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:
Sarcoma Alliance for Research through Collaboration
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration
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Tracking Information | ||||
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First Submitted Date ICMJE | November 17, 2014 | |||
First Posted Date ICMJE | November 25, 2014 | |||
Results First Submitted Date ICMJE | July 8, 2020 | |||
Results First Posted Date ICMJE | September 29, 2020 | |||
Last Update Posted Date | September 29, 2020 | |||
Actual Study Start Date ICMJE | March 2015 | |||
Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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, 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.
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Original Primary Outcome Measures ICMJE |
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
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas | |||
Official Title ICMJE | SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Pembrolizumab
Other Name: Mk-3475
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
144 | |||
Original Estimated Enrollment ICMJE |
80 | |||
Actual Study Completion Date ICMJE | July 1, 2020 | |||
Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02301039 | |||
Other Study ID Numbers ICMJE | SARC028 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Sarcoma Alliance for Research through Collaboration | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Sarcoma Alliance for Research through Collaboration | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Merck Sharp & Dohme LLC | |||
Investigators ICMJE |
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PRS Account | Sarcoma Alliance for Research through Collaboration | |||
Verification Date | September 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |