eligibility Criteria: Inclusion Criteria: * Age ≥ 18 years (Age ≥ 12 years for patients with bone sarcomas). * Histologically confirmed diagnosis of unresectable, recurrent, and/or metastatic high grade soft-tissue or bone sarcoma of one of the following subtypes: soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma), and bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]). * ECOG Performance Status of 0 or 1. * At least one site of measurable disease on CT/MRI scans as defined by RECIST 1.1. Baseline imaging must be performed within 30 days of dosing. * At least one site of accessible disease for pre- and post-treatment core biopsies for at least 20 patients per arm on the expansion cohorts. * Patients may have received 1-3 prior systemic therapies in the metastatic setting. * Adequate organ function within 14 days of dosing * Must be willing to provide and have available archival tissue for PD-L1 testing. * Written, voluntary informed consent. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study. * Effective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence. * Life expectancy of \>12 weeks. * Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to screening, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of pembrolizumab. Exclusion Criteria: * Prior systemic therapy targeting PD-1: PD-L1 axis. * Patients who are curable by conventional multidisciplinary management. * Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol. * Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks prior to screening or who have not recovered adequately from side effects of such therapy. * Patients who have active infections requiring therapy. * Patients that are known to be positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive), or Hepatitis C (HCV RNA \[qualitative\] is detected); patients with negative Hepatitis C antibody testing may not need RNA testing. * Patients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial. * Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames: * Patients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study. * Women who are pregnant or nursing/breastfeeding. * Known hypersensitivity to pembrolizumab or another mAb. * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Patients with untreated central nervous system disease. Patients with controlled treated CNS lesions who have undergone surgery or stereotactic radiosurgery and stable for 4 weeks are eligible. * Inability to comply with protocol required procedures. * Patients with medical conditions that require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication. However, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening. * Patients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis). * Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment.
healthy Volunteers: false
minimum Age: 12 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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
intervention Names
Drug: Pembrolizumab
label
Soft tissue sarcoma
type
EXPERIMENTAL
description
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
intervention Names
Drug: Pembrolizumab
label
Bone sarcoma
type
EXPERIMENTAL
description
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
intervention Names
Drug: Pembrolizumab
label
Expansion
type
EXPERIMENTAL

interventions

arm Group Labels
Bone sarcoma
Expansion
Soft tissue sarcoma
name
Pembrolizumab
other Names
Mk-3475
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 144
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Objective Response Rate
time Frame
Assessments will be conducted at 8 weeks, up to 5 years

secondary Outcomes

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.
measure
Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient
time Frame
Up to 5 years
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.
measure
The Progression-free Survival (PFS)
time Frame
up to 5 yrs
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
measure
Response Rate by Immune-related Response Criteria (Ir-RC)
time Frame
Assessment at 8 weeks, up to 5 years
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
measure
Overall Survival (OS)
time Frame
up to 5 years

Full study description

brief Summary: The purpose of this study is to determine the efficacy of pembrolizumab in patients with advanced sarcomas.
detailed Description: This is a multi-institutional phase II study of pembrolizumab in patients with advanced sarcomas. This study will have two treatment groups, one group for patients with soft tissue sarcoma and one group for patients with bone sarcoma. Initial enrollment for this study included a total of 86 patients with soft tissue sarcoma and bone sarcomas. In the expansion portion, there will be an additional 30 patients with undifferentiated pleomorphic sarcoma (UPS) and 30 patients with dedifferentiated or other high grade liposarcoma (LPS) enrolled into the study.

Source references

references

citation
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.
pmid
28988646
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-7ad944f6deaf1f5cd6122126
edge id
nct-edge-9023bee908a1657c495a
requested nct id
NCT02301039
primary nct id
NCT02301039
source kind
nci_explicit_reference_or_link
source url
https://www.cancer.gov/types/soft-tissue-sarcoma/hp/adult-soft-tissue-treatment-pdq
source record id
Source null
source file sha256
9465d9a72734c9bd3e3db859fe4c8f227bb30b5f70dc6864a0d40359b8ea84d3
payload sha256
560861385079f8617ddddd5accfee06d067b2396cb18ca2ed0547f9dc5b3382d
payload
clinical indication matching status
not_inferred
end exclusive
true
id
nct-edge-9023bee908a1657c495a
link basis
explicit_NCT_identifier_in_acquired_source
nct id
NCT02301039
occurrences
context exact
lass="pdq-content-list"><ol id="_2057"><li>The phase II Sarcoma Alliance for Research through Collaboration trial (<a href="https://clinicaltrials.gov/ct2/show/NCT02301039" title="https://clinicaltrials.gov/ct2/show/NCT02301039">SARC028</a> [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissu
end
228240
exact text
NCT02301039
start
228229
context exact
Sarcoma Alliance for Research through Collaboration trial (<a href="https://clinicaltrials.gov/ct2/show/NCT02301039" title="https://clinicaltrials.gov/ct2/show/NCT02301039">SARC028</a> [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma
end
228296
exact text
NCT02301039
start
228285
context exact
rch through Collaboration trial (<a href="https://clinicaltrials.gov/ct2/show/NCT02301039" title="https://clinicaltrials.gov/ct2/show/NCT02301039">SARC028</a> [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomy
end
228322
exact text
NCT02301039
start
228311
offset unit
unicode_code_points
source file
/tmp/cancer-full-research/nci/raw/fc630f597981bfeac3.html
source file sha256
9465d9a72734c9bd3e3db859fe4c8f227bb30b5f70dc6864a0d40359b8ea84d3
source json pointer
Source null
source kind
nci_explicit_reference_or_link
source record id
Source null
source retrieved at
2026-09-09T23:22:19.112058+00:00
source string basis
UTF-8_text_with_universal_newline_translation
source string sha256
7192ca8ed54c92ff6b85c1b874bce0b65c4fd0808e206dcdb389df3def53014a
source title
Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: February 21, 2025
datetime
2025-02-21T12:00:00Z
display
February 21, 2025
source url
https://www.cancer.gov/types/soft-tissue-sarcoma/hp/adult-soft-tissue-treatment-pdq

Preserved source evidence · Not medical advice