Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Age... | NCT02795429 | Trialant
NCT02795429
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 3, 2023Actual
Enrollment
89Actual
Phase
Phase 1Phase 2
Conditions
Advanced Hepatocellular Carcinoma
Interventions
Spartalizumab
Capmatinib
Countries
Canada
China
France
Germany
Hong Kong
Italy
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02795429
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CINC280X2108
Secondary IDs
ID
Type
Description
Link
2015-005417-76
EudraCT Number
Brief Title
Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC
Official Title
A Phase Ib/II, Open-label, Multi-center Study of INC280 in Combination With PDR001 or PDR001 Single Agent in Advanced Hepatocellular Carcinoma.
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2023
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
Jun 15, 2016Actual
Primary Completion Date
Jun 1, 2021Actual
Completion Date
Jun 24, 2021Actual
First Submitted Date
May 17, 2016
First Submission Date that Met QC Criteria
Jun 9, 2016
First Posted Date
Jun 10, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
May 26, 2022
Results First Submitted that Met QC Criteria
Jun 7, 2023
Results First Posted Date
Jul 3, 2023Actual
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
Jun 7, 2023
Last Update Posted Date
Jul 3, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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 of capmatinib (INC280) and spartalizumab (PDR001) was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of spartalizumab administered intravenously (i.v.) as a single agent or in combination with capmatinib administered orally in adult patients with advanced hepatocellular carcinoma (HCC).
Detailed Description
This was a Phase Ib/II, open label, multicenter study starting with a Phase Ib dose escalation part followed by a randomized Phase II part in patients with advanced hepatocellular carcinoma. Capmatinib was administered orally twice daily (BID) and spartalizumab was administered i.v. every 3 weeks (Q3W) until the occurrence of unacceptable toxicity, progressive disease as per irRC and/or treatment was discontinued at the discretion of the Investigator or the participant. A complete cycle of treatment was defined as 21 days.
During the Phase Ib dose escalation part of the study, participants were treated with capmatinib in combination with a fixed dose of spartalizumab until the maximum tolerated dose (MTD) was reached or the recommended phase 2 dose (RP2D) was established. The capmatinib dose was increased and the spartalizumab dose remained constant.
Once the MTD and/or RP2D were declared for capmatinib in combination with spartalizumab, additional participants were enrolled in the Phase II part in order to assess the anti-tumor activity of capmatinib in combination with spartalizumab and spartalizumab single agent. Participants were randomly assigned, in a 1:1 ratio, to treatment with either capmatinib in combination with spartalizumab or spartalizumab single agent.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Drug: Spartalizumab
Drug: Capmatinib
Phase II: Spartalizumab 300 mg Q3W
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Spartalizumab
Drug
Spartalizumab administered via intravenous (i.v.) infusion once every 3 weeks (Q3W)
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.
The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
From first dose of study medication up to 30 days after last dose, with a maximum duration of 3.3 years
Phase Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) During the First 2 Cycles of Treatment
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 2 cycles of treatment with capmatinib in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. The duration of one treatment cycle is 21 days.
42 days
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab
Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab.
No dose modifications (i.e. dose reduction) were allowed for spartalizumab.
From first dose of study medication up to last dose, with a maximum duration of 3.2 years
Phase Ib: Dose Intensity of Capmatinib
Dose intensity of capmatinib was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.
Secondary Outcomes
Measure
Description
Time Frame
Phase Ib and Phase II: Best Overall Response (BOR) Per RECIST v1.1
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1.
For RECIST v1.1, R=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression).
The number of participants in each response category is reported in the table.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented locally advanced recurrent or metastatic HCC or for patients with cirrhosis according to the American Association for the Study of Liver Diseases (AASLD) and Asian Pacific Association for the study of the liver (APASL) criteria. Current cirrhotic status of Child Pugh Class A (5-6 points), with no encephalopathy and/or clinically significant ascites (defined as requiring the use of diuretics or paracentesis treatment).
Patients must have received prior systemic sorafenib treatment for HCC with documented progression during or after discontinuation of sorafenib treatment (for France only: patients must have received at least 8 weeks of prior sorafenib treatment), or are intolerant to sorafenib (defined as documented Grade 3 or 4 adverse events that led to sorafenib discontinuation),.
ECOG Performance Status ≤ 1.
Willing and able to swallow and retain oral medication.
Exclusion Criteria:
Use of any live vaccines within 4 weeks of initiation of study treatment.
History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).
Clinically significant pleural effusion that either required pleurocentesis or is associated with shortness of breath.
Active autoimmune disease or a documented history of autoimmune disease.
Patient having out of range laboratory values defined as:
Total bilirubin > 2 mg/dL, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Alanine aminotransferase (ALT) > 5 x ULN
Aspartate aminotransferase (AST) > 5 x ULN
Coagulation: Prothrombin Time (PT) > 4 seconds more than the ULN or International Normalized Ratio (INR) > 1.7
Absolute neutrophil count (ANC) < 1.5 x 109/L
Platelet count < 75 x 109/L
Hemoglobin < 9 g/dL
Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 45 mL/min
Asymptomatic serum amylase grade > 2 (1.5-2.0 x ULN). Patients with grade 1 or grade 2 serum amylase at the beginning of the study must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.)
Serum lipase > ULN
Potassium, Magnesium, Phosphorus, total Calcium (corrected for serum albumin) outside of normal limits (patients may be enrolled if corrected to within normal limits with supplements during screening)
Santoro A, Assenat E, Yau T, Delord JP, Maur M, Knox J, Cattan S, Lee KH, Del Conte G, Springfeld C, Leo E, Xyrafas A, Fairchild L, Mardjuadi F, Chan SL. A phase Ib/II trial of capmatinib plus spartalizumab vs. spartalizumab alone in patients with pretreated hepatocellular carcinoma. JHEP Rep. 2024 Jan 28;6(4):101021. doi: 10.1016/j.jhepr.2024.101021. eCollection 2024 Apr.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 21 days prior to the first dose of study medication. After screening, the treatment period started on Cycle 1 Day 1.
Recruitment Details
Participants took part in 18 investigative sites in 8 countries.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
From first dose of study medication up to last dose, with a maximum duration of 3.2 years
Phase Ib: Dose Intensity of Spartalizumab
Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in weeks and then multiplied by 3 weeks (3W).
From first dose of study medication up to last dose, with a maximum duration of 3.2 years
Phase II: Overall Response Rate (ORR) Per RECIST v1.1
Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).
For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
From start of treatment until end of treatment, assessed up to 2.2 years
From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Best Overall Response (BOR) Per irRC
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per Immune-related Response Criteria (irRC).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters; irPD= At least a 20% increase in the sum of diameters of all measured target lesions including new measurable lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; irSD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for irPD).
From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib: Overall Response Rate (ORR) Per RECIST v1.1
Tumor response was based on local investigator assessment as per RECIST v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).
For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
From start of treatment until end of treatment, assessed up to 3.2 years
Phase Ib and Phase II: Overall Response Rate (ORR) Per irRC
Tumor response was based on local investigator assessment as per irRC. ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters.
From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Duration of Response (DOR) Per RECIST v1.1
DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment of overall lesion response according to RECIST v1.1. DOR is defined as the time from the date of first documented response (confirmed CR or confirmed PR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any.
According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm.
From first documented response to first documented disease progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Duration of Response (DOR) Per irRC
DOR only applies to patients for whom best overall response is immune-related complete response (irCR) or immune-related partial response (irPR) based on local investigator assessment of overall lesion response according to irRC. DOR is defined as the time from the date of first documented response (confirmed irCR or confirmed irPR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any.
According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed irCR or irPR in each treatment group/arm.
From first documented response to first documented disease progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Time to Response (TTR) Per RECIST v1.1
TTR is defined as the time from the date of start of treatment to the date of first documented response (CR or PR, which must be confirmed subsequently) for patients who achieved a confirmed CR or PR. Tumor response was based on local investigator assessment per RECIST v1.1.
Patients who did not achieve a confirmed CR or PR were censored at the maximum follow-up time for patients who had a Progression-Free Survival (PFS) event (i.e. either progressed or died due to any cause), or at the date of last adequate tumor assessment before the start of a new anticancer therapy (if any) otherwise.
According to the statistical analysis plan (SAP), summary estimates of TTR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm.
From start of treatment until first documented response, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Time to Response (TTR) Per irRC
TTR is defined as the time from the date of start of treatment to the date of first documented response (irCR or irPR, which must be confirmed subsequently) for patients who achieved a confirmed irCR or irPR. Tumor response was based on local investigator assessment per irRC.
Patients who did not achieve a confirmed irCR or irPR were censored at the maximum follow-up time for patients who had a Progression-Free Survival (PFS) event (i.e. either progressed or died due to any cause), or at the date of last adequate tumor assessment before the start of a new anticancer therapy (if any) otherwise.
According to the statistical analysis plan (SAP), summary estimates of TTR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed irCR or irPR in each treatment group/arm.
From start of treatment until first documented response, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Progression-Free Survival (PFS) Per RECIST v1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression per RECIST v1.1 or death due to any cause. If a patient did not experience an event or started a new anticancer therapy, PFS was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per RECIST v1.1.
PFS was estimated using the Kaplan-Meier Method.
From start of treatment until first documented progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Progression-Free Survival (PFS) Per irRC
PFS is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression per irRC or death due to any cause. If a patient did not experience an event or started a new anticancer therapy, PFS was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per irRC.
PFS was estimated using the Kaplan-Meier Method.
From start of treatment until first documented progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Time to Progression (TTP) Per RECIST v1.1
TTP is defined as the time from the date of start of treatment to the date of the first documented progression per RECIST v1.1 or death due to underlying cancer. If a patient did not experience an event or started a new anticancer therapy, TTP was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per RECIST v1.1.
TTP was estimated using the Kaplan-Meier Method.
From start of treatment until first documented progression or death due to underlying cancer, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Time to Progression (TTP) Per irRC
TTP is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression per irRC or death due to underlying cancer. If a patient did not experience an event or started a new anticancer therapy, TTP was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per irRC.
From start of treatment until first documented progression or death due to underlying cancer, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Phase Ib and Phase II: Overall Survival (OS)
OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, OS time was censored at the date of last contact.
OS was estimated using the Kaplan-Meier Method.
From start of treatment until death due to any cause, assessed up to 3.6 years in Phase Ib and up to 2.9 years in Phase II
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.
The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
From first dose of study medication up to 30 days after last dose, with a maximum duration of 2.3 years
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab
Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab.
No dose modifications (i.e. dose reduction) were allowed for spartalizumab.
From first dose of study medication up to last dose, with a maximum duration of 2.2 years
Phase II: Dose Intensity of Capmatinib
Dose intensity of capmatinib was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.
From first dose of study medication up to last dose, with a maximum duration of 2.2 years
Phase II: Dose Intensity of Spartalizumab
Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in weeks and then multiplied by 3 weeks (3W).
From first dose of study medication up to last dose, with a maximum duration of 2.2 years
Phase Ib: Maximum Observed Plasma Concentration (Cmax) of Capmatinib
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.
pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.
Phase Ib: Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.
pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.
Phase Ib: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.
Phase II: Pre-dose Plasma Concentration of Capmatinib
Capmatinib plasma concentration was assessed in samples taken at pre-dose. Pre-dose samples were collected before the next dose administration.
Pre-dose of capmatinib on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1. The duration of one cycle was 21 days.
Phase Ib and Phase II: Maximum Observed Serum Concentration (Cmax) of Spartalizumab
Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.
Phase Ib and Phase II: Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab
Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.
Phase Ib and Phase II: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab
Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.
Phase Ib and Phase II: Percent Marker Area for CD8 Expression in Tumor Samples
The expression of CD8 was measured in tumor samples by immunohistochemical methods. This record summarizes the percent marker area for CD8 expression in tumor samples.
Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 115 days).
Phase Ib and Phase II: PD-L1 Percent Positive Tumor
The expression of programmed cell death-ligand 1 (PD-L1) was measured in tumor samples by immunohistochemical methods. This record summarizes the PD-L1 positivity percentage in tumor samples.
Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 115 days).
Montreal
Quebec
H3T 1E2
Canada
Novartis Investigative Site
Guangzhou
Guangdong
510515
China
Novartis Investigative Site
Shanghai
Shanghai Municipality
200032
China
Novartis Investigative Site
Montpellier
Herault
34059
France
Novartis Investigative Site
Lille
59037
France
Novartis Investigative Site
Toulouse
31059
France
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Würzburg
97080
Germany
Novartis Investigative Site
Hong Kong
Hong Kong
Novartis Investigative Site
Milan
MI
20132
Italy
Novartis Investigative Site
Rozzano
MI
20089
Italy
Novartis Investigative Site
Modena
MO
41124
Italy
Novartis Investigative Site
Seoul
03080
South Korea
Novartis Investigative Site
Seoul
03722
South Korea
Novartis Investigative Site
Tainan
70403
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
FG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
BG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG00110
BG00211
BG00332
BG00430
BG00589
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
BG00068.5± 7.42
BG00163.2± 10.24
BG00264.6± 8.99
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
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
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.
The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
All patients who had received at least one dose of spartalizumab or capmatinib in the Phase Ib part
Posted
Count of Participants
Participants
From first dose of study medication up to 30 days after last dose, with a maximum duration of 3.3 years
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Units
Counts
Participants
OG0006
OG00110
OG00211
Title
Denominators
Categories
AEs
Title
Measurements
OG0006
OG00110
OG00210
Treatment-related AEs
Primary
Phase Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) During the First 2 Cycles of Treatment
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 2 cycles of treatment with capmatinib in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. The duration of one treatment cycle is 21 days.
Patients in Phase Ib who either met the minimum exposure criterion and had sufficient safety evaluations, or had experienced a DLT during Cycles 1 and 2. A patient was considered to have met the minimum exposure criterion if received at least 2 doses of spartalizumab and 28 days of capmatinib during Cycles 1 and 2. Patients who did not experience a DLT during the first 2 cycles were considered to have sufficient safety evaluations if they had been observed for at least 42 days after first dose.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab
Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab.
No dose modifications (i.e. dose reduction) were allowed for spartalizumab.
All patients who had received at least one dose of spartalizumab or capmatinib in the Phase Ib part
Posted
Count of Participants
Participants
From first dose of study medication up to last dose, with a maximum duration of 3.2 years
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Primary
Phase Ib: Dose Intensity of Spartalizumab
Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in weeks and then multiplied by 3 weeks (3W).
All patients who had received at least one dose of spartalizumab or capmatinib in the Phase Ib part
Posted
Median
Full Range
mg/3W
From first dose of study medication up to last dose, with a maximum duration of 3.2 years
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Primary
Phase II: Overall Response Rate (ORR) Per RECIST v1.1
Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).
For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
All patients to whom study treatment was assigned by randomization in the Phase II part
Posted
Number
95% Confidence Interval
percentage of participants
From start of treatment until end of treatment, assessed up to 2.2 years
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG001
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Secondary
Phase Ib and Phase II: Best Overall Response (BOR) Per RECIST v1.1
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1.
For RECIST v1.1, R=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression).
The number of participants in each response category is reported in the table.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Count of Participants
Participants
From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Best Overall Response (BOR) Per irRC
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per Immune-related Response Criteria (irRC).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters; irPD= At least a 20% increase in the sum of diameters of all measured target lesions including new measurable lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; irSD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for irPD).
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Count of Participants
Participants
From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib: Overall Response Rate (ORR) Per RECIST v1.1
Tumor response was based on local investigator assessment as per RECIST v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).
For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
All patients who had received at least one dose of spartalizumab or capmatinib capmatinib in the Phase Ib part
Posted
Number
95% Confidence Interval
percentage of participants
From start of treatment until end of treatment, assessed up to 3.2 years
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Overall Response Rate (ORR) Per irRC
Tumor response was based on local investigator assessment as per irRC. ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Number
95% Confidence Interval
percentage of participants
From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Duration of Response (DOR) Per RECIST v1.1
DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment of overall lesion response according to RECIST v1.1. DOR is defined as the time from the date of first documented response (confirmed CR or confirmed PR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any.
According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm.
All participants in Phase Ib and II for whom best overall response is complete response (CR) or partial response (PR) as per RECIST v1.1 based on local investigator assessment.
Posted
Median
95% Confidence Interval
months
From first documented response to first documented disease progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Phase Ib and Phase II: Duration of Response (DOR) Per irRC
DOR only applies to patients for whom best overall response is immune-related complete response (irCR) or immune-related partial response (irPR) based on local investigator assessment of overall lesion response according to irRC. DOR is defined as the time from the date of first documented response (confirmed irCR or confirmed irPR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any.
According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed irCR or irPR in each treatment group/arm.
All participants in Phase Ib and II for whom best overall response is immune-related complete response (irCR) or immune-related partial response (irPR) as per irRC based on local investigator assessment.
Posted
Median
95% Confidence Interval
months
From first documented response to first documented disease progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
OG001
Secondary
Phase Ib and Phase II: Time to Response (TTR) Per RECIST v1.1
TTR is defined as the time from the date of start of treatment to the date of first documented response (CR or PR, which must be confirmed subsequently) for patients who achieved a confirmed CR or PR. Tumor response was based on local investigator assessment per RECIST v1.1.
Patients who did not achieve a confirmed CR or PR were censored at the maximum follow-up time for patients who had a Progression-Free Survival (PFS) event (i.e. either progressed or died due to any cause), or at the date of last adequate tumor assessment before the start of a new anticancer therapy (if any) otherwise.
According to the statistical analysis plan (SAP), summary estimates of TTR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Median
95% Confidence Interval
months
From start of treatment until first documented response, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Phase Ib and Phase II: Time to Response (TTR) Per irRC
TTR is defined as the time from the date of start of treatment to the date of first documented response (irCR or irPR, which must be confirmed subsequently) for patients who achieved a confirmed irCR or irPR. Tumor response was based on local investigator assessment per irRC.
Patients who did not achieve a confirmed irCR or irPR were censored at the maximum follow-up time for patients who had a Progression-Free Survival (PFS) event (i.e. either progressed or died due to any cause), or at the date of last adequate tumor assessment before the start of a new anticancer therapy (if any) otherwise.
According to the statistical analysis plan (SAP), summary estimates of TTR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed irCR or irPR in each treatment group/arm.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Median
95% Confidence Interval
months
From start of treatment until first documented response, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Phase Ib and Phase II: Progression-Free Survival (PFS) Per RECIST v1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression per RECIST v1.1 or death due to any cause. If a patient did not experience an event or started a new anticancer therapy, PFS was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per RECIST v1.1.
PFS was estimated using the Kaplan-Meier Method.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patientss to whom study treatment was assigned by randomization in the Phase II part.
Posted
Median
95% Confidence Interval
months
From start of treatment until first documented progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Progression-Free Survival (PFS) Per irRC
PFS is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression per irRC or death due to any cause. If a patient did not experience an event or started a new anticancer therapy, PFS was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per irRC.
PFS was estimated using the Kaplan-Meier Method.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Median
95% Confidence Interval
months
From start of treatment until first documented progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Time to Progression (TTP) Per RECIST v1.1
TTP is defined as the time from the date of start of treatment to the date of the first documented progression per RECIST v1.1 or death due to underlying cancer. If a patient did not experience an event or started a new anticancer therapy, TTP was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per RECIST v1.1.
TTP was estimated using the Kaplan-Meier Method.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Median
95% Confidence Interval
months
From start of treatment until first documented progression or death due to underlying cancer, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Time to Progression (TTP) Per irRC
TTP is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression per irRC or death due to underlying cancer. If a patient did not experience an event or started a new anticancer therapy, TTP was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per irRC.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Median
95% Confidence Interval
months
From start of treatment until first documented progression or death due to underlying cancer, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Overall Survival (OS)
OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, OS time was censored at the date of last contact.
OS was estimated using the Kaplan-Meier Method.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Median
95% Confidence Interval
months
From start of treatment until death due to any cause, assessed up to 3.6 years in Phase Ib and up to 2.9 years in Phase II
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.
The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
All patients to whom study treatment was assigned by randomization in the Phase II part
Posted
Count of Participants
Participants
From first dose of study medication up to 30 days after last dose, with a maximum duration of 2.3 years
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG001
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Secondary
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab
Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab.
No dose modifications (i.e. dose reduction) were allowed for spartalizumab.
All patients to whom study treatment was assigned by randomization in the Phase II part
Posted
Count of Participants
Participants
From first dose of study medication up to last dose, with a maximum duration of 2.2 years
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG001
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
Secondary
Phase II: Dose Intensity of Capmatinib
Dose intensity of capmatinib was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.
All patients assigned by randomization to capmatinib in combination with spartalizumab in the Phase II part
Posted
Median
Full Range
mg/day
From first dose of study medication up to last dose, with a maximum duration of 2.2 years
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG001
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG000
Secondary
Phase II: Dose Intensity of Spartalizumab
Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in weeks and then multiplied by 3 weeks (3W).
All patients to whom study treatment was assigned by randomization in the Phase II part
Posted
Median
Full Range
mg/3W
From first dose of study medication up to last dose, with a maximum duration of 2.2 years
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG001
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG000
Secondary
Phase Ib: Maximum Observed Plasma Concentration (Cmax) of Capmatinib
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.
All patients in Phase Ib who provided an evaluable capmatinib PK profile on C2D1. Capmatinib PK profile was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after dosing and patient provided at least 1 primary PK parameter.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib: Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.
All patients in Phase Ib who provided an evaluable capmatinib PK profile on C2D1. Capmatinib PK profile was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after dosing and patient provided at least 1 primary PK parameter.
Posted
Median
Full Range
hours
pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
All patients in Phase Ib who provided an evaluable capmatinib PK profile on C2D1. Capmatinib PK profile was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after dosing and patient provided at least 1 primary PK parameter.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*ng/mL
pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase II: Pre-dose Plasma Concentration of Capmatinib
Capmatinib plasma concentration was assessed in samples taken at pre-dose. Pre-dose samples were collected before the next dose administration.
All patients in Phase II part who provided an evaluable capmatinib concentration at the specified timepoints. Capmatinib concentration was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after the dosing prior to sampling.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose of capmatinib on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1. The duration of one cycle was 21 days.
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG001
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Secondary
Phase Ib and Phase II: Maximum Observed Serum Concentration (Cmax) of Spartalizumab
Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
All patients in Phase Ib and Phase II who provided an evaluable PK profile of spartalizumab on Cycle 1 and Cycle 3. The spartalizumab PK profile was considered evaluable if all the following conditions were satisfied: patient received the planned treatment with spartalizumab and patient provided at least 1 primary PK parameter.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab
Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
All patients in Phase Ib and Phase II who provided an evaluable PK profile of spartalizumab on Cycle 1 Day 1 and Cycle 3 Day 1. The spartalizumab PK profile was considered evaluable if all the following conditions were satisfied: patient received the planned treatment with spartalizumab and patient provided at least 1 primary PK parameter.
Posted
Median
Full Range
hours
pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab
Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
All patients in Phase Ib and Phase II who provided an evaluable PK profile of spartalizumab on Cycle 1 Day 1 and Cycle 3 Day 1. The spartalizumab PK profile was considered evaluable if all the following conditions were satisfied: patient received the planned treatment with spartalizumab and patient provided at least 1 primary PK parameter.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*µg/mL
pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Secondary
Phase Ib and Phase II: Percent Marker Area for CD8 Expression in Tumor Samples
The expression of CD8 was measured in tumor samples by immunohistochemical methods. This record summarizes the percent marker area for CD8 expression in tumor samples.
All patients who received at least one dose of study treatment in the Phase Ib part and had a valid assessment for the outcome measure, and all patients to whom study treatment was assigned by randomization in the Phase II part and had a valid assessment for the outcome measure.
Posted
Median
Full Range
CD8 percent marker area
Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 115 days).
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Phase Ib and Phase II: PD-L1 Percent Positive Tumor
The expression of programmed cell death-ligand 1 (PD-L1) was measured in tumor samples by immunohistochemical methods. This record summarizes the PD-L1 positivity percentage in tumor samples.
All patients who received at least one dose of study treatment in the Phase Ib part and had a valid assessment for the outcome measure, and all patients to whom study treatment was assigned by randomization in the Phase II part and had a valid assessment for the outcome measure.
Posted
Median
Full Range
PD-L1 positivity percentage
Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 115 days).
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
On-treatment and post-treatment safety follow-up deaths were collected from first dose of study medication to 150 days after the last dose of study medication.
Post-treatment survival follow-up deaths were collected from day 151 after last dose of study medication to end of study.
All deaths refer to the sum of on-treatment and post-treatment safety follow-up deaths plus post-treatment survival follow-up deaths.
All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.
Posted
Number
participants
On-treatment and post-treatment safety follow-up deaths: up to 3.6 years in Phase Ib and 2.6 years in Phase II. Post treatment survival follow-up deaths: up to 3.6 years in Phase Ib and 2.9 years in Phase II.
Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Time Frame
Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs
Description
Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
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
Phase Ib: Capmatinib 200mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU
AEs during on-treatment period and post-treatment safety follow-up (FU) (up to 150 days post-treatment)
3
6
1
6
6
6
EG001
Phase Ib: Capmatinib 300mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU
AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)
3
10
1
10
10
10
EG002
Phase Ib: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU
AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)
4
11
6
11
10
11
EG003
Phase II: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU
AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)
8
32
14
32
32
32
EG004
Phase II: Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU
AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)
Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
15
24
0
0
0
0
EG009
Phase II: Spartalizumab 300 mg Q3W - Post-treatment Survival FU
Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
10
17
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG0030 affected32 at risk
EG0041 affected30 at risk
EG0050 at risk
EG0060 at risk
EG0070 at risk
EG0080 at risk
EG0090 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Vision blurred
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Haemoperitoneum
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Post procedural fever
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood corticotrophin decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG0034 affected32 at risk
EG0043 affected30 at risk
EG0050 at risk
EG0060 at risk
EG0070 at risk
EG0080 at risk
EG0090 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Cataract
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Diplopia
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dry eye
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0023 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0022 affected11 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Aptyalism
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0020 affected11 at risk
EG003
Chapped lips
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected10 at risk
EG0023 affected11 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected10 at risk
EG0025 affected11 at risk
EG003
Plicated tongue
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0014 affected10 at risk
EG0020 affected11 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected10 at risk
EG0023 affected11 at risk
EG003
Asthenia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Chills
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Fatigue
General disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected10 at risk
EG0024 affected11 at risk
EG003
Influenza like illness
General disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Malaise
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Nodule
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Oedema
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA (24.0)
Systematic Assessment
EG0004 affected6 at risk
EG0016 affected10 at risk
EG0026 affected11 at risk
EG003
Pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected6 at risk
EG0010 affected10 at risk
EG0024 affected11 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Abscess neck
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Paronychia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected10 at risk
EG0025 affected11 at risk
EG003
Amylase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected10 at risk
EG0023 affected11 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected10 at risk
EG0022 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected10 at risk
EG0023 affected11 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Lipase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Platelet count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Weight decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Weight increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0023 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected10 at risk
EG0023 affected11 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected10 at risk
EG0020 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected11 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Serotonin syndrome
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0023 affected11 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0023 affected11 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected11 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected10 at risk
EG0024 affected11 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected10 at risk
EG0023 affected11 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Stasis dermatitis
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Haematoma
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hot flush
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Units
Counts
Participants
OG0006
OG0018
OG0029
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Units
Counts
Participants
OG0006
OG00110
OG00211
Title
Denominators
Categories
Capmatinib dose reduction
Title
Measurements
OG0002
OG0014
OG0028
Capmatinib dose interruption
Title
Measurements
OG0004
OG0016
OG0028
Spartalizumab dose reduction
Title
Measurements
OG0000
OG0010
OG0020
Spartalizumab dose interruption
Title
Measurements
OG0004
OG0014
OG0027
Units
Counts
Participants
OG0006
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG000391.2(294 to 400)
OG001580.0(390 to 600)
OG002755.6(371 to 800)
Units
Counts
Participants
OG0006
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG000293.18(235.7 to 300.0)
OG001300.00(225.0 to 300.0)
OG002300.00(272.7 to 300.0)
Units
Counts
Participants
OG00032
OG00130
Title
Denominators
Categories
Title
Measurements
OG0009.4(2.0 to 25.0)
OG00110.0(2.1 to 26.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Bayesian Logistic Regression Model
Odds Ratio (OR)
0.561
Posterior probability that the odds ratio (ORRspartalizumab +capmatinib to ORRspartalizumab) was ≥ 1
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG00033.3(4.3 to 77.7)
OG0010(0.0 to 30.8)
OG00227.3(6.0 to 61.0)
OG00312.5(3.5 to 29.0)
OG00410.0(2.1 to 26.5)
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0002
OG0010
OG0022
OG0033
OG0043
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG002NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG003NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG004NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0002
OG0010
OG0023
OG0034
OG0043
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG002NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG003NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG004NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG001NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG002NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG003NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG004NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG001NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG002NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG003NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
OG004NA(NA to NA)The estimate could not be provided due to the insufficient number of responders as per SAP.
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG0003.42(1.18 to NA)Not estimable due to insufficient number of participants with events.
OG0014.44(1.25 to NA)Not estimable due to insufficient number of participants with events.
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG0003.42(1.18 to NA)Not estimable due to insufficient number of participants with events.
OG0014.44(1.68 to NA)Not estimable due to insufficient number of participants with events.
OG0025.55(1.25 to NA)Not estimable due to insufficient number of participants with events.
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG0003.42(1.18 to NA)Not estimable due to insufficient number of participants with events.
OG0014.44(1.25 to NA)Not estimable due to insufficient number of participants with events.
OG0021.35(1.22 to NA)Not estimable due to insufficient number of participants with events.
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG0003.42(1.18 to NA)Not estimable due to insufficient number of participants with events.
OG0014.44(1.68 to NA)Not estimable due to insufficient number of participants with events.
OG0025.55(1.25 to NA)Not estimable due to insufficient number of participants with events.
OG0033.06(2.63 to 4.17)
OG0042.79(1.61 to 5.75)
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG00014.98(2.37 to NA)Not estimable due to insufficient number of participants with events.
OG00112.11(1.68 to 19.45)
OG00216.53(2.83 to NA)Not estimable due to insufficient number of participants with events.
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00332
ParticipantsOG00430
Title
Measurements
OG000739± 24.7
OG001726± 20.9
OG002813± 19.4
OG003
Cycle 3
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG00327
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0004
OG0019
OG0028
OG00322
OG00423
Tumor samples
OG0005
OG00115
OG00210
OG00329
OG004
Title
Denominators
Categories
Baseline
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG00319
ParticipantsOG00419
Tumor samplesOG0004
Tumor samplesOG0017
Tumor samplesOG0027
Tumor samplesOG00319
Tumor samplesOG004
Title
Measurements
OG0000.6(0 to 1)
OG0010.9(0 to 37)
OG0020.4(0 to 3)
OG003
Post-baseline
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG00310
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib
Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
OG004
Phase II: Spartalizumab 300 mg Q3W
Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Units
Counts
Participants
OG0006
OG00110
OG00211
OG00332
OG00430
Title
Denominators
Categories
On-treatment and post-treatment safety follow-up deaths