Trial Outcomes & Findings for Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor (NCT NCT03977467)

Last Updated: 2025-08-27

Results Overview

Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to the immune-modified RECIST criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Every 8 weeks until tumor progression or treatment discontinuation, up to 52 months.

Results posted on

2025-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A1 (NSCLC Chemo + Atezolizumab) Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.	Arm A2 (NSCLC Standard of Care Chemo) Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.	Arm B (Atezolizumab Only) In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.	Arm B (Atezolizumab and Tiragolumab) In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.
Overall Study STARTED	4	3	38	1
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	4	3	38	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A1 (NSCLC Chemo + Atezolizumab) Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.	Arm A2 (NSCLC Standard of Care Chemo) Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.	Arm B (Atezolizumab Only) In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.	Arm B (Atezolizumab and Tiragolumab) In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.
Overall Study Disease Progression	1	1	30	0
Overall Study Adverse Event	0	1	0	0
Overall Study Death	0	0	3	0
Overall Study Lack of Efficacy	0	0	1	0
Overall Study Withdrawal by Subject	2	1	4	0
Overall Study Study Terminated	1	0	0	1

Baseline Characteristics

Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A1 (NSCLC Chemo + Atezolizumab) n=4 Participants Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.	Arm A2 (NSCLC Standard of Care Chemo) n=3 Participants Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.	Arm B (Atezolizumab Only) n=38 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.	Arm B (Atezolizumab and Tiragolumab) n=1 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.	Total n=46 Participants Total of all reporting groups
Age, Continuous	61 years n=93 Participants	73 years n=4 Participants	66 years n=27 Participants	71 years n=483 Participants	66 years n=36 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	18 Participants n=27 Participants	1 Participants n=483 Participants	20 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	20 Participants n=27 Participants	0 Participants n=483 Participants	26 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	3 Participants n=4 Participants	36 Participants n=27 Participants	1 Participants n=483 Participants	43 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	4 participants n=93 Participants	3 participants n=4 Participants	38 participants n=27 Participants	1 participants n=483 Participants	46 participants n=36 Participants

PRIMARY outcome

Timeframe: Every 8 weeks until tumor progression or treatment discontinuation, up to 52 months.

Population: All enrolled and treated participants are included.

Outcome measures

Outcome measures
Measure	Arm A1 (NSCLC Chemo + Atezolizumab) n=4 Participants Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.	Arm A2 (NSCLC Standard of Care Chemo) n=3 Participants Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.	Arm B (Atezolizumab Only) n=38 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.	Arm B (Atezolizumab and Tiragolumab) n=1 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.
Overall Response Rate	50.0 percentage of participants	33.3 percentage of participants	7.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Every 3 weeks, up to 52 months

Population: All enrolled and treated participants are included.

The safety of atezolizumab combined with SOC chemotherapy (Arm A1), standard of care chemotherapy (Arm A2), single agent atezolizumab (Arm B), and atezolizumab combined with tiragolumab (Arm B atezo and tiragolumab) will be assessed through the analysis of the reported incidence of treatment-emergent AEs. Treatment-emergent AEs are those with an onset on or after the initiation of therapy, and will be graded according to NCI CTCAE 4.03.

Outcome measures

Outcome measures
Measure	Arm A1 (NSCLC Chemo + Atezolizumab) n=4 Participants Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.	Arm A2 (NSCLC Standard of Care Chemo) n=3 Participants Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.	Arm B (Atezolizumab Only) n=38 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.	Arm B (Atezolizumab and Tiragolumab) n=1 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.
Incidence of Treatment-emergent Adverse Events (AEs) as a Measure of Safety	4 Participants	3 Participants	34 Participants	1 Participants

SECONDARY outcome

Timeframe: Every 8 weeks until tumor progression or treatment discontinuation, up to 52 months.

Population: All enrolled and treated participants are included.

Disease control rate (DCR) in patients with NSCLC and other advanced solid tumors. Disease Control Rate (DCR) is defined as the percentage of participants with complete response (CR), partial response (PR), and participants with stable disease (SD) for at least 6 months according to the immune-modified RECIST criteria out of all treated participants.

Outcome measures

Outcome measures
Measure	Arm A1 (NSCLC Chemo + Atezolizumab) n=4 Participants Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.	Arm A2 (NSCLC Standard of Care Chemo) n=3 Participants Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.	Arm B (Atezolizumab Only) n=38 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.	Arm B (Atezolizumab and Tiragolumab) n=1 Participants In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.
Disease Control Rate (DCR)	50.0 percentage of participants	33.3 percentage of participants	7.7 percentage of participants	100.0 percentage of participants

Adverse Events

Arm A1 (NSCLC Chemo + Atezolizumab)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Arm A2 (NSCLC Standard of Care Chemo)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Arm B (Atezolizumab Only)

Serious events: 9 serious events

Other events: 34 other events

Deaths: 19 deaths

Arm B (Atezolizumab and Tiragolumab)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A1 (NSCLC Chemo + Atezolizumab) n=4 participants at risk Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.	Arm A2 (NSCLC Standard of Care Chemo) n=3 participants at risk Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.	Arm B (Atezolizumab Only) n=38 participants at risk In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.	Arm B (Atezolizumab and Tiragolumab) n=1 participants at risk In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.
Infections and infestations Sepsis	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders Muscular Weakness	25.0% 1/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders Atrial Fibrillation	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	100.0% 1/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Abdominal Wall Mass	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations COVID-19	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations COVID-19 Pneumonia	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders Dyspneoea	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations Klebsiella Infection	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations Stoma Site Abscess	0.00% 0/4 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/3 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	2.6% 1/38 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.	0.00% 0/1 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 52 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 52 months. All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Other adverse events

Additional Information

Sarah Cannon Development Innovations, LLC

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Email: [email protected]

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Principal investigator is a sponsor employee
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