Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
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|ClinicalTrials.gov Identifier: NCT03769467|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma Nasopharyngeal Neoplasms Epstein-Barr Virus Infections Epstein-Barr Viraemia Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)||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 ]
- 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 ]
- 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
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Stanford Hospital and Clinics|
|Palo Alto, California, United States, 94305|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, New Jersey|
|Atlantic Health System / Morristown Medical Center|
|Morristown, New Jersey, United States, 07962|
|United States, New York|
|Laura & Isaac Perlmutter Cancer Center at NYU Langone Health|
|New York, New York, United States, 10016|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|University of Pennsylvania (Adults and Pediatrics)|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Director:||Willis Navarro, MD||Atara Biotherapeutics|