Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
NCT03769467 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-11-14
Summary
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 Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC).
Conditions
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Epstein-Barr Virus Infections
- Epstein-Barr Viraemia
- Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
Interventions
- BIOLOGICAL
-
Tabelecleucel is an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
- BIOLOGICAL
-
pembrolizumab IV infusion
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Aditi Mehta, DO · Atara Biotherapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-19
- Primary Completion
- 2021-08-19
- Completion
- 2021-08-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
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