A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma
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ClinicalTrials.gov Identifier: NCT03069378 |
Recruitment Status :
Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : November 21, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | February 27, 2017 | ||||
First Posted Date ICMJE | March 3, 2017 | ||||
Last Update Posted Date | November 21, 2023 | ||||
Actual Study Start Date ICMJE | March 3, 2017 | ||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
best objective response rate [ Time Frame: 24 weeks ] (complete response + partial response) RECIST 1.1
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma | ||||
Official Title ICMJE | A Phase II Study of Talimogene Laherparepvec (T-VEC) Administered Concurrently With the Anti-PD1 Monoclonal Antibody Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma | ||||
Brief Summary | The purpose of this study is to determine how well the combination of therapy of talimogene laherparepvec (T-VEC) and pembrolizumab works in the treatment of patients with sarcoma. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: This is a single-center, phase II study to evaluate the efficacy of the oncolytic herpes virus talimogene laherparepvec, given in combination with pembrolizumab for patients with metastatic and/or locally advanced sarcomas. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Talimogene Laherparepvec (T-VEC) Administered with Pembrolizu
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Interventions:
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Publications * |
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* 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 | Active, not recruiting | ||||
Actual Enrollment ICMJE |
41 | ||||
Original Estimated Enrollment ICMJE |
26 | ||||
Estimated Study Completion Date ICMJE | March 2025 | ||||
Estimated Primary Completion Date | March 2025 (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 | 18 Years and older (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 | NCT03069378 | ||||
Other Study ID Numbers ICMJE | 16-1534 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Memorial Sloan Kettering Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||
Verification Date | November 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |