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Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Subjects will receive IV infusions of tabelecleucel at 2 × 10\^6 T-cells/kg on Days 1, 8, and 15; and an IV infusion of pembrolizumab at 200 mg for adults or 2 mg/kg for adolescents on Day 1 of each 21-day cycle (at least 2 cycles or up to 4 cycles). For Cohort 1, if there is a dose-limiting toxicity, the dose of tabelecleucel will be reduced to 1 x 10\^6 cells/kg and pembrolizumab will continue to be administered as above. Otherwise, all subjects in Cohort 1 will receive tabelecleucel at 2 x 10\^6 cells/kg/dose and pembrolizumab as above. Subjects in Cohort 2 will receive the recommended Phase 2 dose of tabelecleucel per the SDRC and pembrolizumab as above.

Tabelecleucel is an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

tabelecleucel

pembrolizumab

Willis Navarro, MD

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).

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 (RP2D) 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.

Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)

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

The ORR is defined as complete response (CR) or partial response (PR) confirmed \>= 28 days from the initial response assessment showing a response.

Merck Sharp & Dohme LLC

Atara Biotherapeutics

Radiotherapy, intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks ) will be administered as an intravenous infusion over 60 minutes.

Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks) will be administered as an intravenous infusion over 60 minutes.

Tolipalimab

intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks

Reirradiation

Ming-Yuan Chen, MD,PhD

The purpose of this study is to evaluate the efficacy and safety of intensity-modulated radiation therapy combined with toripalimab in patients with the unresectable locally recurrent nasopharyngeal carcinoma.

This is an open-label ,single center ,non-randomized, single arm exploratory study. All eligible patients presented with non-keratinizing NPC and stage rT0-4N1-3M0 /rT2-4N0M0 are assigned to receive IMRT combined with toripalimab.

IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma.

A Single Center 、Single Arm Phase I/II Clinical Trial of Intensity-modulated Radiotherapy Combined With Toripalimab in the Treating of Unresectable Locally Recurrent Nasopharyngeal Carcinoma.

Progression-Free Survival is defined as time interval from recruitment to tumor progression or censoring.

Overall Survival is defined as time interval from recruitment to all-caused death or censoring.

Adverse events (AE), Serious Adverse Event(SAE)

Sun Yat-sen University

principal investigator

Gemcitabine

Fluorouracil

Cisplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

gemcitabine and cisplatin

Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

cisplatin and fluorouracil

Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor

IMRT

IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

cisplatin

The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC ) patients.

Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil) induction chemotherapy combined with concurrent chemoradiotherapy. Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free survival (LRRFS), initial response rates after treatments, toxic effects and quality of life (QoL).

GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma：a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangdong Provincial People's Hospital

First Affiliated Hospital, Sun Yat-Sen University

Principal Investigator

Nimotuzumab

nimotuzumab 200mg/week in concurrent with IMRT

cisplatin 40mg/m2/week in concurrent with IMRT

nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

Rui-Hua Xu, MD,PhD

This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.

Scheme:

Eligible stage II and III NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

- Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT

- Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)	NCT03769467	Nasopharyngeal ... Nasopharyngeal ... Epstein-Barr Vi... Epstein-Barr Vi... Epstein-Barr Vi...	tabelecleucel pembrolizumab	12 Years -	Atara Biotherapeutics
IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma.	NCT03854838	Nasopharyngeal ... Nasopharyngeal ... Nasopharyngeal ... Head and Neck N...	Tolipalimab Reirradiation	18 Years - 65 Years	Sun Yat-sen University
GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma	NCT03840421	Nasopharyngeal ... Nasopharyngeal ... Nasopharyngeal ... Head and Neck N...	gemcitabine and... cisplatin and f... IMRT cisplatin	18 Years - 65 Years	Sun Yat-sen University
Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma	NCT03837808	Nasopharyngeal ... Nasopharyngeal ... Nasopharyngeal ... Head and Neck N...	Nimotuzumab Cisplatin	18 Years - 70 Years	Sun Yat-sen University
Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)	NCT03769467	Nasopharyngeal ... Nasopharyngeal ... Epstein-Barr Vi... Epstein-Barr Vi... Epstein-Barr Vi...	tabelecleucel pembrolizumab	12 Years -	Atara Biotherapeutics
Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma	NCT03837808	Nasopharyngeal ... Nasopharyngeal ... Nasopharyngeal ... Head and Neck N...	Nimotuzumab Cisplatin	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for nasopharyngeal diseases