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

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ClinicalTrials.gov Identifier: NCT02301039

Recruitment Status : Completed

First Posted : November 25, 2014

Results First Posted : September 29, 2020

Last Update Posted : September 29, 2020

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Sponsor:

Collaborator:

Merck Sharp & Dohme LLC

Information provided by (Responsible Party):

Sarcoma Alliance for Research through Collaboration

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Soft Tissue Sarcoma Bone Sarcoma
Intervention	Drug: Pembrolizumab
Enrollment	144

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Soft Tissue Sarcoma	Bone Sarcoma	Expansion Cohort
Arm/Group Description	Patients with the following types o...	Patients with the following types o...	Patients with the following types o...
Arm/Group Description	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	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	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
Period Title: Overall Study
Started	42	42	60
Completed	42	42	60
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Soft Tissue Sarcoma	Bone Sarcoma	Expansion	Total
Arm/Group Description		Patients with the following types o...	Patients with the following types o...	Patients with the following types o...	Total of all reporting groups
Arm/Group Description		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	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	Patients with the following types of soft tissue sarcoma: Liposarcoma and Pleomorphic sarcoma	Total of all reporting groups
Overall Number of Baseline Participants		42	42	60	144
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	60 participants	144 participants
	<=18 years	1 2.4%	6 14.3%	0 0.0%	7 4.9%
	Between 18 and 65 years	32 76.2%	34 81.0%	38 63.3%	104 72.2%
	>=65 years	9 21.4%	2 4.8%	22 36.7%	33 22.9%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	60 participants	144 participants
	Female	15 35.7%	16 38.1%	17 28.3%	48 33.3%
	Male	27 64.3%	26 61.9%	43 71.7%	96 66.7%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	60 participants	144 participants
	Hispanic or Latino	2 4.8%	1 2.4%	5 8.3%	8 5.6%
	Not Hispanic or Latino	36 85.7%	37 88.1%	53 88.3%	126 87.5%
	Unknown or Not Reported	4 9.5%	4 9.5%	2 3.3%	10 6.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	60 participants	144 participants
	American Indian or Alaska Native	0 0.0%	1 2.4%	0 0.0%	1 0.7%
	Asian	2 4.8%	1 2.4%	1 1.7%	4 2.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	3 7.1%	2 4.8%	4 6.7%	9 6.3%
	White	36 85.7%	35 83.3%	51 85.0%	122 84.7%
	More than one race	0 0.0%	1 2.4%	0 0.0%	1 0.7%
	Unknown or Not Reported	1 2.4%	2 4.8%	4 6.7%	7 4.9%

Outcome Measures

1.Primary Outcome


Title	Objective Response Rate
Description	The Objective Response Rate (ORR) is the percentage of patient's tumor...
Description	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.
Time Frame	Assessments will be conducted at 8 weeks, up to 5 years

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Soft Tissue Sarcoma	Bone Sarcoma	Expansion Cohort
Arm/Group Description:	Patients with the following types o...	Patients with the following types o...	Patients with the following types o...
Arm/Group Description:	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	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	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 Number of Participants Analyzed	40	40	53
Measure Type: Count of Participants Unit of Measure: Participants
	7 17.5%	2 5.0%	7 13.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Soft Tissue Sarcoma
	Comments	An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
	Type of Statistical Test	Superiority
	Comments	An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.

Method of Estimation	Estimation Parameter	Binomial estimate of response rate of PR
	Estimated Value	17.5
	Confidence Interval	(2-Sided) 95% 7.3 to 32.8
	Estimation Comments	Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Bone Sarcoma
	Comments	An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Binomial estimate of response rate of PR
	Estimated Value	5.0
	Confidence Interval	(2-Sided) 95% 1.0 to 16.9
	Estimation Comments	Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Expansion Cohort
	Comments	An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Binomial estimate of response rate of PR
	Estimated Value	13.0
	Confidence Interval	(2-Sided) 95% 5.5 to 25.3
	Estimation Comments	Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients

2.Secondary Outcome


Title	Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient
Description	Related Adverse Event is any unfavorable and unintended sign (includin...
Description	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.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Soft Tissue Sarcoma	Bone Sarcoma	Expansion Cohort
Arm/Group Description:	Patients with the following types o...	Patients with the following types o...	Patients with the following types o...
Arm/Group Description:	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	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	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 Number of Participants Analyzed	42	42	60
Measure Type: Number Unit of Measure: Grade 3 or higher treatment related AEs
	6	9	10

3.Secondary Outcome


Title	The Progression-free Survival (PFS)
Description	The progression-free survival is the length of time during and after t...
Description	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.
Time Frame	up to 5 yrs

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Soft Tissue Sarcoma	Bone Sarcoma	Expansion Cohort
Arm/Group Description:	Patients with the following types o...	Patients with the following types o...	Patients with the following types o...
Arm/Group Description:	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	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	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 Number of Participants Analyzed	37	39	53
Median (95% Confidence Interval) Unit of Measure: weeks
	18 (8 to 22)	8 (7 to 9)	8 (7 to 13)

4.Secondary Outcome


Title	Response Rate by Immune-related Response Criteria (Ir-RC)
Description	Immune related response criteria was developed to adequately assess tu...
Description	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
Time Frame	Assessment at 8 weeks, up to 5 years

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Soft Tissue Sarcoma	Bone Sarcoma	Expansion Cohort
Arm/Group Description:	Patients with the following types o...	Patients with the following types o...	Patients with the following types o...
Arm/Group Description:	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	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	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 Number of Participants Analyzed	30	30	52
Measure Type: Count of Participants Unit of Measure: Participants
irCR	1 3.3%	0 0.0%	2 3.8%
irPR	2 6.7%	2 6.7%	7 13.5%

5.Secondary Outcome


Title	Overall Survival (OS)
Description	The Overall Survival is the length of time from either the date of dia...
Description	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
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Soft Tissue Sarcoma	Bone Sarcoma	Expansion Cohort
Arm/Group Description:	Patients with the following types o...	Patients with the following types o...	Patients with the following types o...
Arm/Group Description:	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	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	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 Number of Participants Analyzed	42	42	60
Median (95% Confidence Interval) Unit of Measure: weeks
	49 (34 to 73)	52 (40 to 72)	57 (33 to 86)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Soft Tissue Sarcoma		Bone Sarcoma		Expansion
Arm/Group Description	Patients with the following types o...		Patients with the following types o...		Patients with the following types o...
Arm/Group Description	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		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		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
All-Cause Mortality
	Soft Tissue Sarcoma		Bone Sarcoma		Expansion
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	4/42 (9.52%)		2/42 (4.76%)		2/60 (3.33%)
Serious Adverse Events Serious Adverse Events
	Soft Tissue Sarcoma		Bone Sarcoma		Expansion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/42 (45.24%)		15/42 (35.71%)		17/60 (28.33%)
Cardiac disorders
Cardiac disorders, other ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Ventricular Tachycardia ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Endocrine disorders
Adrenal Insufficiency ^* 1	2/42 (4.76%)	2	0/42 (0.00%)	0	0/60 (0.00%)	0
Eye disorders
Blurred Vision ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Gastrointestinal disorders
Duodenal Perforation ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Abdominal pain ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
Ascites ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Colonic Obstruction ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Colonic Stenosis ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Ileus ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Pancreatitis ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
General disorders
Fatigue ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Fever ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
General Disorders and Administration site conditions ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	3/60 (5.00%)	3
Immune system disorders
Immune system disorders, other ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Infections and infestations
Sepsis ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
appendicitis ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Urinary Tract Infection ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Metabolism and nutrition disorders
Dehydration ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Bone Pain ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Musculoskeletal and connective tissue disorder, other ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Myositis ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, benign, malignant and unspecified ^* 1	2/42 (4.76%)	2	1/42 (2.38%)	1	2/60 (3.33%)	2
Nervous system disorders
Nervous system disorders, other ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Renal and urinary disorders
Acute kidney inury ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Renal and urinary disorders, other ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	0/60 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemmorhage ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Dyspnea ^* 1	2/42 (4.76%)	2	1/42 (2.38%)	1	1/60 (1.67%)	1
Hypoxia ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Laryngeal hemmorrhage ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Pleural Effusion ^* 1	0/42 (0.00%)	0	2/42 (4.76%)	2	1/60 (1.67%)	1
Pneumonitis ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Vascular disorders
Thromboembolic event ^* 1	2/42 (4.76%)	2	0/42 (0.00%)	0	1/60 (1.67%)	1
Vascular disorders, other ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
1 Term from vocabulary, CTCAE (4.0) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Soft Tissue Sarcoma		Bone Sarcoma		Expansion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/42 (95.24%)		42/42 (100.00%)		58/60 (96.67%)
Blood and lymphatic system disorders
Anemia ^* 1	9/42 (21.43%)	9	8/42 (19.05%)	8	21/60 (35.00%)	21
Blood and Lymphatic Systems Disorder, other ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	2/60 (3.33%)	2
Febrile Neuropenia ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
Leukocytosis ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	2/60 (3.33%)	2
Cardiac disorders
Cardiac disorders, other ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
palpitations ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Sinus Bradycardia ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Sinus Tachycardia ^* 1	2/42 (4.76%)	2	2/42 (4.76%)	2	4/60 (6.67%)	4
Ventricular Tachycardia ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Ear and labyrinth disorders
Ear and Labyrinth disorders, other ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Endocrine disorders
Endocrine Disorders-other ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Hyperparathyroidism ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Hyperthyroidism ^* 1	3/42 (7.14%)	3	2/42 (4.76%)	2	2/60 (3.33%)	2
Hypothyroidism ^* 1	2/42 (4.76%)	2	2/42 (4.76%)	2	7/60 (11.67%)	7
Eye disorders
Blurred vision ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
photophobia ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Gastrointestinal disorders
Abdominal Pain ^* 1	5/42 (11.90%)	5	1/42 (2.38%)	1	5/60 (8.33%)	5
constipation ^* 1	5/42 (11.90%)	5	6/42 (14.29%)	6	6/60 (10.00%)	6
diarrhea ^* 1	7/42 (16.67%)	7	2/42 (4.76%)	2	6/60 (10.00%)	6
dry mouth ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	4/60 (6.67%)	4
flatulance ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
gastrointestinal disorders-other ^* 1	2/42 (4.76%)	2	0/42 (0.00%)	0	4/60 (6.67%)	4
non-cardiac chest pain ^* 1	0/42 (0.00%)	0	2/42 (4.76%)	2	0/60 (0.00%)	0
vaginal infection ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Dental caries ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
Dyspepsia ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
Gastric ulcer ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
Gastritis ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
gastroesophogeal reflux ^* 1	2/42 (4.76%)	2	0/42 (0.00%)	0	0/60 (0.00%)	0
Mucositis oral ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Nausea ^* 1	10/42 (23.81%)	10	3/42 (7.14%)	3	9/60 (15.00%)	9
rectal pain ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Vomiting ^* 1	4/42 (9.52%)	4	1/42 (2.38%)	1	4/60 (6.67%)	4
General disorders
chills ^* 1	0/42 (0.00%)	0	2/42 (4.76%)	2	5/60 (8.33%)	5
Edema limbs ^* 1	3/42 (7.14%)	3	2/42 (4.76%)	2	6/60 (10.00%)	6
Fatigue ^* 1	2/42 (4.76%)	2	1/42 (2.38%)	1	1/60 (1.67%)	1
flu like symptoms ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
general disorders-other ^* 1	1/42 (2.38%)	1	3/42 (7.14%)	3	5/60 (8.33%)	5
Hypothermia ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
localized edema ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	2/60 (3.33%)	2
malaise ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
Pain ^* 1	1/42 (2.38%)	1	2/42 (4.76%)	2	0/60 (0.00%)	0
Immune system disorders
allergic reaction ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
serum sickness ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Infections and infestations
tooth infection ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
infections and infestations-other ^* 1	2/42 (4.76%)	2	1/42 (2.38%)	1	0/60 (0.00%)	0
papulopustular rash ^* 1	2/42 (4.76%)	2	1/42 (2.38%)	1	0/60 (0.00%)	0
skin infection ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
upper respiratory infection ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	4/60 (6.67%)	4
Injury, poisoning and procedural complications
Bruising ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
fracture ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	2/60 (3.33%)	2
Investigations
activated partial thromboplastin time prolonged ^* 1	6/42 (14.29%)	6	7/42 (16.67%)	7	8/60 (13.33%)	8
Alanine aminotranferase increased ^* 1	1/42 (2.38%)	1	5/42 (11.90%)	5	4/60 (6.67%)	4
Alkaline Phosphatase increased ^* 1	4/42 (9.52%)	4	12/42 (28.57%)	12	7/60 (11.67%)	7
Aspartate aminotransferase increased ^* 1	0/42 (0.00%)	0	7/42 (16.67%)	7	6/60 (10.00%)	6
creatinine increased ^* 1	2/42 (4.76%)	2	2/42 (4.76%)	2	5/60 (8.33%)	5
INR increased ^* 1	4/42 (9.52%)	4	4/42 (9.52%)	4	6/60 (10.00%)	6
Lymphocyte count decreased ^* 1	3/42 (7.14%)	3	6/42 (14.29%)	6	10/60 (16.67%)	10
Blood bilirubin increased ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	1/60 (1.67%)	1
CPK increased ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	2/60 (3.33%)	2
investigations-other ^* 1	1/42 (2.38%)	1	3/42 (7.14%)	3	1/60 (1.67%)	1
lymphocyte count increased ^* 1	1/42 (2.38%)	1	3/42 (7.14%)	3	1/60 (1.67%)	1
neutrophil count decreased ^* 1	0/42 (0.00%)	0	2/42 (4.76%)	2	1/60 (1.67%)	1
platelet count decreased ^* 1	1/42 (2.38%)	1	3/42 (7.14%)	3	3/60 (5.00%)	3
weight loss ^* 1	1/42 (2.38%)	1	4/42 (9.52%)	4	0/60 (0.00%)	0
white blood cell decreased ^* 1	1/42 (2.38%)	1	4/42 (9.52%)	4	0/60 (0.00%)	0
Metabolism and nutrition disorders
dehydration ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	6/60 (10.00%)	6
hypercalcemia ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	0/60 (0.00%)	0
hyperglycemia ^* 1	6/42 (14.29%)	6	3/42 (7.14%)	3	8/60 (13.33%)	8
hyperkalemia ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	3/60 (5.00%)	3
hypoalbumenia ^* 1	3/42 (7.14%)	3	5/42 (11.90%)	5	8/60 (13.33%)	8
hypocalcemia ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	4/60 (6.67%)	4
hypokalemia ^* 1	0/42 (0.00%)	0	4/42 (9.52%)	4	1/60 (1.67%)	1
hyponatremia ^* 1	5/42 (11.90%)	5	8/42 (19.05%)	8	8/60 (13.33%)	8
anorexia ^* 1	6/42 (14.29%)	6	2/42 (4.76%)	2	8/60 (13.33%)	8
Musculoskeletal and connective tissue disorders
arthralgia ^* 1	3/42 (7.14%)	3	0/42 (0.00%)	0	3/60 (5.00%)	3
back pain ^* 1	7/42 (16.67%)	7	1/42 (2.38%)	1	8/60 (13.33%)	8
chest wall pain ^* 1	3/42 (7.14%)	3	3/42 (7.14%)	3	1/60 (1.67%)	1
musculoskeletal and connective tissue disorder-other ^* 1	2/42 (4.76%)	2	2/42 (4.76%)	2	7/60 (11.67%)	7
pain in extremity ^* 1	3/42 (7.14%)	3	4/42 (9.52%)	4	6/60 (10.00%)	6
bone pain ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	2/60 (3.33%)	2
buttock pain ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
flank pain ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
generalized muscle weakness ^* 1	2/42 (4.76%)	2	0/42 (0.00%)	0	1/60 (1.67%)	1
joint effusion ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
joint range of motion decreased ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
myalgia ^* 1	4/42 (9.52%)	4	1/42 (2.38%)	1	2/60 (3.33%)	2
neck pain ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	1/60 (1.67%)	1
soft tissue necrosis upper limb ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor pain ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	2/60 (3.33%)	2
neoplasms, benign, malignant, and unspecified ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
Nervous system disorders
dizziness ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
headache ^* 1	4/42 (9.52%)	4	1/42 (2.38%)	1	2/60 (3.33%)	2
nervous system disorders, other ^* 1	0/42 (0.00%)	0	2/42 (4.76%)	2	0/60 (0.00%)	0
neuralgia ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
dysesthesia ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
dysgeusia ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Paresthesia ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
peripheral sensory neuropathy ^* 1	3/42 (7.14%)	3	0/42 (0.00%)	0	1/60 (1.67%)	1
presyncope ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Psychiatric disorders
confusion ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
insomnia ^* 1	2/42 (4.76%)	2	4/42 (9.52%)	4	0/60 (0.00%)	0
anxiety ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	3/60 (5.00%)	3
depression ^* 1	2/42 (4.76%)	2	0/42 (0.00%)	0	1/60 (1.67%)	1
psychiatric disorders-other ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
suicidal ideation ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	0/60 (0.00%)	0
Renal and urinary disorders
Proteinuria ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
URINARY URGENCY ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
Respiratory, thoracic and mediastinal disorders
cough ^* 1	9/42 (21.43%)	9	7/42 (16.67%)	7	7/60 (11.67%)	7
dyspnea ^* 1	6/42 (14.29%)	6	4/42 (9.52%)	4	5/60 (8.33%)	5
Laryngeal hemmorhage ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
pleural effusion ^* 1	2/42 (4.76%)	2	1/42 (2.38%)	1	1/60 (1.67%)	1
Postnasal drip ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	0/60 (0.00%)	0
respiratory, thoracic, and mediastinal disorders, other ^* 1	4/42 (9.52%)	4	1/42 (2.38%)	1	1/60 (1.67%)	1
allergic rhinitis ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
pneumonitis ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	0/60 (0.00%)	0
productive cough ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
sore throat ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	1/60 (1.67%)	1
Skin and subcutaneous tissue disorders
erythmea multiforme ^* 1	1/42 (2.38%)	1	0/42 (0.00%)	0	1/60 (1.67%)	1
Pruritis ^* 1	3/42 (7.14%)	3	1/42 (2.38%)	1	6/60 (10.00%)	6
rash maculo-papular ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	7/60 (11.67%)	7
rash acneiform ^* 1	1/42 (2.38%)	1	1/42 (2.38%)	1	1/60 (1.67%)	1
skin and subcutaneous tissue disorders ^* 1	5/42 (11.90%)	5	1/42 (2.38%)	1	3/60 (5.00%)	3
Vascular disorders
Hot flashes ^* 1	0/42 (0.00%)	0	1/42 (2.38%)	1	1/60 (1.67%)	1
Hypertension ^* 1	0/42 (0.00%)	0	2/42 (4.76%)	2	8/60 (13.33%)	8
Hypotension ^* 1	0/42 (0.00%)	0	0/42 (0.00%)	0	1/60 (1.67%)	1
1 Term from vocabulary, CTCAE (4.0) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Research Manager
Organization:	Sarcoma Alliance for Research Through Collaboration
Phone:	734-930-7600
EMail:	sarc@sarctrials.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tawbi HA, Burgess M, Bolejack V, Van Tine BA, Schuetze SM, Hu J, D'Angelo S, Attia S, Riedel RF, Priebat DA, Movva S, Davis LE, Okuno SH, Reed DR, Crowley J, Butterfield LH, Salazar R, Rodriguez-Canales J, Lazar AJ, Wistuba II, Baker LH, Maki RG, Reinke D, Patel S. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol. 2017 Nov;18(11):1493-1501. doi: 10.1016/S1470-2045(17)30624-1. Epub 2017 Oct 4. Erratum In: Lancet Oncol. 2017 Dec;18(12 ):e711. Lancet Oncol. 2018 Jan;19(1):e8.

Layout table for additonal information

Responsible Party:	Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:	NCT02301039
Other Study ID Numbers:	SARC028
First Submitted:	November 17, 2014
First Posted:	November 25, 2014
Results First Submitted:	July 8, 2020
Results First Posted:	September 29, 2020
Last Update Posted:	September 29, 2020

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