented progressive disease (PD) per Lugano 2014 or death due to any cause, whichever occurred first. Participates who neither progress nor die were censored at the date of their last tumor imaging evaluation. Participates who did not have any tumor imaging evaluation after baseline were censored on the date of enrollment.
Outcome measures
| Measure |
Sintilimab (IBI308)
n=28 Participants
Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg IV Q3W.
|
|---|---|
|
Progression Free Survival (PFS)
|
104.0 Days
Interval 45.0 to 419.0
|
SECONDARY outcome
Timeframe: Up to ~30 months (through database cut-off date of 28-February-2020)DOR was defined as the time from first date of response to first PD per Lugano 2014 or death. Subjects who neither progress nor die were censored at the date of their last tumor imaging evaluation.
Outcome measures
| Measure |
Sintilimab (IBI308)
n=28 Participants
Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg IV Q3W.
|
|---|---|
|
Duration of Response (DOR)
|
126.0 Days
Interval 64.0 to 463.0
|
Adverse Events
Sintilimab (IBI308)
Serious events: 7 serious events
Other events: 28 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Sintilimab (IBI308)
n=28 participants at risk
Sintilimab (IBI308) 200mg IV Q3W
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
General disorders
Disease progression
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Immune system disorders
Anaphylactic shock
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Localised infection
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
3.6%
1/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
Other adverse events
| Measure |
Sintilimab (IBI308)
n=28 participants at risk
Sintilimab (IBI308) 200mg IV Q3W
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.7%
3/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
10.7%
3/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Endocrine disorders
Hypothyroidism
|
32.1%
9/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
General disorders
Face oedema
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
General disorders
Pain
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
General disorders
Pyrexia
|
46.4%
13/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Enterovirus infection
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Gingivitis
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Pharyngitis
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Pneumonia
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Respiratory tract infection
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Sinusitis
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
7/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Urinary tract infection
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Alanine aminotransferase increased
|
10.7%
3/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Aspartate aminotransferase increased
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood albumin decreased
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
21.4%
6/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood bilirubin increased
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood glucose increased
|
25.0%
7/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
21.4%
6/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
28.6%
8/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
C-reactive protein increased
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Electrocardiogram abnormal
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Globulins decreased
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Globulins increased
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Haemoglobin decreased
|
32.1%
9/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Haemoglobin urine present
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Lipase increased
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Lymphocyte count decreased
|
60.7%
17/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Neutrophil count decreased
|
10.7%
3/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Platelet count decreased
|
21.4%
6/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Protein total decreased
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Protein urine present
|
14.3%
4/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Red blood cells urine positive
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Thyroid function test abnormal
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Thyroxine free decreased
|
17.9%
5/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Thyroxine increased
|
14.3%
4/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Tri-iodothyronine free decreased
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Urine ketone body present
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
Weight decreased
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Investigations
White blood cell count decreased
|
50.0%
14/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
2/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
4/28 • Up to ~30 months (through database cut-off date of 28-February-2020)
Safety Population: all the participants who received at least one dose of the investigational drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place