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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02301039
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : July 21, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Brief Summary:
The purpose of this study is to determine the efficacy of pembrolizumab in patients with advanced sarcomas.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Bone Sarcoma Drug: Pembrolizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas
Actual Study Start Date : March 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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 will be administered at 200 mg intravenously every 3 weeks
Drug: Pembrolizumab
Other Name: Mk-3475
Experimental: Bone sarcoma
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
Drug: Pembrolizumab
Other Name: Mk-3475

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Assessments will be conducted at 8 weeks, up to 5 years ]
    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

Secondary Outcome Measures :
  1. Number and type of Adverse Events related to pembrolizumab treatment in patients with advanced sarcoma [ Time Frame: 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.

  2. The progression-free survival (PFS) [ Time Frame: 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.

  3. Response rate by immune-related Response Criteria (ir-RC) [ Time Frame: Assessment at 8 weeks, up to 5 years ]
    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

  4. Overall Survival (OS) [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02301039

Contact: SARC Office 734-930-7600

United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Elysse Faye Ballon, Study Coordinator    (323)865-0464   
United States, District of Columbia
Medstar Health Research Institute Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Chris Mathew, CRC    202-877-5371   
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Steven Attia, DO    904-953-7292   
Contact: Clinical Trials Referral Office    507-538-7623      
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Andy Bart, CRC    813-745-1689   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Patty Brink, RN    734-763-1574   
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office    855-776-0015      
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kristina Williams, Manager    314-362-6963   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Tim Barz, Research Project Coordinator    646-888-4371   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Colleen Piechocki, CRC    919-681-4768   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97201
Contact: David Boody-Alter, Senior Research Assistant    503-418-9655   
United States, Pennsylvania
Fox Chase Cancer Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Shawna Redshaw, Lead CRC    412-647-6205   
Contact: Carrie Muniz, Program Manager    412-623-6121   
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
Merck Sharp & Dohme Corp.
Principal Investigator: Hussein Tawbi, MD, PhD The University of Texas MD Anderson Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sarcoma Alliance for Research through Collaboration Identifier: NCT02301039     History of Changes
Other Study ID Numbers: SARC028
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents