Trial Outcomes & Findings for A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (PC) Patients (NCT NCT04581343)

Last Updated: 2025-05-04

Results Overview

Evaluate dose limiting toxicities of patients with metastatic pancreatic cancer for at least 56 days (DLT period) after dosing with canakinumab at 250 mg every 4 weeks (Q4W), 400mg Spartalizumab Q4W and Gemcitabine/nab-paclitaxel on Days 1, 8 and 15 at standard of care levels. Dose limiting toxicities were evaluated to determine if dosing of canakinumab at 250 mg every 4 weeks with the other three drugs was considered tolerable and should be the dose utilized for future Phase 2/3 clinical trials. The starting dose level of canakinumab explored was 250 mg every 4 weeks (Q4W) ("starting dose level"). In case of unacceptable toxicity of canakinumab at 250 mg Q4W, the dose of canakinumab was to be de-escalated to 250 mg every 8 weeks, while other components of the combination were kept at the same dose as the starting dose level. Approximately 10 patients were to be enrolled in this study to have at least 6 evaluable patients per dose level of canakinumab.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Assess the incidence of dose limiting toxicities (DLT) in the first 56 days (8 weeks) of dosing

Results posted on

2025-05-04

Participant Flow

All participants received 250mg s.c. Canakinumab and 400mg Spartalizumab Q4W and Gemcitabine/nab-paclitaxel per study design. No dose de-escalation occurred.

Participant milestones

Participant milestones
Measure	250 mg s.c. Q4W Canakinumab The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Overall Study STARTED	10
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Count of female participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=10 Participants
Age, Categorical >=65 years	6 Participants n=10 Participants
Age, Continuous	64.9 years STANDARD_DEVIATION 7.96 • n=10 Participants
Sex: Female, Male Female	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=10 Participants
Race (NIH/OMB) White	9 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants
Height	170.12 cm STANDARD_DEVIATION 8.444 • n=10 Participants
Weight	72.80 kg STANDARD_DEVIATION 12.251 • n=10 Participants
Body Mass Index (kg/m^2)	25.84 kg/m^2 STANDARD_DEVIATION 3.688 • n=10 Participants
Baseline Body Surface Area (m^2)	1.84 m^2 STANDARD_DEVIATION 0.174 • n=10 Participants
Childbearing potential for females Yes	0 Participants n=5 Participants • Count of female participants.
Childbearing potential for females No	5 Participants n=5 Participants • Count of female participants.

PRIMARY outcome

Timeframe: Assess the incidence of dose limiting toxicities (DLT) in the first 56 days (8 weeks) of dosing

Population: Included all patients from the safety analysis set who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 2 cycles (56 days \[8 weeks\]) of dosing.

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=6 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
The Incidence of DLTs in the First 56 Days (8 Weeks) of Dosing to Determine Tolerable Phase 2/3 Dose of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer. Patients with no DLTs during DLT period	5 Participants
The Incidence of DLTs in the First 56 Days (8 Weeks) of Dosing to Determine Tolerable Phase 2/3 Dose of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer. Patients with DLTs including grade 4 neutropenia of Unknown duration during DLT period	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of study treatment through Safety Follow-up period (150-days after the last study treatment)

Population: Included all patients treated with at least 1 dose of any of the constituent study treatments.

Determine the Safety of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine via frequency and severity of adverse events (AEs), serious and non-serious. To assess tolerability of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine via frequency of dose interruptions and dose reductions

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE	10 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE causally related to any drug	10 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE of CTCAE grade ≥3 causally related to any drug	9 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE with outcome of death	0 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TESAE	7 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TESAE causing discontinuation of any drug	2 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE causing discontinuation of any drug	2 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE leading to dose interval modified of canakinumab	2 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE leading to dose interruption of spartalizumab	3 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE leading to dose interruption of nab-paclitaxel	7 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE leading to dose interruption of gemcitabine	7 participants
To Determine the Safety and Tolerability of Canakinumab in Combination With Spartalizumab, Nab-paclitaxel, and Gemcitabine Any TEAE causing discontinuation of canakinumab causally related to any drug	1 participants

SECONDARY outcome

Timeframe: From Day 1 of study treatment through End of Treatment visit, an average of 6 months

Population: Included all patients treated with at least 1 dose of any of the constituent study treatments.

Determine the Tolerability through frequency of dose interruptions and dose reductions of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Determine the Tolerability of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Number of Patients with a Dose Reduction of Canakinumab	0 participants
Determine the Tolerability of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Number of Patients with a Reduction in Frequency from Q4W to Q8W of Canakinumab	0 participants
Determine the Tolerability of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Number of Patients with neither Dose Interruption nor Dose Reduction of Spartalizumab	10 participants
Determine the Tolerability of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Number of Patients with at least one Dose Interruption or Dose Reduction of Nab-Paclitaxel	6 participants
Determine the Tolerability of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Number of Patients with at least one Dose Interruption or Dose Reduction of Gemcitabine	6 participants

SECONDARY outcome

Timeframe: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months;

Population: Objective response rate is defined as the proportion of patients with Best Overall Response (BOR) of CR or PR per RECIST v1.1 and will be based on a subset of all treated patients with measurable disease at baseline per the site investigator.

Objective Response Rate (ORR) and Duration of Response (DOR) are calculated based on tumor response data \[complete Response (CR) and Partial Response (PR)\] assessed at the local site using RECIST 1.1 Criteria of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine. Per Overall Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT Scans: Complete Response(CR), Disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.; Objective/Overall Response Rate (ORR) = CR or PR.

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Determine the Response-related Efficacy Assessments Objective Response Rate (ORR) and Duration of Response (DOR) of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Achieved Complete Response	0 participants
Determine the Response-related Efficacy Assessments Objective Response Rate (ORR) and Duration of Response (DOR) of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Achieved Partial Response	2 participants

SECONDARY outcome

Timeframe: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months;

Population: DCR is defined as the proportion of patients with a BOR of CR, PR or SD (without subsequent cancer therapy) for at least 7 weeks after start of treatment as per RECIST v1.1 and will be based on a subset of all treated patients with measurable disease at baseline per the site investigator

The Disease Control Rate (DCR) is calculated based on tumor response data \[complete Response (CR) and Partial Response (PR) and Stable Disease (SD)\] assessed at the local site using RECIST 1.1 Criteria of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Determine the Disease Control Rate (DCR) of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Disease Control	8 Participants
Determine the Disease Control Rate (DCR) of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer Progression	2 Participants

SECONDARY outcome

Timeframe: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months;

Population: Included all patients treated with at least 1 dose of any of the constituent study treatments and both screening and on treatment study scans.

The Progression Free Survival is defined as the time from the date of the first dose to the date of disease progression, assessed at the local site using RECIST 1.1 Criteria, of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Determine the Progression Free Survival (PFS) of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer	4.60 months Interval 1.875 to 7.566

SECONDARY outcome

Timeframe: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months;

Population: Included all patients treated with at least 1 dose of any of the constituent study treatments and either a CR or PR.

The Time To Response Rate is defined as the time from the date of the first dose to the date of first documented tumor response \[Complete Response (CR) or Partial Response (PR)\], assessed at the local site using RECIST 1.1 Criteria, of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine. TTR is only assessed for patients with either CR or PR.

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=2 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Determine the Time To Response Rate (TTR) of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer	4.9 months Interval 1.71 to 8.09

SECONDARY outcome

Timeframe: Overall Survival assessment will be from first day of study treatment, through safety follow up period, and until subject's date of death, or until study closure

Population: Included all patients treated with at least 1 dose of any of the constituent study treatments.

The Overall Survival is defined as the time from the date of the first dose to the date of death, due to any cause, of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Determine the Overall Survival (OS) of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer	12.90 months Interval 3.651 to 21.711

SECONDARY outcome

Timeframe: Pharmacokinetic (PK) blood draws will be taken during cycles 1-6 for canakinumab analyte; Every cycle is 28-days, total estimated time is 6 months;

Population: Pharmacokinetic analysis set (PAS) canakinumab : included all patients who received at least 1 dose of canakinumab and had at least 1 reportable concentration of canakinumab.

Characterize the Descriptive Statistics (n, m (number of non-zero concentrations), mean, coefficient of variation (CV)%, SD, median, geometric mean, geometric CV%, minimum and maximum) of the Pharmacokinetic (PK) blood samples of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine;

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Characterize the Pharmacokinetics of Canakinumab in Patients With Metastatic Pancreatic Cancer	204 hours (t-max) Interval 142.0 to 506.0

SECONDARY outcome

Timeframe: Pharmacokinetic (PK) blood draws will be taken during cycles 1-6 for spartalizumab analyte; Every cycle is 28-days, total estimated time is 6 months;

Population: PAS spartalizumab : included all patients who received at least 1 dose of spartalizumab and had at least 1 reportable concentration of spartalizumab .

Characterize the Descriptive Statistics (n, m (number of non-zero concentrations), mean, coefficient of variation CV%, SD, median, geometric mean, geometric CV%, minimum and maximum) of the Pharmacokinetic (PK) blood samples of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine;

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=9 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Characterize the Pharmacokinetics of Spartalizumab in Patients With Metastatic Pancreatic Cancer	0.533 hours (t-max) Interval 0.5 to 0.617

SECONDARY outcome

Timeframe: Pharmacokinetic (PK) blood draws will be taken during cycles 1 and 2 for nab-paclitaxel analyte; Every cycle is 28-days, total estimated time is 2 months;

Population: PAS nab-paclitaxel: included all patients who received at least 1 dose of nab-paclitaxel land had at least 1 reportable concentration of nab-paclitaxel.

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Characterize the Pharmacokinetics of Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer C1D1	0.583 hours (t-max) Interval 0.567 to 0.717
Characterize the Pharmacokinetics of Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer C2D1	0.592 hours (t-max) Interval 0.533 to 0.65

SECONDARY outcome

Timeframe: Pharmacokinetic (PK) blood draws will be taken during cycles 1 and 2 for gemcitabine analyte; Every cycle is 28-days, total estimated time is 2 months;

Population: PAS gemcitabine : included all patients who received at least 1 dose of gemcitabine and had at least 1 reportable concentration of gemcitabine.

Outcome measures

Outcome measures
Measure	250 mg s.c. Q4W Canakinumab n=10 Participants The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Characterize the Pharmacokinetics of Gemcitabine in Patients With Metastatic Pancreatic Cancer C1D1- GEM	0.533 hours (t-max) Interval 0.4 to 0.717
Characterize the Pharmacokinetics of Gemcitabine in Patients With Metastatic Pancreatic Cancer C2D1- GEM	0.558 hours (t-max) Interval 0.533 to 0.567
Characterize the Pharmacokinetics of Gemcitabine in Patients With Metastatic Pancreatic Cancer C1D1- dFdu	0.550 hours (t-max) Interval 0.4 to 4.67
Characterize the Pharmacokinetics of Gemcitabine in Patients With Metastatic Pancreatic Cancer C2D1- dFdu	0.558 hours (t-max) Interval 0.533 to 0.567

Adverse Events

250 mg s.c. Q4W Canakinumab

Serious events: 7 serious events

Other events: 10 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	250 mg s.c. Q4W Canakinumab n=10 participants at risk The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Blood and lymphatic system disorders Anaemia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Blood and lymphatic system disorders Neutropenia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Enterocolitis	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Gastrointestinal Disorder	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Gastrointestinal Haemorrhage	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
General disorders Influenza Like Illness	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Hepatobiliary disorders Biliary Obstruction	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Device Related Infection	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Liver Abscess	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Sepsis	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Septic Shock	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Urinary Tract Infection	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hypoglycaemia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Renal and urinary disorders Acute Kidney Injury	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Vascular disorders Peripheral Ischaemia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.

Other adverse events

Other adverse events
Measure	250 mg s.c. Q4W Canakinumab n=10 participants at risk The study treatment is defined as spartalizumab with canakinumab in combination with gemcitabine and nab-paclitaxel.
Blood and lymphatic system disorders Anaemia	100.0% 10/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Blood and lymphatic system disorders Neutropenia	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Blood and lymphatic system disorders Thrombocytopenia	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Cardiac disorders Sinus tachycardia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Endocrine disorders Hypothyroidism	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Endocrine disorders Hyperthyroidism	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Eye disorders Retinopathy	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Eye disorders Vision blurred	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Constipation	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Diarrhoea	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Nausea	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Abdominal pain	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Vomiting	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Stomatitis	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Abdominal pain upper	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Dry mouth	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Enterocolitis	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Gastrointestinal disorder	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Gastrointestinal disorders Gastrointestinal haemorrhage	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
General disorders Fatigue	80.0% 8/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
General disorders Oedema peripheral	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
General disorders Pyrexia	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
General disorders Influenza like illness	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
General disorders Non-cardiac chest pain	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
General disorders Malaise	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Hepatobiliary disorders Biliary obstruction	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Pneumonia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Urinary tract infection	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Device related infection	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Liver abscess	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Sepsis	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Septic shock	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Skin infection	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Infections and infestations Vulvovaginal mycotic infection	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Injury, poisoning and procedural complications Contusion	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Alanine aminotransferase increased	90.0% 9/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Aspartate aminotransferase increased	90.0% 9/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Blood alkaline phosphatase increased	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Neutrophil count decreased	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Platelet count decreased	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Lipase increased	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Lymphocyte count decreased	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations White blood cell count decreased	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Amylase increased	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Weight decreased	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Blood bilirubin increased	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Blood creatinine increased	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Blood lactate dehydrogenase increased	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Activated partial thromboplastin time prolonged	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Blood thyroid stimulating hormone decreased	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations Blood thyroid stimulating hormone increased	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Investigations International normalised ratio increased	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hypoalbuminaemia	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Decreased appetite	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hyponatraemia	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Dehydration	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hyperglycaemia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hyperkalaemia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hypocalcaemia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hypokalaemia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hypoglycaemia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Metabolism and nutrition disorders Hypomagnesaemia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Musculoskeletal and connective tissue disorders Bone pain	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Musculoskeletal and connective tissue disorders Flank pain	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Nervous system disorders Dysgeusia	50.0% 5/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Nervous system disorders Peripheral sensory neuropathy	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Nervous system disorders Aphasia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Nervous system disorders Headache	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Nervous system disorders Neuropathy peripheral	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Psychiatric disorders Insomnia	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Psychiatric disorders Anxiety	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Renal and urinary disorders Pollakiuria	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Renal and urinary disorders Acute kidney injury	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Renal and urinary disorders Dysuria	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Renal and urinary disorders Haematuria	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Renal and urinary disorders Proteinuria	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	40.0% 4/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Reproductive system and breast disorders Allergic cough	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Alopecia	60.0% 6/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	30.0% 3/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Pruritus	20.0% 2/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Actinic keratosis	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Dermatitis acneiform	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Nail pigmentation	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Petechiae	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Rash	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Skin and subcutaneous tissue disorders Skin ulcer	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Vascular disorders Hypertension	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Vascular disorders Hypotension	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.
Vascular disorders Peripheral ischaemia	10.0% 1/10 • All S/AEs, including any laboratory abnormalities, that fit the reportable criteria described in protocol, will be recorded from the time the patient signs the Informed Consent Form (ICF) until 150 days (5 months) after the last dose of study treatment of canakinumab or spartalizumab (due to the half-life of these drugs) up to 626 days/20.6 months.

Additional Information

Samantha Pedersen, Sr. Director Clinical Operations

PanCAN

Phone: 310.706.3726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60