Trial Outcomes & Findings for Olaparib With Ceralasertib in Recurrent Osteosarcoma (NCT NCT04417062)

Last Updated: 2026-08-20

Results Overview

An event is defined as the occurrence of relapse, disease progression as defined by RECIST 1.1, or death from any cause.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

4 months

Results posted on

2026-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Measurable Unresectable Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable Resectable disease limited to lung
Overall Study STARTED	39	10
Overall Study COMPLETED	37	6
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Measurable Unresectable Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable Resectable disease limited to lung
Overall Study Follow up	1	4
Overall Study Retrospectively Ineligible	1	0

Baseline Characteristics

1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Measurable Unresectable n=39 Participants Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable n=10 Participants Resectable disease limited to lung	Total n=49 Participants Total of all reporting groups
Age, Continuous	19.0 Years n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	19.3 Years n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	19.3 Years n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Sex: Female, Male Female	8 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	1 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	9 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Sex: Female, Male Male	30 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	9 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	39 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	0 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	0 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Race (NIH/OMB) Asian	3 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	1 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	4 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	0 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	0 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Race (NIH/OMB) Black or African American	4 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	1 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	5 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Race (NIH/OMB) White	20 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	4 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	24 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Race (NIH/OMB) More than one race	1 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	0 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	1 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	4 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	14 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	1 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	9 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	7 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	33 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=38 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	2 Participants n=10 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.	6 Participants n=48 Participants • 1 patient who was enrolled on Cohort 1 and started treatment was retrospectively deemed ineligible.

PRIMARY outcome

Timeframe: 4 months

Population: In Cohort 1, to be evaluable for the primary outcome measure, patients must be eligible and have received protocol therapy at the final dosing regimen.

An event is defined as the occurrence of relapse, disease progression as defined by RECIST 1.1, or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1: Measurable Unresectable n=34 Participants Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable Resectable disease limited to lung
Number of Participants Who Were Event-free at 4 Months (Cohort 1)	5 Participants	—

PRIMARY outcome

Timeframe: 2 months

Population: Cohort 2

The number of participants in Cohort 2 who provide both pre-treatment and post-treatment tumor specimens, allowing paired correlative analyses.

Outcome measures

Outcome measures
Measure	Cohort 1: Measurable Unresectable n=10 Participants Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable Resectable disease limited to lung
Number of Participants Submitted Both Pre/Post-treatment Tumor Specimen (Cohort 2)	7 Participants	—

SECONDARY outcome

Timeframe: 2 years

Population: Cohort 1

ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions

Outcome measures

Outcome measures
Measure	Cohort 1: Measurable Unresectable n=38 Participants Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable Resectable disease limited to lung
Objective Response Rate (Cohort 1)	5.3 Percentage of participants Interval 0.64 to 18.0	—

SECONDARY outcome

Timeframe: 12 months

The number of participants in Cohort 2 who remain event-free at 12 months after study enrollment. An event is defined as relapse, disease progression according to RECIST version 1.1, or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1: Measurable Unresectable n=10 Participants Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable Resectable disease limited to lung
Number of Participants Who Were Event-Free at 12 Months (Cohort 2)	4 Participants	—

SECONDARY outcome

Timeframe: 4 months (Cohort 1) and 12 months (Cohort 2)

EFS is defined as the time from study enrollment to the first occurrence of relapse, disease progression according to RECIST version 1.1, or death from any cause. Participants without an event at the time of analysis are censored at the date of their last disease assessment.

Outcome measures

Outcome measures
Measure	Cohort 1: Measurable Unresectable n=38 Participants Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable n=10 Participants Resectable disease limited to lung
Event Free Survival (EFS) at 4 Months (Cohort 1) and 12 Months (Cohort 2)	15.8 percentage of participants Interval 7.6 to 32.9	40 percentage of participants Interval 18.7 to 85.5

SECONDARY outcome

Timeframe: 4 months (Cohort 1) and 12 months (Cohort 2)

OS based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.

Outcome measures

Outcome measures
Measure	Cohort 1: Measurable Unresectable n=38 Participants Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable n=10 Participants Resectable disease limited to lung
Overall Survival (OS) at 4 Months (Cohort 1) and 12 Months (Cohort 2)	92.1 percentage of participants Interval 83.9 to 100.0	90 percentage of participants Interval 73.2 to 100.0

Adverse Events

Cohort 1: Measurable Unresectable

Serious events: 14 serious events

Other events: 39 other events

Deaths: 34 deaths

Cohort 2: Lung-only Resectable

Serious events: 2 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Katherine Janeway

Dana-Farber Cancer Institute

Phone: 6176324296

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort 1: Measurable Unresectable n=39 participants at risk Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable n=10 participants at risk Resectable disease limited to lung
Blood and lymphatic system disorders Anemia	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Cardiac disorders Pericardial effusion	5.1% 2/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Dysphagia	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Vomiting	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Disease progression	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Fatigue	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Appendicitis	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	20.0% 2/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Sepsis	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Wound infection	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Injury, poisoning and procedural complications Fracture	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Injury, poisoning and procedural complications Wound complication	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Platelet count decreased	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Nervous system disorders Spinal cord compression	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Reproductive system and breast disorders Pelvic pain	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Vascular disorders Vascular disorders - Other, specify	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.

Other adverse events
Measure	Cohort 1: Measurable Unresectable n=39 participants at risk Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Cohort 2: Lung-only Resectable n=10 participants at risk Resectable disease limited to lung
Blood and lymphatic system disorders Anemia	64.1% 25/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	70.0% 7/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Blood and lymphatic system disorders Eosinophilia	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Cardiac disorders Sinus tachycardia	10.3% 4/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	30.0% 3/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Eye disorders Photophobia	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Abdominal pain	5.1% 2/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Constipation	10.3% 4/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	50.0% 5/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Diarrhea	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	30.0% 3/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Dry mouth	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Mucositis oral	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Nausea	56.4% 22/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	70.0% 7/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Vomiting	15.4% 6/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	30.0% 3/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.1% 2/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Chills	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Edema limbs	5.1% 2/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	0.00% 0/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Fatigue	48.7% 19/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	60.0% 6/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Non-cardiac chest pain	7.7% 3/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	20.0% 2/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Fever	12.8% 5/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Flu like symptoms	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Localized edema	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
General disorders Pain	12.8% 5/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	30.0% 3/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Appendicitis	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Upper respiratory infection	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Wound infection	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Infections and infestations Infections and infestations - Other, specify	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Injury, poisoning and procedural complications Bruising	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Injury, poisoning and procedural complications Fall	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Injury, poisoning and procedural complications Wound complication	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Activated partial thromboplastin time prolonged	15.4% 6/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	20.0% 2/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Alanine aminotransferase increased	10.3% 4/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	20.0% 2/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Alkaline phosphatase increased	38.5% 15/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Aspartate aminotransferase increased	15.4% 6/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Blood bicarbonate decreased	10.3% 4/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	20.0% 2/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Blood bilirubin increased	12.8% 5/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	20.0% 2/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Blood lactate dehydrogenase increased	30.8% 12/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	50.0% 5/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations CPK increased	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Creatinine increased	23.1% 9/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	10.0% 1/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.
Investigations GGT increased	2.6% 1/39 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.	20.0% 2/10 • Adverse Events from enrollment to 30 days after last dose of study treatment. All-Cause Mortality up to 2 years after last dose of study treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was utilized for AE reporting. All serious adverse events (related and unrelated to treatment) are reported. All other (not including serious) adverse events (related and unrelated to treatment) that exceed a frequency of 5 percent are reported.