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Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT02864381
Recruitment Status : Completed
First Posted : August 12, 2016
Results First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Interventions Drug: Andecaliximab
Drug: Nivolumab
Enrollment 144
Recruitment Details Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 01 September 2016. The last study visit occurred on 23 August 2019.
Pre-assignment Details 187 participants were screened.
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis). Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
Period Title: Overall Study
Started 72 72
Completed 0 0
Not Completed 72 72
Reason Not Completed
Death             58             61
Withdrew Consent             5             6
Reason Unknown             7             3
Lost to Follow-up             1             1
Investigator's Discretion             1             0
Protocol Violation             0             1
Arm/Group Title Andecaliximab + Nivolumab Nivolumab Total
Hide Arm/Group Description Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis). Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis). Total of all reporting groups
Overall Number of Baseline Participants 72 72 144
Hide Baseline Analysis Population Description
The Intent-to-treat Analysis Set included all participants who were randomized in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 72 participants 144 participants
58  (12.1) 59  (11.8) 59  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 72 participants 144 participants
Female
23
  31.9%
22
  30.6%
45
  31.3%
Male
49
  68.1%
50
  69.4%
99
  68.8%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 72 participants 72 participants 144 participants
Asian
1
   1.4%
1
   1.4%
2
   1.4%
Black
2
   2.8%
0
   0.0%
2
   1.4%
White
55
  76.4%
61
  84.7%
116
  80.6%
Not Permitted
12
  16.7%
8
  11.1%
20
  13.9%
Other
2
   2.8%
2
   2.8%
4
   2.8%
[1]
Measure Description: Not Permitted=local regulators did not allow collection of race information.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 72 participants 72 participants 144 participants
Hispanic or Latino
2
   2.8%
3
   4.2%
5
   3.5%
Not Hispanic or Latino
59
  81.9%
61
  84.7%
120
  83.3%
Not Permitted
11
  15.3%
8
  11.1%
19
  13.2%
[1]
Measure Description: Not Permitted=local regulators did not allow collection of ethnicity information.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 72 participants 72 participants 144 participants
United Kingdom 17 18 35
United States 14 14 28
Belgium 5 10 15
France 9 6 15
Poland 5 9 14
Spain 10 4 14
Italy 8 5 13
Australia 2 5 7
Hungary 2 1 3
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Up to 41 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat Analysis Set included all participants who were randomized in the study.
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description:
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
Overall Number of Participants Analyzed 72 72
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
9.7
(4.0 to 19.0)
6.9
(2.3 to 15.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Andecaliximab + Nivolumab, Nivolumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments P-value is derived from Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification factor status.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.4 to 6.1
Estimation Comments Odds Ratio is derived from CMH test stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the interval in months from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause. The first definitive progressive disease (PD) was defined as the first radiation therapy, the first clinical PD, and the first confirmed imaging PD, whichever came first. Participants without PD or death and participants with PD after starting new anti-cancer therapy are censored at the last tumor assessment date.
Time Frame Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-treat Analysis Set were analyzed.
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description:
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
Overall Number of Participants Analyzed 72 72
Median (95% Confidence Interval)
Unit of Measure: months
1.840
(1.807 to 2.004)
1.856
(1.741 to 1.906)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Andecaliximab + Nivolumab, Nivolumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
Comments P-value is derived from log-rank test stratified by PD-L1 stratification factor status.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.836
Confidence Interval (2-Sided) 95%
0.589 to 1.189
Estimation Comments Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the interval from the date of randomization to death from any cause. Surviving participants are censored at the last date known alive.
Time Frame Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-treat Analysis Set were analyzed.
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description:
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
Overall Number of Participants Analyzed 72 72
Median (95% Confidence Interval)
Unit of Measure: months
7.162 [1] 
(4.797 to NA)
5.881
(3.483 to 10.908)
[1]
Upper 95% Confidence Interval was not reached due to the low number of participants with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Andecaliximab + Nivolumab, Nivolumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.312
Comments P-value is derived from log-rank test stratified by PD-L1 stratification factor status.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.786
Confidence Interval (2-Sided) 95%
0.491 to 1.257
Estimation Comments Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the interval from the date of the first response (complete or partial response) was achieved to the earlier of the first documentation of definitive disease progression or death from any cause.
Time Frame Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-treat Analysis Set who achieved CR or PR were analyzed.
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description:
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
Overall Number of Participants Analyzed 7 5
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(1.807 to NA)
NA [2] 
(2.037 to NA)
[1]
Median and Upper Limit of Confidence Interval (CI) were not estimable due to the low number of participants with events.
[2]
Median and Upper Limit of CI were not estimable due to the low number of participants with events.
5.Secondary Outcome
Title Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical study participants administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events that are defined as AEs with onset dates on or after the first dose of andecaliximab/nivolumab and up to 30 days after permanent discontinuation of andecaliximab or 5 months after permanent discontinuation of nivolumab, or led to premature discontinuation of andecaliximab or nivolumab.
Time Frame Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description:
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: percentage of participants
98.6 97.1
6.Secondary Outcome
Title Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hide Description Treatment-emergent (Chemistry, Hematology, Coagulation, and Urinalysis) laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of andecaliximab plus 30 days or nivolumab plus 5 months. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment-emergent. Percentage of participants with any postbaseline Grade 1 or higher laboratory abnormality is reported.
Time Frame Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description:
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: percentage of participants
Alanine aminotransferase increased Number Analyzed 70 participants 70 participants
20.0 27.1
Alkaline phosphatase increased Number Analyzed 71 participants 70 participants
45.1 40.0
Aspartate aminotransferase increased Number Analyzed 70 participants 70 participants
30.0 28.6
Blood bilirubin increased Number Analyzed 71 participants 70 participants
8.5 11.4
Chronic Kidney Disease Number Analyzed 71 participants 70 participants
16.9 25.7
Creatinine increased Number Analyzed 71 participants 70 participants
1.4 7.1
Hyperglycemia Number Analyzed 71 participants 70 participants
22.5 18.6
Hyperkalemia Number Analyzed 70 participants 70 participants
7.1 5.7
Hypermagnesemia Number Analyzed 71 participants 70 participants
2.8 1.4
Hypoalbuminemia Number Analyzed 71 participants 70 participants
35.2 38.6
Hypoglycemia Number Analyzed 71 participants 70 participants
11.3 4.3
Hypokalemia Number Analyzed 70 participants 70 participants
10.0 11.4
Hypomagnesemia Number Analyzed 71 participants 70 participants
5.6 4.3
Hyponatremia Number Analyzed 71 participants 70 participants
28.2 40.0
Hypophosphatemia Number Analyzed 71 participants 70 participants
11.3 8.6
Lipase increased Number Analyzed 71 participants 70 participants
11.3 8.6
Serum amylase increased Number Analyzed 71 participants 70 participants
9.9 7.1
Activated partial thromboplastin time prolonged Number Analyzed 39 participants 31 participants
2.6 19.4
International Normalized Ratio (INR) increased Number Analyzed 39 participants 32 participants
2.6 12.5
Anemia Number Analyzed 71 participants 69 participants
53.5 56.5
Lymphocytes, Typical count decreased Number Analyzed 71 participants 69 participants
35.2 27.5
Lymphocytes, Typical count increased Number Analyzed 71 participants 69 participants
4.2 0
Neutrophil count decreased Number Analyzed 71 participants 69 participants
5.6 5.8
Platelet count decreased Number Analyzed 71 participants 69 participants
8.5 5.8
White blood cell decreased Number Analyzed 71 participants 69 participants
9.9 7.2
Proteinuria (Dipstick) Number Analyzed 68 participants 67 participants
29.4 31.3
Time Frame All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
Adverse Event Reporting Description All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
 
Arm/Group Title Andecaliximab + Nivolumab Nivolumab
Hide Arm/Group Description Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis). Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
All-Cause Mortality
Andecaliximab + Nivolumab Nivolumab
Affected / at Risk (%) Affected / at Risk (%)
Total   61/72 (84.72%)   62/72 (86.11%) 
Hide Serious Adverse Events
Andecaliximab + Nivolumab Nivolumab
Affected / at Risk (%) Affected / at Risk (%)
Total   42/71 (59.15%)   38/70 (54.29%) 
Blood and lymphatic system disorders     
Anaemia † 1  5/71 (7.04%)  4/70 (5.71%) 
Cardiac disorders     
Ventricular fibrillation † 1  0/71 (0.00%)  1/70 (1.43%) 
Endocrine disorders     
Hypophysitis † 1  1/71 (1.41%)  0/70 (0.00%) 
Eye disorders     
Retinal disorder † 1  1/71 (1.41%)  0/70 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  3/71 (4.23%)  6/70 (8.57%) 
Abdominal pain upper † 1  1/71 (1.41%)  1/70 (1.43%) 
Anal haemorrhage † 1  0/71 (0.00%)  1/70 (1.43%) 
Ascites † 1  3/71 (4.23%)  2/70 (2.86%) 
Colitis † 1  0/71 (0.00%)  1/70 (1.43%) 
Constipation † 1  2/71 (2.82%)  0/70 (0.00%) 
Diarrhoea † 1  1/71 (1.41%)  0/70 (0.00%) 
Dysphagia † 1  4/71 (5.63%)  4/70 (5.71%) 
Gastric haemorrhage † 1  1/71 (1.41%)  0/70 (0.00%) 
Gastric perforation † 1  1/71 (1.41%)  0/70 (0.00%) 
Gastric stenosis † 1  1/71 (1.41%)  0/70 (0.00%) 
Gastrointestinal haemorrhage † 1  0/71 (0.00%)  3/70 (4.29%) 
Gastrointestinal obstruction † 1  0/71 (0.00%)  1/70 (1.43%) 
Gastrointestinal perforation † 1  1/71 (1.41%)  0/70 (0.00%) 
Haematemesis † 1  3/71 (4.23%)  0/70 (0.00%) 
Haemorrhoidal haemorrhage † 1  0/71 (0.00%)  1/70 (1.43%) 
Intestinal obstruction † 1  4/71 (5.63%)  0/70 (0.00%) 
Intestinal perforation † 1  1/71 (1.41%)  0/70 (0.00%) 
Large intestinal obstruction † 1  0/71 (0.00%)  1/70 (1.43%) 
Large intestine perforation † 1  0/71 (0.00%)  2/70 (2.86%) 
Melaena † 1  1/71 (1.41%)  1/70 (1.43%) 
Nausea † 1  3/71 (4.23%)  2/70 (2.86%) 
Obstruction gastric † 1  0/71 (0.00%)  2/70 (2.86%) 
Peritoneal haemorrhage † 1  0/71 (0.00%)  1/70 (1.43%) 
Small intestinal obstruction † 1  3/71 (4.23%)  0/70 (0.00%) 
Upper gastrointestinal haemorrhage † 1  2/71 (2.82%)  0/70 (0.00%) 
Vomiting † 1  3/71 (4.23%)  1/70 (1.43%) 
General disorders     
Complication associated with device † 1  1/71 (1.41%)  0/70 (0.00%) 
Euthanasia † 1  0/71 (0.00%)  2/70 (2.86%) 
General physical health deterioration † 1  0/71 (0.00%)  2/70 (2.86%) 
Oedema peripheral † 1  0/71 (0.00%)  1/70 (1.43%) 
Pyrexia † 1  2/71 (2.82%)  2/70 (2.86%) 
Hepatobiliary disorders     
Bile duct obstruction † 1  1/71 (1.41%)  0/70 (0.00%) 
Cholangitis † 1  1/71 (1.41%)  0/70 (0.00%) 
Cholestasis † 1  1/71 (1.41%)  0/70 (0.00%) 
Hepatic function abnormal † 1  0/71 (0.00%)  1/70 (1.43%) 
Hepatitis toxic † 1  1/71 (1.41%)  0/70 (0.00%) 
Hyperbilirubinaemia † 1  1/71 (1.41%)  0/70 (0.00%) 
Jaundice † 1  1/71 (1.41%)  0/70 (0.00%) 
Jaundice cholestatic † 1  0/71 (0.00%)  1/70 (1.43%) 
Infections and infestations     
Appendicitis † 1  0/71 (0.00%)  1/70 (1.43%) 
Cellulitis † 1  0/71 (0.00%)  1/70 (1.43%) 
Device related infection † 1  1/71 (1.41%)  1/70 (1.43%) 
Infection † 1  1/71 (1.41%)  0/70 (0.00%) 
Liver abscess † 1  1/71 (1.41%)  0/70 (0.00%) 
Lung abscess † 1  1/71 (1.41%)  0/70 (0.00%) 
Pneumonia † 1  2/71 (2.82%)  0/70 (0.00%) 
Postoperative wound infection † 1  0/71 (0.00%)  1/70 (1.43%) 
Sepsis † 1  2/71 (2.82%)  1/70 (1.43%) 
Septic shock † 1  1/71 (1.41%)  3/70 (4.29%) 
Subcutaneous abscess † 1  1/71 (1.41%)  0/70 (0.00%) 
Subdiaphragmatic abscess † 1  0/71 (0.00%)  1/70 (1.43%) 
Urosepsis † 1  0/71 (0.00%)  1/70 (1.43%) 
Vascular device infection † 1  0/71 (0.00%)  1/70 (1.43%) 
Injury, poisoning and procedural complications     
Accidental overdose † 1  0/71 (0.00%)  1/70 (1.43%) 
Investigations     
Blood alkaline phosphatase increased † 1  0/71 (0.00%)  1/70 (1.43%) 
Blood bilirubin increased † 1  1/71 (1.41%)  2/70 (2.86%) 
Blood creatinine increased † 1  0/71 (0.00%)  1/70 (1.43%) 
Blood magnesium decreased † 1  0/71 (0.00%)  1/70 (1.43%) 
General physical condition abnormal † 1  1/71 (1.41%)  0/70 (0.00%) 
Transaminases increased † 1  1/71 (1.41%)  0/70 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  2/71 (2.82%)  1/70 (1.43%) 
Dehydration † 1  1/71 (1.41%)  1/70 (1.43%) 
Hyponatraemia † 1  1/71 (1.41%)  1/70 (1.43%) 
Hypophagia † 1  0/71 (0.00%)  2/70 (2.86%) 
Malnutrition † 1  0/71 (0.00%)  1/70 (1.43%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  2/71 (2.82%)  1/70 (1.43%) 
Pain in extremity † 1  0/71 (0.00%)  1/70 (1.43%) 
Pathological fracture † 1  1/71 (1.41%)  0/70 (0.00%) 
Polymyalgia rheumatica † 1  1/71 (1.41%)  0/70 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain † 1  1/71 (1.41%)  0/70 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage † 1  0/71 (0.00%)  1/70 (1.43%) 
Dizziness † 1  0/71 (0.00%)  1/70 (1.43%) 
Hepatic encephalopathy † 1  1/71 (1.41%)  0/70 (0.00%) 
Myasthenia gravis † 1  1/71 (1.41%)  0/70 (0.00%) 
Seizure † 1  0/71 (0.00%)  1/70 (1.43%) 
Psychiatric disorders     
Confusional state † 1  0/71 (0.00%)  1/70 (1.43%) 
Renal and urinary disorders     
Acute kidney injury † 1  1/71 (1.41%)  1/70 (1.43%) 
Renal failure † 1  1/71 (1.41%)  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  2/71 (2.82%)  2/70 (2.86%) 
Hypoxia † 1  2/71 (2.82%)  0/70 (0.00%) 
Pleural effusion † 1  1/71 (1.41%)  1/70 (1.43%) 
Pleurisy † 1  1/71 (1.41%)  0/70 (0.00%) 
Pneumonia aspiration † 1  2/71 (2.82%)  0/70 (0.00%) 
Productive cough † 1  1/71 (1.41%)  0/70 (0.00%) 
Pulmonary embolism † 1  0/71 (0.00%)  1/70 (1.43%) 
Respiratory failure † 1  2/71 (2.82%)  0/70 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Andecaliximab + Nivolumab Nivolumab
Affected / at Risk (%) Affected / at Risk (%)
Total   66/71 (92.96%)   62/70 (88.57%) 
Blood and lymphatic system disorders     
Anaemia † 1  14/71 (19.72%)  14/70 (20.00%) 
Gastrointestinal disorders     
Abdominal distension † 1  4/71 (5.63%)  2/70 (2.86%) 
Abdominal pain † 1  11/71 (15.49%)  16/70 (22.86%) 
Abdominal pain upper † 1  11/71 (15.49%)  2/70 (2.86%) 
Ascites † 1  7/71 (9.86%)  4/70 (5.71%) 
Constipation † 1  18/71 (25.35%)  18/70 (25.71%) 
Diarrhoea † 1  14/71 (19.72%)  9/70 (12.86%) 
Dry mouth † 1  2/71 (2.82%)  5/70 (7.14%) 
Dyspepsia † 1  5/71 (7.04%)  2/70 (2.86%) 
Dysphagia † 1  12/71 (16.90%)  8/70 (11.43%) 
Gastrooesophageal reflux disease † 1  6/71 (8.45%)  2/70 (2.86%) 
Nausea † 1  27/71 (38.03%)  17/70 (24.29%) 
Vomiting † 1  22/71 (30.99%)  18/70 (25.71%) 
General disorders     
Asthenia † 1  21/71 (29.58%)  12/70 (17.14%) 
Chest pain † 1  1/71 (1.41%)  4/70 (5.71%) 
Fatigue † 1  22/71 (30.99%)  25/70 (35.71%) 
Oedema peripheral † 1  6/71 (8.45%)  6/70 (8.57%) 
Pyrexia † 1  10/71 (14.08%)  4/70 (5.71%) 
Infections and infestations     
Nasopharyngitis † 1  4/71 (5.63%)  0/70 (0.00%) 
Oral candidiasis † 1  3/71 (4.23%)  4/70 (5.71%) 
Urinary tract infection † 1  7/71 (9.86%)  1/70 (1.43%) 
Investigations     
Alanine aminotransferase increased † 1  4/71 (5.63%)  4/70 (5.71%) 
Aspartate aminotransferase increased † 1  4/71 (5.63%)  4/70 (5.71%) 
Weight decreased † 1  5/71 (7.04%)  7/70 (10.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  24/71 (33.80%)  20/70 (28.57%) 
Dehydration † 1  2/71 (2.82%)  5/70 (7.14%) 
Hyperkalaemia † 1  2/71 (2.82%)  4/70 (5.71%) 
Hypoalbuminaemia † 1  1/71 (1.41%)  4/70 (5.71%) 
Hypokalaemia † 1  5/71 (7.04%)  7/70 (10.00%) 
Hypomagnesaemia † 1  4/71 (5.63%)  1/70 (1.43%) 
Hyponatraemia † 1  2/71 (2.82%)  5/70 (7.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  4/71 (5.63%)  6/70 (8.57%) 
Back pain † 1  11/71 (15.49%)  5/70 (7.14%) 
Muscle spasms † 1  0/71 (0.00%)  4/70 (5.71%) 
Myalgia † 1  3/71 (4.23%)  4/70 (5.71%) 
Nervous system disorders     
Dizziness † 1  6/71 (8.45%)  8/70 (11.43%) 
Headache † 1  6/71 (8.45%)  6/70 (8.57%) 
Paraesthesia † 1  1/71 (1.41%)  4/70 (5.71%) 
Psychiatric disorders     
Anxiety † 1  5/71 (7.04%)  2/70 (2.86%) 
Insomnia † 1  3/71 (4.23%)  9/70 (12.86%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  4/71 (5.63%)  8/70 (11.43%) 
Dyspnoea † 1  10/71 (14.08%)  9/70 (12.86%) 
Skin and subcutaneous tissue disorders     
Pruritus † 1  3/71 (4.23%)  6/70 (8.57%) 
Vascular disorders     
Hypotension † 1  5/71 (7.04%)  2/70 (2.86%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
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Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02864381    
Other Study ID Numbers: GS-US-296-2013
2016-001402-41 ( EudraCT Number )
First Submitted: August 10, 2016
First Posted: August 12, 2016
Results First Submitted: August 18, 2020
Results First Posted: September 18, 2020
Last Update Posted: September 18, 2020