First in Human Study of IBI308 in Chinese Subjects With A... | NCT02937116 | Trialant
NCT02937116
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Status
Completed
Last Update Posted
Oct 14, 2022Actual
Enrollment
233Actual
Phase
Phase 1
Conditions
Cancer, Solid Tumor
Interventions
IBI308
IBI308\Cisplatinum\Pemetrexed
IBI308\cisplatin\gemcitabine
IBI308\oxaliplatin\capecitabine
IBI308\etoposide\cisplatin
IBI308\irinotecan\5-FU
Countries
China
Protocol Section
Identification Module
NCT ID
NCT02937116
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CIBI308A101
Secondary IDs
Not provided
Brief Title
First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
Official Title
An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors
Acronym
Not provided
Organization
Innovent Biologics (Suzhou) Co. Ltd.INDUSTRY
Status Module
Record Verification Date
Sep 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 19, 2016Actual
Primary Completion Date
Sep 30, 2020Actual
Completion Date
Sep 30, 2020Actual
First Submitted Date
Oct 8, 2016
First Submission Date that Met QC Criteria
Oct 15, 2016
First Posted Date
Oct 18, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 21, 2020
Results First Submitted that Met QC Criteria
Feb 18, 2021
Results First Posted Date
Feb 21, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 20, 2022
Last Update Posted Date
Oct 14, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Innovent Biologics (Suzhou) Co. Ltd.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety, tolerability and efficacy of IBI308 monotherapy or in combination with chemotherapy in patients with certain types of advanced solid tumors. Another purpose is to determine the pharmacokinetics, pharmacodynamics and immunogenicity of IBI308.
Detailed Description
This is a study which consists of phase 1a study (dose escalation stage) and phase 1b study (expansion stage). Phase 1a study will adopt the classical 3+3 dose escalation design, exploring safety and tolerance of 4 dose cohorts (1mg/kg, 3mg/kg, 200mg and 10mg/kg) and determining the recommended dose for phase 1b study. Phase 1b is expansion study of 8 cohorts which will evaluate anti-tumor efficacy and safety of eight IBI308 monotherapy or in combination with chemotherapy. Cohort A is IBI308 monotherapy for advanced melanoma. Cohort B is IBI308 monotherapy for advanced digestive system carcinoma or neuroendocrine neoplasm after failure or intolerance of first line standard therapy. Cohort C is IBI308 monotherapy for advanced non-small cell lung cancer (NSCLC) after failure or intolerance of first line standard therapy. Cohort D is IBI308 in combination with cisplatin and pemetrexed for treatment naïve locally advanced, recurrent or metastatic non-squamous NSCLC. Cohort E is IBI308 in combination with gemcitabine and cisplatin for treatment-naïve locally advanced, recurrent or metastatic squamous NSCLC. Cohort F is IBI308 in combination with oxaliplatin and capecitabine for treatment naïve locally advanced gastric or gastroesophageal junction adenocarcinoma. Cohort G is IBI308 in combination with etoposide and cisplatin for treatment naïve locally advanced, recurrent or metastatic high grade(G3) neuroendocrine tumor. Cohort H is IBI308 in combination with irinotecan and 5-FU for advanced high grade(G3) neuroendocrine tumor after failure of first line standard therapy. Phase 1a and 1b consist of screening period (28 days before enrollment), treatment period and follow up period (every 3 months until death or the end of study). In phase 1a, dose limiting toxicity (DLT) will be recorded for up to 28 days after the 1st dose of IBI308. Efficacy will be evaluated by RECIST v1.1. Adverse events will be monitored throughout the study. Further exploration of pharmacokinetic/pharmacodynamics and immunogenicity information will be assessed throughout the trial.
Conditions Module
Conditions
Cancer, Solid Tumor
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
233Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1a
Experimental
Participants will receive IBI308 1mg/kg, 3mg/kg or 10mg/kg intravenous every 2 weeks, or 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity.
Drug: IBI308
Drug: IBI308
Phase 1b Cohort A
Experimental
Participants will receive IBI308 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308
Drug: IBI308
Phase 1b Cohort B
Experimental
Participants will receive IBI308 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308
Drug: IBI308
Phase 1b Cohort C
Experimental
Participants will receive IBI308 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308
Drug: IBI308
Phase 1b Cohort D
Experimental
Participants will receive IBI308 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308/Cisplatinum/Pemetrexed
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IBI308
Drug
Phase 1a
Phase 1b Cohort A
Phase 1b Cohort B
Phase 1b Cohort C
IBI308\Cisplatinum\Pemetrexed
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Up to 28 days in Cycle 1
Number of All Study Participants Who Demonstrate a Tumor Response
Through out the study (up to 2 years)
Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator
ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1.
Through out the study (up to 2 years)
Secondary Outcomes
Measure
Description
Time Frame
PFS According to RECIST 1.1 as Assessed by Investigator
Through out the study (up to 2 years)
DOR According to RECIST 1.1 as Assessed by Investigator
Through out the study (up to 2 years)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
Adequate bone marrow, liver, and renal function defined as: 1) Absolute neutrophil count >= 1.5* 10^9 cells/litre (L); 2) Platelets >=100 x 10^9 cells/L; 3) Hemoglobin >= 9 gram/deciliter (g/dL); 4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 * upper limit of normal (ULN) for participants without hepatic cell cancer and hepatic metastasis, ALT and AST <= 5 * ULN for participants with hepatic cell cancer or hepatic metastasis; 5) Total bilirubin (TBIL) < 1.5 * ULN for participants without hepatic cell cancer, hepatic metastasis and confirmed/suspicious Gilbert syndrome, TBIL < 3 * ULN for participants with hepatic cell cancer, hepatic metastasis or confirmed/suspicious Gilbert syndrome; 6) Creatinine determined by serum creatinine levels <=1.5 * ULN or a calculated creatinine clearance of >= 50 mL/min/1.73 m^2; 7) urine protein -~+, 24 hour urine < 1 gram for participants with urine protein ++ or above; 8) activated partial thromboplastin time and international normalized ratio <= 1.5 * ULN; 9) thyroid stimulating hormone and free thyroxine 4 within normal range
Tumor type
Phase 1a: advanced solid tumors after failure of standard therapy
Phase 1b Cohort A: cytologically or histologically confirmed advanced melanoma
Phase 1b Cohort B: cytologically or histologically confirmed advanced malignancies of the digestive system after failure of at least 1 line of standard therapy
Phase 1b Cohort C: cytologically or histologically confirmed advanced NSCLC without known epithelial growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement after failure of 1st line standard therapy
Phase 1b Cohort D: treatment naive cytologically or histologically confirmed inoperable locally advanced (stage IIIB) or advanced (stage IV) nsNSCLC without known EGFR mutation and ALK rearrangement, participants with disease recurrence or progression within 6 months after completion of prior platinum doublet-based chemotherapy regimen as neoadjuvant or adjuvant therapy are not eligible
Phase 1b Cohort E: Cytologically or histologically confirmed, treatment naïve locally advanced, recurrent or metastatic squamous NSCLC without known EGFR mutation and ALK rearrangement. Participants with Stage IIIB NSCLC who progressed within 6 months after completion of platinum-based chemotherapy are not eligible.
Phase 1b Cohort F: Histologically confirmed locally advanced, recurrent or metastatic gastric or esophagogastric junction adenocarcinoma without known HER2 amplification.
Phase 1b Cohort G: Cytologically or histologically confirmed, treatment naïve locally advanced, recurrent or metastatic high grade(G3) neuroendocrine tumor with Ki-67>20%.
Phase 1b Cohort H: Cytologically or histologically confirmed advanced high grade(G3) neuroendocrine tumor with Ki-67>20% after failure of first line standard therapy. Participants progressed within 6 months after completion of adjuvant or neoadjuvant chemotherapy are eligible.
At least 1 measurable site of disease per RECIST v1.1
Exclusion Criteria:
Prior treatment of any antibody of PD-1 or PD-L1
Prior treatment of ipilimumab, unless all the following requirements are met:
Full resolution of ipilimumab related adverse effects (including immune related adverse effects) and no treatment for these adverse events (AEs) for at least 4 weeks prior to the time of enrollment
Minimum of 12 weeks from the first dose of ipilimumab and >6 weeks from the last dose
No history of severe immune related adverse effects from ipilimumab (CTCAE Grade 4; CTCAE Grade 3 requiring treatment >4 weeks)
Unequivocal PD following a dose of ipilimumab
HIV infection
Active HBV or HCV infection
Uncontrolled complication including but not limited to :
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias or congestive heart failure
History of stroke, myocardial infarction or intracranial hemorrhage within 6 months prior to the enrolment
History or risk of autoimmune disease
Known interstitial lung disease
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The fifth medical center of the PLA general hospital
Jiang H, Zheng Y, Qian J, Mao C, Xu X, Li N, Xiao C, Wang H, Teng L, Zhou H, Wang S, Zhu D, Peng B, Shen L, Xu N. Safety and efficacy of sintilimab combined with oxaliplatin/capecitabine as first-line treatment in patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in a phase Ib clinical trial. BMC Cancer. 2020 Aug 14;20(1):760. doi: 10.1186/s12885-020-07251-z.
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
FG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 31, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: IBI308\Cisplatinum\Pemetrexed
Phase 1b Cohort E
Experimental
Participants will receive IBI308 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308\gemcitabine\cisplatin
Drug: IBI308\cisplatin\gemcitabine
Phase 1b Cohort F
Experimental
Participants will receive IBI308 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308\oxaliplatin\capecitabine
Drug: IBI308\oxaliplatin\capecitabine
Phase 1b Cohort G
Experimental
Participants will receive IBI308 200mg in combination with cisplatin 75mg/m2 intravenously and etoposide 100mg/m2 intravenously day 1 to 3 of every 3 weeks for upto 6 cycles. Those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308\etoposide\cisplatin
Drug: IBI308\etoposide\cisplatin
Phase 1b Cohort H
Experimental
Participants will receive IBI308 200mg in combination with irinotecan 125mg/m2 intravenously day 1and 8 and 5-FU 1000mg/m2 intravenously day 1 to 3 of every 3 weeks for upto 6 cycles.Those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Drug: IBI308\irinotecan\5-FU
Drug: IBI308\irinotecan\5-FU
Drug
Phase 1b Cohort D
IBI308\cisplatin\gemcitabine
Drug
Phase 1b Cohort E
IBI308\oxaliplatin\capecitabine
Drug
Phase 1b Cohort F
IBI308\etoposide\cisplatin
Drug
Phase 1b Cohort G
IBI308\irinotecan\5-FU
Drug
Phase 1b Cohort H
TTR According to RECIST 1.1 as Assessed by Investigator
Through out the study (up to 2 years)
OS for Participants
Through out the study
Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)
Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Volume of Distribution of IBI308 in Plasma After Single Dose Administration
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Clearance of IBI308 in Plasma After Single Dose Administration
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Result
Jiang H, Zheng Y, Qian J, Mao C, Xu X, Li N, Xiao C, Wang H, Teng L, Zhou H, Wang S, Zhu D, Sun T, Yu Y, Guo W, Xu N. Efficacy and safety of sintilimab in combination with chemotherapy in previously untreated advanced or metastatic nonsquamous or squamous NSCLC: two cohorts of an open-label, phase 1b study. Cancer Immunol Immunother. 2021 Mar;70(3):857-868. doi: 10.1007/s00262-020-02738-x. Epub 2020 Oct 17.
Wei J, Lu X, Liu Q, Fu Y, Liu S, Li L, Liu F, Fan X, Yang J, Yang Y, Zhao Y, Guan W, Liu B. Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial. Cancer Manag Res. 2022 Jun 17;14:2007-2015. doi: 10.2147/CMAR.S355687. eCollection 2022.
Jia R, Li Y, Xu N, Jiang HP, Zhao CH, Liu RR, Shi Y, Zhang YY, Wang SY, Zhou H, Xu JM. Sintilimab in Patients with Previously Treated Metastatic Neuroendocrine Neoplasms. Oncologist. 2022 Aug 5;27(8):e625-e632. doi: 10.1093/oncolo/oyac097.
Jiang H, Li N, Wang H, Chen Z, Zheng Y, Qian J, Mao C, Xu X, Xiao C, Zhang X, Zhou H, Wang S, Chen W, Yin X, Sun J, Peng B, Teng L, Xu N. Assessment of TMB, PD-L1, and lymphocyte to monocyte ratio as predictive potential in a phase Ib study of sintilimab in patients with advanced solid tumors. Am J Cancer Res. 2021 Sep 15;11(9):4259-4276. eCollection 2021.
Zhang J, Wu L, Liu J, Lin M. A metastatic intrahepatic cholangiocarcinoma treated with programmed cell death 1 inhibitor: a case report and literature review. Immunotherapy. 2020 Jun;12(8):555-561. doi: 10.2217/imt-2019-0100. Epub 2020 May 6.
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
FG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
FG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
FG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
FG005
Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
FG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG00422 subjects
FG00587 subjects
FG00637 subjects
FG00721 subjects
FG00820 subjects
FG00920 subjects
FG0107 subjects
FG0117 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG00422 subjects
FG00587 subjects
FG00637 subjects
FG00721 subjects
FG00820 subjects
FG00920 subjects
FG0107 subjects
FG0117 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
BG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
BG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
BG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
BG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
BG005
Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
BG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0033
BG00422
BG00587
BG00637
BG00721
BG00820
BG00920
BG0107
BG0117
BG012233
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00044.33± 17.010
BG00146± 15.524
BG00248± 6.557
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
China
Title
Measurements
BG0003
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
All participants in Parts A1 to A4 who received ≥1 dose of study treatment and either 1) had a DLT in Cycle 1 or 2) received ≥90% of the prescribed dose of Sintilimab in Cycle 1 and completed all safety evaluations ≥28 days after the first administration of Sintilimab without experiencing DLT. Per protocol, cohort A to H were not analyzed.
Posted
Number
Participants
Up to 28 days in Cycle 1
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of All Study Participants Who Demonstrate a Tumor Response
Posted
Number
Participants
Through out the study (up to 2 years)
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Primary
Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator
ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1.
Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.
Posted
Number
95% Confidence Interval
percentage of participants
Through out the study (up to 2 years)
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
Secondary
PFS According to RECIST 1.1 as Assessed by Investigator
Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.
Posted
Median
95% Confidence Interval
Days
Through out the study (up to 2 years)
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Secondary
DOR According to RECIST 1.1 as Assessed by Investigator
Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.
Posted
Median
95% Confidence Interval
Days
Through out the study (up to 2 years)
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Secondary
TTR According to RECIST 1.1 as Assessed by Investigator
Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.
Posted
Median
95% Confidence Interval
Days
Through out the study (up to 2 years)
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Secondary
OS for Participants
Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.
Posted
Median
95% Confidence Interval
Days
Through out the study
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
OG004
Secondary
Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)
All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC 0-t data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis..
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/ml
Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
Secondary
Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants
All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available Cmax data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/ml
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Secondary
Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants
All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available Tmax data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.
Posted
Median
Full Range
hours
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Secondary
The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration
All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available T1/2 data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Secondary
Volume of Distribution of IBI308 in Plasma After Single Dose Administration
All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available volume of distribution data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
L
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Secondary
Clearance of IBI308 in Plasma After Single Dose Administration
All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available clearance data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ml/h
Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
ID
Title
Description
OG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
OG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
Time Frame
Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
Description
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
0
3
1
3
3
3
EG001
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
2
3
2
3
3
3
EG002
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
3
3
1
3
3
3
EG003
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
1
3
1
3
3
3
EG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
12
22
0
22
18
22
EG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
57
87
18
87
82
87
EG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
0
7
1
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected22 at risk
EG0053 affected87 at risk
EG0060 affected37 at risk
EG0070 affected21 at risk
EG0080 affected20 at risk
EG0090 affected20 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
Intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Functional gastrointestinal disorder
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gallbladder pain
Hepatobiliary disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Jaundice
Hepatobiliary disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Death
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Biliary tract infection
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Lung infection
Infections and infestations
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Soft tissue infection
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyopneumothorax
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tracheal haemorrhage
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Amylase increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Renal hydrocele
Renal and urinary disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0032 affected3 at risk
EG0042 affected22 at risk
EG00537 affected87 at risk
EG00610 affected37 at risk
EG0079 affected21 at risk
EG00817 affected20 at risk
EG00912 affected20 at risk
EG0106 affected7 at risk
EG0114 affected7 at risk
Coagulopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arrhythmia
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bundle branch block right
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Goitre
Endocrine disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thyroid mass
Endocrine disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thyroiditis
Endocrine disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Conjunctival hyperaemia
Eye disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eyelid oedema
Eye disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Xerophthalmia
Eye disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastric dilatation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Loose tooth
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retching
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Subileus
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Chest discomfort
General disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Face oedema
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal infection
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sebaceous gland infection
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Soft tissue infection
Infections and infestations
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tonsillitis
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0003 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Amylase increased
Investigations
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Bilirubin conjugated increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood albumin decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Blood bilirubin unconjugated increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood cholesterol increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood potassium decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood potassium increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood pressure increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood triglycerides increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood urea increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood uric acid increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
C-reactive protein increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Creatinine renal clearance increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram abnormal
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram low voltage
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Glucose urine present
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Granulocyte count decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Heart rate increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mean cell haemoglobin concentration decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Occult blood positive
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Procalcitonin increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Protein urine present
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Red blood cell count decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Red blood cells urine positive
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thyroid function test abnormal
Investigations
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Thyroxine decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thyroxine free decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thyroxine free increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thyroxine increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tri-iodothyronine decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tri-iodothyronine free decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tri-iodothyronine free increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urine ketone body present
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Weight increased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count increased
Investigations
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cells urine positive
Investigations
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abnormal loss of weight
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0003 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG00422
OG00587
OG00637
OG00721
OG00820
OG00920
OG0107
OG0117
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0041
OG00513
OG0065
OG00713
OG00811
OG00917
OG0103
OG0111
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG00422
OG00587
OG00637
OG00721
OG00820
OG00920
OG0107
OG0117
Title
Denominators
Categories
Title
Measurements
OG0044.5(0.1 to 22.8)
OG00514.9(8.2 to 24.2)
OG00613.5(4.5 to 28.8)
OG00761.9(38.4 to 81.9)
OG00855.0(31.5 to 76.9)
OG00985.0(62.1 to 96.8)
OG01042.9(9.9 to 81.6)
OG01114.3(0.4 to 57.9)
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG00422
OG00587
OG00637
OG00721
OG00820
OG00920
OG0107
OG0117
Title
Denominators
Categories
Title
Measurements
OG00462.0(59.0 to 125.0)
OG00566.0(64.0 to 95.0)
OG00684.0(60.0 to 187.0)
OG007377.0(92.0 to NA)PFS range upper limit of 95% CI not reached
OG008194.0(160.0 to 239.0)
OG009230.0(189.0 to 287.0)
OG010NA(NA to NA)Median PFS and PFS range lower and upper limit of 95% CI not reached (no disease progression by last progression assessment)
OG011NA(68.0 to NA)Median PFS and PFS range upper limit of 95% CI not reached
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG00422
OG00587
OG00637
OG00721
OG00820
OG00920
OG0107
OG0117
Title
Denominators
Categories
Title
Measurements
OG004NA(NA to NA)Median DOR and DOR lower and upper limit not reached
OG005NA(86.0 to NA)Median DOR and DOR upper limit not reached (no progressive disease by time of last disease assessment)
OG006368.0(190.0 to NA)DOR upper limit not reached
OG007NA(NA to NA)Median DOR and DOR lower and upper limit not reached
OG008170.5(58.0 to NA)DOR upper limit not reached
OG009181.0(146.0 to 221.0)
OG010NA(NA to NA)Median DOR and DOR lower and upper limit of 95% CI not reached
OG011NA(NA to NA)Median DOR and DOR lower and upper limit of 95% CI not reached
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG00422
OG00587
OG00637
OG00721
OG00820
OG00920
OG0107
OG0117
Title
Denominators
Categories
Title
Measurements
OG00463.0(NA to NA)TTR louwer and upper limit not reached
OG00564.0(61.0 to 70.0)
OG00663.0(60.0 to 189.0)
OG00763.0(62.0 to 120.0)
OG00862.0(58.0 to 68.0)
OG00963.0(62.0 to 65.0)
OG01062.0(62.0 to 63.0)
OG01162.0(62.0 to 62.0)
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG00422
OG00587
OG00637
OG00721
OG00820
OG00920
OG0107
OG0117
Title
Denominators
Categories
Title
Measurements
OG004518.0(349.0 to NA)OS range upper limit not reached
OG005342.0(218.0 to 441.0)
OG006431.0(196.0 to 562.0)
OG007566.0(158.0 to NA)OS range upper limit not reached
OG008461.0(308.0 to NA)OS range upper limit not reached
OG009NA(287.0 to NA)Median OS and OS range upper limit not reached
OG010NA(NA to NA)Median OS and OS range lower and upper limit of 95% CI not reached (no death by last assessment)
OG011NA(NA to NA)Median OS and OS range lower and upper limit of 95% CI not reached (no death by last assessment)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG0004800± 8.2
OG00112300± 35.2
OG00239800± 14.5
OG00310800± 49.3
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG00021.9± 11.3
OG00169.7± 12.2
OG002220± 13.4
OG00354.6± 50.5
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG0001.05(1.05 to 1.08)
OG0012.07(2.07 to 2.08)
OG0022.27(1.10 to 2.33)
OG0031.93(1.08 to 2.13)
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG00017± 7.3
OG00112.7± 44.6
OG00212.5± 26.4
OG00316.1± 32.6
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG0005.02± 24.0
OG0015.14± 18.7
OG0025.95± 10.5
OG0037.2± 45.0
OG004
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG005
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OG006
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.