A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma
|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.|
|ClinicalTrials.gov Identifier: NCT03069378|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Talimogene Laherparepvec (T-VEC) Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|Official Title:||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|
|Actual Study Start Date :||March 3, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Talimogene Laherparepvec (T-VEC) Administered with Pembrolizu
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Drug: Talimogene Laherparepvec (T-VEC)
Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
- best objective response rate [ Time Frame: 24 weeks ](complete response + partial response) RECIST 1.1
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 ClinicalTrials.gov identifier (NCT number): NCT03069378
|Contact: Ciara Kelly, MBBCh BAOfirstname.lastname@example.org|
|Contact: William Tap, MD||646-888-4163|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Ciara Kelly, MBBCh BAO 646-888-4312|
|Principal Investigator: Ciara Kelly, MBBCh BAO|
|Principal Investigator:||Ciara Kelly, MBBCh BAO||Memorial Sloan Kettering Cancer Center|