Tabelecleucel in Combination With Pembrolizumab in Subjects With EBV+ Nasopharyngeal Carcinoma (ATA129-NPC-202)
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|ClinicalTrials.gov Identifier: NCT03769467|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma Nasopharyngeal Neoplasms Epstein-Barr Virus Infections Epstein-Barr Viraemia||Biological: tabelecleucel Biological: pembrolizumab||Phase 1 Phase 2|
This is a multicenter, open-label, single-arm phase 1b/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic EBV+ NPC.
Tabelecleucel will be selected for each subject from the bank of available tabelecleucel cell products based on matching ≥ 2 human leukocyte antigen (HLA) alleles, at least one of which is a restricting HLA allele, shared between the tabelecleucel donor and the subject's EBV+ NPC. Sites will provide high resolution HLA typing of the subject and other information as required by the protocol.
Phase 1b will identify the maximum tolerated dose (MTD) and characterize the dose limiting toxicity (DLT) for tabelecleucel in combination with pembrolizumab in up to 24 subjects. In the absence of an MTD, the recommended Phase 2 dose will be identified. Phase 2 will evaluate the safety and efficacy of the combination in 36 subjects at the recommended dose level from Phase 1b.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase 1B/2 Study to Evaluate the Safety and Efficacy of Tabelecleucel in Combination With Pembrolizumab in Subjects With Platinum-pretreated, Recurrent/Metastatic Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma|
|Actual Study Start Date :||November 28, 2018|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: tabelecleucel in combination with pembrolizumab
Tabelecleucel will be administered initially to 12 subjects at a dose of 2 x 10^6 cells/kg intravenously (IV) on Day 1, Day 8, and 15 of a 21-day cycle. Pembrolizumab will be administered to adult subjects at 200 mg or to pediatric subjects (12 to < 18 years of age) at 2 mg/kg IV every 3 weeks.
Tabelecleucel is an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
pembrolizumab IV infusion
Other Name: MK-3475
- Phase 1b: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Approximately 1 month ]
- Phase 1b: Maximum tolerated dose (MTD) [ Time Frame: Approximately 1 year ]
- Phase 1b: Recommended phase 2 dose (RP2D) of tabelecleucel in combination with pembrolizumab [ Time Frame: Approximately 1 year ]
- Objective response rate (ORR) [ Time Frame: Approximately 38 months ]The ORR is defined as complete response [CR] or partial response [PR] confirmed ≥ 28 days from the initial response assessment showing a response.
- Complete Response (CR) rate [ Time Frame: Approximately 38 months ]
- Duration of response (DOR) [ Time Frame: Approximately 38 months ]DOR is defined as CR + PR
- Progression-free survival (PFS) [ Time Frame: Approximately 38 months ]
- Overall Survival (OS) [ Time Frame: Approximately 38 months ]
- Immune response rate (iRR) [ Time Frame: Approximately 38 months ]iRR is defined as immune CR [iCR] + immune PR [iPR] rate
- Duration of immune response (DOiR) [ Time Frame: Approximately 38 months ]
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): NCT03769467
|Contact: Atara Biotherapeutics||(805) email@example.com|
|Contact: Atara Biotherapeutics|
|United States, Missouri|
|Washington University School of Medicine (Adults and Pediatrics)||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Douglas Adkins, MD 314-747-8475 firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania (Adults and Pediatrics)||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Joshua Bauml, MD 215-614-1858 Joshua.Bauml@uphs.upenn.edu|
|Study Director:||Wen Shi, MD, PhD||Atara Biotherapeutics|
|Study Director:||Akshay Sudhindra, MD||Atara Biotherapeutics|