Trial Outcomes & Findings for Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers (NCT NCT03122548)

Last Updated: 2019-04-04

Results Overview

ORR was evaluated based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each evaluable subject as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR RECIST v1.1 values of CR, PR, SD, PD, and NE are provided for this outcome measure. .

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.

Results posted on

2019-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	CRS-207 + Pembrolizumab Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 colony forming units (CFU) administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	CRS-207 + Pembrolizumab Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 colony forming units (CFU) administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Overall Study Death	2
Overall Study Progression - subject went into hospice	1
Overall Study Study Terminated by Sponsor	2

Baseline Characteristics

Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRS-207 + Pembrolizumab n=5 Participants Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 13.05 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.

Population: Analysis based upon subjects who received at least 1 dose of CRS-207 and had at least 1 evaluable post-baseline RECIST v1.1 tumor response assessment or were discontinued due to toxicity (the Evaluable Analysis Set \[EAS\]). 2 subjects did not have post-baseline tumor response assessments and could not be evaluated for this outcome measure.

Outcome measures

Outcome measures
Measure	CRS-207 + Pembrolizumab n=3 Participants Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Objective Response Rate (ORR) Complete Response	0 Participants
Objective Response Rate (ORR) Partial Response	0 Participants
Objective Response Rate (ORR) Stable Disease	0 Participants
Objective Response Rate (ORR) Progressive Disease	3 Participants
Objective Response Rate (ORR) Not Evaluable	0 Participants

SECONDARY outcome

The percentage of evaluable subjects who exhibited a post-baseline tumor assessment BOR rating of CR, PR, or SD per RECIST v1.1.

Outcome measures

Outcome measures
Measure	CRS-207 + Pembrolizumab n=5 Participants Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Disease Control Rate (DCR)	0 Participants

SECONDARY outcome

Timeframe: Subjects followed for disease progression from first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.

Population: Analysis of PFS was performed on subjects in the SAF.

Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) according to RECIST v1.1 or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects who do not experience PD and are alive on or before the data cut-off date will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.

Outcome measures

Outcome measures
Measure	CRS-207 + Pembrolizumab n=5 Participants Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Progression-Free Survival (PFS)	5.43 weeks Interval 0.14 to 6.0

SECONDARY outcome

Timeframe: DOR assessed from the date of a post-baseline tumor assessment of CR or PR per RECIST v1.1 until the date of documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.

Population: No study subjects achieved CR or PR designation, therefore, per the final SAP DOR was not derived.

Number of weeks from the first date a study subject achieved an objective disease response of CR or PR according to RECIST v1.1 to the date a study subject exhibited PD or death due to any cause, estimated using KM methods with 95% CIs. Subjects who do not experience PD or death at the time of analysis will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.

Outcome measures

Outcome measures
Measure	CRS-207 + Pembrolizumab n=5 Participants Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Duration of Response (DOR)	0 Participants

SECONDARY outcome

Timeframe: OS was assessed from the first dose of study treatment until death or study termination, whichever is earlier, assessed up to 15 weeks.

Population: Analysis of OS was performed on subjects in the SAF.

Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive, or the data cut-off date, whichever is earlier.

Outcome measures

Outcome measures
Measure	CRS-207 + Pembrolizumab n=5 Participants Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Overall Survival (OS)	11.57 weeks Interval 4.0 to 14.43

Adverse Events

CRS-207 + Pembrolizumab

Serious events: 4 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	CRS-207 + Pembrolizumab n=5 participants at risk Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
Gastrointestinal disorders Obstruction Gastric	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Hepatobiliary disorders Hepatic Failure	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Infections and infestations Bacteraemia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Nervous system disorders Hepatic Encephalopathy	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.

Other adverse events

Other adverse events
Measure	CRS-207 + Pembrolizumab n=5 participants at risk Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
General disorders Chills	80.0% 4/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
General disorders Pyrexia	80.0% 4/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
General disorders Fatigue	60.0% 3/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
General disorders Oedema Peripheral	40.0% 2/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
General disorders Pain	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Gastrointestinal disorders Vomiting	40.0% 2/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Gastrointestinal disorders Abdominal Pain Upper	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Gastrointestinal disorders Constipation	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Gastrointestinal disorders Dysphagia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Gastrointestinal disorders Flatulence	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Gastrointestinal disorders Nausea	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Gastrointestinal disorders Obstruction Gastric	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Metabolism and nutrition disorders Decreased Appetite	80.0% 4/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Metabolism and nutrition disorders Dehydration	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Metabolism and nutrition disorders Hypercalcaemia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	40.0% 2/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Vascular disorders Hypertension	40.0% 2/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Vascular disorders Hypotension	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Musculoskeletal and connective tissue disorders Back Pain	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Musculoskeletal and connective tissue disorders Muscular Weakness	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Nervous system disorders Dysgeusia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Nervous system disorders Hepatic Encephalopathy	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Nervous system disorders Memory Impairment	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Nervous system disorders Paraesthesia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Blood and lymphatic system disorders Anaemia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Cardiac disorders Sinus Tachycardia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Hepatobiliary disorders Hepatic Failure	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Infections and infestations Bacteraemia	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Investigations Aspartate Aminotransferase Increased	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Investigations Blood Alkaline Phosphatase Increased	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Investigations Blood Sodium Decreased	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Investigations Lymphocyte Count Decreased	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Investigations Weight Decreased	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Psychiatric disorders Anxiety	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Psychiatric disorders Depression	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks. AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.

Additional Information

Medical Affairs

Aduro Biotech, Inc.

Phone: 510.809.2452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction is that study results will first be published in a joint multi-center paper unless (a) written confirmation is provided to the site or PI indicating that there will be no multi-center publication, or (b) at least 12 months have passed after the completion of data analysis at all study sites. Publications will be submitted for sponsor review ≥ 30 days prior to the publication date. Sponsor cannot require changes to the communication or extend the embargo.
Publication restrictions are in place

Restriction type: OTHER