Phase 3, Double-Blind, Randomized Study to Compare the Efficacy and Safety of Tislelizumab Combined With Chemotherapy Versus Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer

Sponsors

Lead sponsor: BeiGene

Source BeiGene
Brief Summary

This is a Phase 3, Multicenter, Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317) Combined With Gemcitabine Plus Cisplatin Versus Placebo Combined With Gemcitabine Plus Cisplatin as First Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer.

Overall Status Recruiting
Start Date April 18, 2019
Completion Date June 2022
Primary Completion Date August 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Progression-free Survival up to 2 years.
Secondary Outcome
Measure Time Frame
Overall Survival up to 2 years.
Duration of response up to 2 years.
Overall response rate up to 2 years.
Progression-free survival as assessed by the investigator up to 2 years.
Progression-free survival after next line of treatment as assessed by the investigator up to 2 years.
Enrollment 256
Condition
Intervention

Intervention type: Drug

Intervention name: Tislelizumab combined with Gemcitabine Plus Cisplatin

Description: Study subjects will receive Tislelizumab, Cisplatin and Gemcitabine on day1 of every 3 weeks, and study subjects will receive Gemcitabine on day8 of every 3 weeks.

Arm group label: Tislelizumab combined with Gemcitabine Plus Cisplatin

Intervention type: Drug

Intervention name: Placebo combined with Gemcitabine Plus Cisplatin

Description: Study subjects will receive Placebo, Cisplatin and Gemcitabine on day1 of every 3 weeks, and study subjects will receive Gemcitabine on day8 of every 3 weeks.

Arm group label: Placebo combined with Gemcitabine Plus Cisplatin

Eligibility

Criteria:

Inclusion Criteria:

1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments

2. Aged between 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)

3. Histologically or cytologically confirmed, recurrent or metastatic NPC

4. Patients must be able to provide fresh or archival tumor tissues (FFPE blocks or approximately 10 [≥ 6] freshly cut unstained FFPE slides) with an associated pathological report. The archival tumor tissues must be collected within 2 years before screening. In the absence of sufficient archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is mandatory

5. ECOG performance status ≤ 1

6. Patients must have ≥ 1 measurable lesions as defined per RECIST v1.1

7. Must be treatment-naive for recurrent or metastatic NPC

Exclusion Criteria:

1. Patients with locally recurrence suitable for curative surgery or radiotherapy

2. Received any approved systemic anticancer therapy, including hormonal therapy, within 28 days prior to initiation of study treatment. The following exception is allowed:

-Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging.

3. Has received any immunotherapy (including but not limited to interferons, interleukin 2, tumor necrosis factor interleukin, and thymoxin) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) of randomization

4. Received prior therapies targeting PD-1 or PD-L1

5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis

6. Active autoimmune diseases or history of autoimmune diseases that may relapse

7. Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Li Zhang, MD Principal Investigator Sun Yat-sen University
Overall Contact

Last name: BeiGene

Phone: +1-877-828-5568

Email: [email protected]

Location
facility status Beijing Cancer Hospital
Location Countries

China

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Tislelizumab combined with Gemcitabine Plus Cisplatin

Arm group type: Experimental

Description: Tislelizumab will be administered at a dose of 200 mg intravenously (IV) once every 3 weeks (Q3W) Gemcitabine 1 g/m2, Day 1, Day 8 of each cycle, administered as an IV infusion within 30 minutes, for 4 to 6 cycles Cisplatin 80 mg/m2, Day 1 of each cycle, administered as an IV infusion over 4 hours for 4 to 6 cycles

Arm group label: Placebo combined with Gemcitabine Plus Cisplatin

Arm group type: Placebo Comparator

Description: Placebo will be administered at a dose of 200 mg intravenously (IV) once every 3 weeks (Q3W) Gemcitabine 1 g/m2, Day 1, Day 8 of each cycle, administered as an IV infusion within 30 minutes, for 4 to 6 cycles Cisplatin 80 mg/m2, Day 1 of each cycle, administered as an IV infusion over 4 hours for 4 to 6 cycles

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov