Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat... | NCT02954991

Label	Type	Description	Intervention Names
Glesatinib and Nivolumab	Experimental	Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week	Drug: Glesatinib Drug: Nivolumab
Sitravatinib and Nivolumab	Experimental	Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week	Drug: Sitravatinib Drug: Nivolumab
Mocetinostat and Nivolumab	Experimental	Mocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week	Drug: Mocetinostat Drug: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Glesatinib	Drug	Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor	Glesatinib and Nivolumab

Measure	Description	Time Frame
Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	ORR is defined as the percentage of participants that were documented to have a confirmed complete response (CR) or partial response (PR) as defined by RECIST v1.1.	Up to 40.6 months

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	TEAEs were defined as any event that first occur or increase in severity on or after the first dose of study treatment and not more than 28 days after the last dose of study treatment and prior to the initiation of subsequent systemic anti- cancer therapy. Any clinically significant changes in laboratory tests were recorded as TEAEs.

Facility	Status	City	State	ZIP	Country	Contacts
Yuma Regional Medical Center		Yuma	Arizona	85364	United States
Beverly Hills Cancer Center

ID	Title	Description
FG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously received checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
FG001	CIT Naïve: Sitravatinib and Nivolumab

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 11, 2020	Jan 25, 2024

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

Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

ORR is defined as the percentage of participants that were documented to have a confirmed complete response (CR) or partial response (PR) as defined by RECIST v1.1.

The Full Analysis Set (FAS) was defined as all participants who received at least 1 dose of both study treatments (sitravatinib or glesatinib) and nivolumab. Data was only planned to be reported for participants in the Phase 2 study, so no data is present for the 5 participants who received glesatinib in the lead- in phase only.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 40.6 months

ID	Title	Description
OG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously received checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
OG001	CIT Naïve: Sitravatinib and Nivolumab	Participants who had not previously received CIT received sitravatinib 120 mg oral capsules QD in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.

Units	Counts
Participants	OG000124 OG00132

Title

Denominators

Categories

Title	Measurements
	OG00015.3(9.5 to 22.9) OG00125(11.5 to 43.4)

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

TEAEs were defined as any event that first occur or increase in severity on or after the first dose of study treatment and not more than 28 days after the last dose of study treatment and prior to the initiation of subsequent systemic anti- cancer therapy.

Any clinically significant changes in laboratory tests were recorded as TEAEs.

The Safety Population was defined as all participants who received at least 1 dose of any study treatment (sitravatinib, glesatinib, or nivolumab). Per statistical analysis plan, only AEs for sitravatinib + nivolumab will be summarized. TEAE tables for glesatinib + nivolumab were not produced and therefore will not be reported here.

Posted

Count of Participants

Participants

Day 1 up to 28 days after the last dose (median time on treatment was: CIT experienced 3.7 months; CIT naïve 4.8 months)

ID	Title	Description
OG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously received checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
OG001	CIT Naïve: Sitravatinib and Nivolumab	Participants who had not previously received CIT received sitravatinib 120 mg oral capsules QD in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.

Secondary

Duration of Response (DOR)

DOR was defined as the time in months from date of the first documentation of objective response (CR or PR) to the first documentation of objective progressive disease (PD) or to death due to any cause in the absence of documented PD. (Be aware, the population analyzed here is the Clinical Activity Evaluable Population and not the Full Analysis Set as used in outcome measure 1).

Clinical Activity Evaluable Population was defined as all participants who received at least 1 dose of both study treatments (sitravatinib or glesatinib) and nivolumab, had an evaluable baseline tumor assessment, and ≥ 1 postbaseline tumor assessment. DOR was only calculated for the participants that achieved a confirmed CR or PR.

Posted

Median

95% Confidence Interval

months

Up to 38.8 months

ID	Title	Description
OG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously received checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
OG001	CIT Naïve: Sitravatinib and Nivolumab	Participants who had not previously received CIT received sitravatinib 120 mg oral capsules QD in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.

Secondary

Progression Free Survival (PFS)

PFS was defined as the time from the first dose of study drug to the date of PD or death due to any cause in the absence of documented PD, whichever occurs first.

The FAS was defined as all participants who received at least 1 dose of both study treatment (sitravatinib or glesatinib) and nivolumab. Data was only planned to be collected for participants in the Phase 2 study, so no data is present for the 5 participants who received glesatinib in the lead-in phase only.

Posted

Median

95% Confidence Interval

months

Up to 40.6 months

ID	Title	Description
OG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously received checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
OG001	CIT Naïve: Sitravatinib and Nivolumab	Participants who had not previously received CIT received sitravatinib 120 mg oral capsules QD in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.

Units	Counts
Participants

Secondary

Overall Survival (OS)

OS was defined as the time from first dose of study drug to the date of death due to any cause.

FAS was defined as all participants who received at least 1 dose of both study treatments (sitravatinib or glesatinib) and nivolumab. Data was only planned to be collected for participants in the Phase 2 study, so no data is present for the 5 participants who received glesatinib in the lead-in phase only.

Posted

Median

95% Confidence Interval

months

Up to 43.8 months

ID	Title	Description
OG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously received checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
OG001	CIT Naïve: Sitravatinib and Nivolumab	Participants who had not previously received CIT received sitravatinib 120 mg oral capsules QD in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.

Units	Counts
Participants

Secondary

Blood Plasma Concentrations

Predose (trough) concentrations for sitravatinib

Posted

Mean

Standard Deviation

ng/ml

Cycle 1 Day 1 through Cycle 5 Day 1

ID	Title	Description
OG000	Cycle 1 Day 15	Summary of all patients sitravatinib 120mg QD trough concentrations at C1D15
OG001	Cycle 2 Day 1	Summary of all patients sitravatinib 120mg QD trough concentrations at C2D1
OG002	Cycle 2 Day 15	Summary of all patients sitravatinib 120mg QD trough concentrations at C2D15
OG003	Cycle 3 Day 1	Summary of all patients sitravatinib 120mg QD trough concentrations at C3D1
OG004	Cycle 5 Day 1	Summary of all patients sitravatinib 120mg QD trough concentrations at C5D1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Myocarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Adrenalitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Encephalitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Gangrene	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Pneumonia viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Ejection fraction decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Troponin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Ataxia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Delirium	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0021 events1 affected5 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00027 events27 affected124 at risk EG00111 events11 affected32 at risk EG0020 events0 affected5 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00012 events12 affected124 at risk EG0014 events4 affected32 at risk EG0020 events0 affected5 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Hypothyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG00030 events30 affected124 at risk EG00113 events13 affected32 at risk EG0020 events0 affected5 at risk
Vision blurred	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00023 events23 affected124 at risk EG0015 events5 affected32 at risk EG0020 events0 affected5 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected124 at risk EG0010 events0 affected32 at risk EG0021 events1 affected5 at risk
Abdominal rigidity	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0010 events0 affected32 at risk EG0021 events1 affected5 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00031 events31 affected124 at risk EG00112 events12 affected32 at risk EG0020 events0 affected5 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00079 events79 affected124 at risk EG00120 events20 affected32 at risk EG0023 events3 affected5 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00017 events17 affected124 at risk EG0015 events5 affected32 at risk EG0020 events0 affected5 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00062 events62 affected124 at risk EG00116 events16 affected32 at risk EG0021 events1 affected5 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00020 events20 affected124 at risk EG0014 events4 affected32 at risk EG0020 events0 affected5 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00048 events48 affected124 at risk EG00112 events12 affected32 at risk EG0021 events1 affected5 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG00077 events77 affected124 at risk EG00121 events21 affected32 at risk EG0022 events2 affected5 at risk
Gait disturbance	General disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Mucosal inflammation	General disorders	MedDRA 10.0	Systematic Assessment	EG00012 events12 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG00017 events17 affected124 at risk EG0018 events8 affected32 at risk EG0021 events1 affected5 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00012 events12 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected124 at risk EG0014 events4 affected32 at risk EG0020 events0 affected5 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0014 events4 affected32 at risk EG0020 events0 affected5 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Alanine aminotransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG00028 events28 affected124 at risk EG0014 events4 affected32 at risk EG0022 events2 affected5 at risk
Amylase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG00027 events27 affected124 at risk EG0018 events8 affected32 at risk EG0022 events2 affected5 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG00018 events18 affected124 at risk EG0014 events4 affected32 at risk EG0020 events0 affected5 at risk
Blood creatinine increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected124 at risk EG0014 events4 affected32 at risk EG0020 events0 affected5 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected124 at risk EG0016 events6 affected32 at risk EG0020 events0 affected5 at risk
Lipase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG00014 events14 affected124 at risk EG0014 events4 affected32 at risk EG0021 events1 affected5 at risk
Lymphocyte count decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Platelet count decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected124 at risk EG0015 events5 affected32 at risk EG0020 events0 affected5 at risk
Weight decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG00057 events57 affected124 at risk EG00113 events13 affected32 at risk EG0020 events0 affected5 at risk
White blood cell count decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00062 events62 affected124 at risk EG00119 events19 affected32 at risk EG0020 events0 affected5 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00026 events26 affected124 at risk EG0018 events8 affected32 at risk EG0020 events0 affected5 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected124 at risk EG0017 events7 affected32 at risk EG0020 events0 affected5 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00033 events33 affected124 at risk EG0018 events8 affected32 at risk EG0020 events0 affected5 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00016 events16 affected124 at risk EG0017 events7 affected32 at risk EG0020 events0 affected5 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00023 events23 affected124 at risk EG0016 events6 affected32 at risk EG0020 events0 affected5 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00025 events25 affected124 at risk EG0018 events8 affected32 at risk EG0021 events1 affected5 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00031 events31 affected124 at risk EG00110 events10 affected32 at risk EG0020 events0 affected5 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00020 events20 affected124 at risk EG0015 events5 affected32 at risk EG0020 events0 affected5 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00021 events21 affected124 at risk EG0015 events5 affected32 at risk EG0021 events1 affected5 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0010 events0 affected32 at risk EG0021 events1 affected5 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected124 at risk EG0012 events2 affected32 at risk EG0021 events1 affected5 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected124 at risk EG0018 events8 affected32 at risk EG0020 events0 affected5 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00012 events12 affected124 at risk EG0017 events7 affected32 at risk EG0021 events1 affected5 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00019 events19 affected124 at risk EG0017 events7 affected32 at risk EG0020 events0 affected5 at risk
Dysgeusia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00014 events14 affected124 at risk EG0017 events7 affected32 at risk EG0020 events0 affected5 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00018 events18 affected124 at risk EG0016 events6 affected32 at risk EG0020 events0 affected5 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected124 at risk EG0010 events0 affected32 at risk EG0021 events1 affected5 at risk
Anxiety	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00010 events10 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected124 at risk EG0017 events7 affected32 at risk EG0020 events0 affected5 at risk
Proteinuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00014 events14 affected124 at risk EG0017 events7 affected32 at risk EG0020 events0 affected5 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00032 events32 affected124 at risk EG00115 events15 affected32 at risk EG0020 events0 affected5 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00042 events42 affected124 at risk EG00110 events10 affected32 at risk EG0020 events0 affected5 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00030 events30 affected124 at risk EG00110 events10 affected32 at risk EG0021 events1 affected5 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00014 events14 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected124 at risk EG0013 events3 affected32 at risk EG0020 events0 affected5 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0012 events2 affected32 at risk EG0020 events0 affected5 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00020 events20 affected124 at risk EG0018 events8 affected32 at risk EG0020 events0 affected5 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected124 at risk EG0014 events4 affected32 at risk EG0020 events0 affected5 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected124 at risk EG0016 events6 affected32 at risk EG0020 events0 affected5 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected124 at risk EG0011 events1 affected32 at risk EG0020 events0 affected5 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected124 at risk EG0011 events1 affected32 at risk EG0021 events1 affected5 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00041 events41 affected124 at risk EG00111 events11 affected32 at risk EG0020 events0 affected5 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected124 at risk EG0010 events0 affected32 at risk EG0020 events0 affected5 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously received checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
BG001	CIT Naïve: Sitravatinib and Nivolumab	Participants who had not previously received CIT received sitravatinib 120 mg oral capsules QD in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
BG002	Glesatinib and Nivolumab	Participants received glesatinib 500 mg oral tablets twice daily in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CIT Experienced: Sitravatinib and Nivolumab	Participants who had previously experienced checkpoint inhibitor therapy (CIT) received sitravatinib 120 mg oral capsules once daily (QD) in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.	92	124	62	124	122	124
EG001	CIT Naive: Sitravatinib and Nivolumab	Participants who had not previously experienced CIT received sitravatinib 120 mg oral capsules QD in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.	11	32	17	32	31	32
EG002	Glesatinib and Nivolumab	Participants received glesatinib 500 mg oral tablets twice daily in combination with nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks intravenously.	2	5	1	5	5	5

ID	Term
C000627807	glesatinib
C000611865	sitravatinib
C523184	mocetinostat
D000077594	Nivolumab