Trial · NCT03228836
Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients
NCT03228836, Phase 2, Completed, Innovent Biologics (Suzhou) Co. Ltd.; results first posted 2020-12-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients. Trials, record NCT03228836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03228836
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients
- NCT number
- NCT03228836
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Conditions
- Effect of Drugs
- Interventions
- Sintilimab
- First posted
- 2017-07-25
- Last updated
- 2021-01-12
- Results first posted
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Before First PD | 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). |
| Secondary | Progression Free Survival (PFS) | 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. |
| Secondary | Duration of Response (DOR) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Before First PD | Up to ~30 months (through database cut-off date of 28-February-2020) | Percentage of Participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | Up to ~30 months (through database cut-off date of 28-February-2020) | Days | MEDIAN | |
| SECONDARY | Duration of Response (DOR) | Up to ~30 months (through database cut-off date of 28-February-2020) | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Before First PD | Sintilimab (IBI308) | 60.7 | 95% Confidence Interval 40.6 to 78.5 | Percentage of Participants | |
| Progression Free Survival (PFS) | Sintilimab (IBI308) | 104.0 | 95% Confidence Interval 45.0 to 419.0 | Days | |
| Duration of Response (DOR) | Sintilimab (IBI308) | 126.0 | 95% Confidence Interval 64.0 to 463.0 | Days |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sintilimab (IBI308) | 28 | |
| Overall Study | Treated | Sintilimab (IBI308) | 28 | |
| Overall Study | COMPLETED | Sintilimab (IBI308) | 11 | |
| Overall Study | NOT COMPLETED | Sintilimab (IBI308) | 17 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sintilimab (IBI308) | 3 | 28 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Sintilimab (IBI308) | 2 | 28 | |
| other | Myocardial ischaemia | Cardiac disorders | Sintilimab (IBI308) | 2 | 28 | |
| other | Ventricular extrasystoles | Cardiac disorders | Sintilimab (IBI308) | 3 | 28 | |
| other | Autoimmune thyroiditis | Endocrine disorders | Sintilimab (IBI308) | 2 | 28 | |
| other | Hypothyroidism | Endocrine disorders | Sintilimab (IBI308) | 9 | 28 | |
| other | Constipation | Gastrointestinal disorders | Sintilimab (IBI308) | 2 | 28 | |
| other | Gastritis | Gastrointestinal disorders | Sintilimab (IBI308) | 2 | 28 | |
| other | Mouth ulceration | Gastrointestinal disorders | Sintilimab (IBI308) | 2 | 28 | |
| other | Face oedema | General disorders | Sintilimab (IBI308) | 2 | 28 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sintilimab (IBI308) | 7 | 28 |
| Total, other adverse events | Sintilimab (IBI308) | 28 | 28 |
| Total, serious adverse events | Sintilimab (IBI308) | 7 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34702811 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03228836
GET https://conductscience.org/api/trials/v1/NCT03228836/events?page=2