Trial Outcomes & Findings for SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas (NCT NCT02301039)

Last Updated: 2020-09-29

Results Overview

The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

144 participants

Primary outcome timeframe

Assessments will be conducted at 8 weeks, up to 5 years

Results posted on

2020-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Soft Tissue Sarcoma Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion Cohort Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
Overall Study STARTED	42	42	60
Overall Study COMPLETED	42	42	60
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Soft Tissue Sarcoma n=42 Participants Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=42 Participants Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion n=60 Participants Patients with the following types of soft tissue sarcoma: Liposarcoma and Pleomorphic sarcoma	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	34 Participants n=7 Participants	38 Participants n=5 Participants	104 Participants n=4 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	2 Participants n=7 Participants	22 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	48 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	43 Participants n=5 Participants	96 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	37 Participants n=7 Participants	53 Participants n=5 Participants	126 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	35 Participants n=7 Participants	51 Participants n=5 Participants	122 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: Assessments will be conducted at 8 weeks, up to 5 years

Population: There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response.

Outcome measures

Outcome measures
Measure	Soft Tissue Sarcoma n=40 Participants Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=40 Participants Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion Cohort n=53 Participants Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
Objective Response Rate	7 Participants	2 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product.

Outcome measures

Outcome measures
Measure	Soft Tissue Sarcoma n=42 Participants Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=42 Participants Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion Cohort n=60 Participants Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient	6 Grade 3 or higher treatment related AEs	9 Grade 3 or higher treatment related AEs	10 Grade 3 or higher treatment related AEs

SECONDARY outcome

Timeframe: up to 5 yrs

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Outcome measures

Outcome measures
Measure	Soft Tissue Sarcoma n=37 Participants Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=39 Participants Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion Cohort n=53 Participants Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
The Progression-free Survival (PFS)	18 weeks Interval 8.0 to 22.0	8 weeks Interval 7.0 to 9.0	8 weeks Interval 7.0 to 13.0

SECONDARY outcome

Timeframe: Assessment at 8 weeks, up to 5 years

Population: There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 52 out of 60 total patients evaluable for response in the soft tissue sarcoma cohort.

Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions

Outcome measures

Outcome measures
Measure	Soft Tissue Sarcoma n=30 Participants Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=30 Participants Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion Cohort n=52 Participants Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
Response Rate by Immune-related Response Criteria (Ir-RC) irCR	1 Participants	0 Participants	2 Participants
Response Rate by Immune-related Response Criteria (Ir-RC) irPR	2 Participants	2 Participants	7 Participants

SECONDARY outcome

Timeframe: up to 5 years

The Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease and are still alive

Outcome measures

Outcome measures
Measure	Soft Tissue Sarcoma n=42 Participants Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=42 Participants Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion Cohort n=60 Participants Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
Overall Survival (OS)	49 weeks Interval 34.0 to 73.0	52 weeks Interval 40.0 to 72.0	57 weeks Interval 33.0 to 86.0

Adverse Events

Soft Tissue Sarcoma

Serious events: 19 serious events

Other events: 40 other events

Deaths: 4 deaths

Bone Sarcoma

Serious events: 15 serious events

Other events: 42 other events

Deaths: 2 deaths

Expansion

Serious events: 17 serious events

Other events: 58 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Research Manager

Sarcoma Alliance for Research Through Collaboration

Phone: 734-930-7600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Soft Tissue Sarcoma n=42 participants at risk Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=42 participants at risk Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion n=60 participants at risk Patients with the following types of soft tissue sarcoma: Undifferentiated pleomorphic sarcoma (UPS) and de-differentiated liposarcoma (LPS). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemmorhage	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Duodenal Perforation	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Infections and infestations Sepsis	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, benign, malignant and unspecified	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	3.3% 2/60 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Laryngeal hemmorrhage	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Nervous system disorders Nervous system disorders, other	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Renal and urinary disorders Acute kidney inury	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Renal and urinary disorders Renal and urinary disorders, other	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Vascular disorders Thromboembolic event	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Vascular disorders Vascular disorders, other	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Cardiac disorders Cardiac disorders, other	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Cardiac disorders Ventricular Tachycardia	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Endocrine disorders Adrenal Insufficiency	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Eye disorders Blurred Vision	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Abdominal pain	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Ascites	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Colonic Obstruction	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Colonic Stenosis	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Ileus	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Pancreatitis	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
General disorders Fatigue	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
General disorders Fever	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
General disorders General Disorders and Administration site conditions	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	5.0% 3/60 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Immune system disorders Immune system disorders, other	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Infections and infestations appendicitis	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Infections and infestations Urinary Tract Infection	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders Dehydration	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder, other	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.

Other adverse events
Measure	Soft Tissue Sarcoma n=42 participants at risk Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab	Bone Sarcoma n=42 participants at risk Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab	Expansion n=60 participants at risk Patients with the following types of soft tissue sarcoma: Undifferentiated pleomorphic sarcoma (UPS) and de-differentiated liposarcoma (LPS). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks
Blood and lymphatic system disorders Blood and Lymphatic Systems Disorder, other	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	3.3% 2/60 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Blood and lymphatic system disorders Febrile Neuropenia	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Blood and lymphatic system disorders Anemia	21.4% 9/42 • Number of events 9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	19.0% 8/42 • Number of events 8 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	35.0% 21/60 • Number of events 21 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Blood and lymphatic system disorders Leukocytosis	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	3.3% 2/60 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Cardiac disorders Cardiac disorders, other	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Cardiac disorders palpitations	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Cardiac disorders Sinus Bradycardia	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Cardiac disorders Sinus Tachycardia	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	6.7% 4/60 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Cardiac disorders Ventricular Tachycardia	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Ear and labyrinth disorders Ear and Labyrinth disorders, other	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Endocrine disorders Endocrine Disorders-other	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Endocrine disorders Hyperparathyroidism	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Endocrine disorders Hyperthyroidism	7.1% 3/42 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	3.3% 2/60 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Endocrine disorders Hypothyroidism	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	11.7% 7/60 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders Abdominal Pain	11.9% 5/42 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	8.3% 5/60 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders constipation	11.9% 5/42 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	14.3% 6/42 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	10.0% 6/60 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders diarrhea	16.7% 7/42 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	10.0% 6/60 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders dry mouth	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	6.7% 4/60 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders flatulance	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders gastrointestinal disorders-other	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	6.7% 4/60 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders non-cardiac chest pain	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Immune system disorders allergic reaction	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Infections and infestations tooth infection	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Gastrointestinal disorders vaginal infection	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Injury, poisoning and procedural complications Bruising	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Injury, poisoning and procedural complications fracture	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	3.3% 2/60 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Investigations activated partial thromboplastin time prolonged	14.3% 6/42 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	16.7% 7/42 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	13.3% 8/60 • Number of events 8 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Investigations Alanine aminotranferase increased	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	11.9% 5/42 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	6.7% 4/60 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Investigations Alkaline Phosphatase increased	9.5% 4/42 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	28.6% 12/42 • Number of events 12 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	11.7% 7/60 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Investigations Aspartate aminotransferase increased	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	16.7% 7/42 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	10.0% 6/60 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Investigations creatinine increased	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	4.8% 2/42 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	8.3% 5/60 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Investigations INR increased	9.5% 4/42 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	9.5% 4/42 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	10.0% 6/60 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Investigations Lymphocyte count decreased	7.1% 3/42 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	14.3% 6/42 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	16.7% 10/60 • Number of events 10 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders dehydration	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	10.0% 6/60 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders hypercalcemia	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/60 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders hyperglycemia	14.3% 6/42 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	7.1% 3/42 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	13.3% 8/60 • Number of events 8 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders hyperkalemia	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	5.0% 3/60 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders hypoalbumenia	7.1% 3/42 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	11.9% 5/42 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	13.3% 8/60 • Number of events 8 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders hypocalcemia	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	2.4% 1/42 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	6.7% 4/60 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Metabolism and nutrition disorders hypokalemia	0.00% 0/42 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	9.5% 4/42 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.	1.7% 1/60 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.