To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors

• ClinicalTrials.gov Identifier: NCT05014828
• Recruitment Status: Recruiting
• First Posted: August 20, 2021
• Last Update Posted: May 23, 2023
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: July 28, 2021
• First Posted Date: August 20, 2021
• Last Update Posted Date: May 23, 2023
• Actual Study Start Date: September 18, 2021
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 16, 2021)

• Part 1: Percentage of Participants Reporting One or More Dose-Limiting Toxicities (DLTs) Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 28 days in Part 1 ]
• Part 1: Number of Participants with Clinically Significant physical examinations, electrocardiograms (ECGs), and laboratory assessments [ Time Frame: Up to 28 days in Part 1 ]
• Part 2: Overall response rate (ORR) [ Time Frame: up to approximately 3.5 years ]
  Defined as the proportion of participants who achieved complete response (CR), or partial response (PR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 16, 2021)

• Progression-Free Survival (PFS) [ Time Frame: up to approximately 3.5 years ]
  PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first
• Duration Of Response (DOR) [ Time Frame: up to approximately 3.5 years ]
  DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death
• Disease Control Rate (DCR) [ Time Frame: up to approximately 3.5 years ]
  DCR is defined as the percentage of participants who have shown Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as the best overall response in accordance with the RECIST version 1.1 criteria.
• Overall Survival (OS) [ Time Frame: up to approximately 3.5 years ]
  OS defined as the time from start of treatment to the date of death due to any cause
• Part 2: Proportion of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: up to approximately 3.5 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors
• Official Title: A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors
• Brief Summary: This study includes 2 parts. Part 1 is a safety run-in stage and part 2 is to assess the efficacy and safety of tislelizumab in combination with lenvatinib
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumor

Intervention

• Drug: lenvatinib
  Capsules administered orally
• Drug: Tislelizumab
  intravenous (iv) infusion
  Other Name: BGB-A317

Study Arms

Experimental: Safety Run in Stage and Combination Assessment

lenvatinib + tislelizumab

Interventions:

• Drug: lenvatinib
• Drug: Tislelizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 16, 2021): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key inclusion criteria:

1. Signed informed consent form (ICF) and able to comply with study requirements
2. Histologically and/or cytologically confirmed advanced solid tumor types such as one of following: Non-small cell lung cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Colorectal Cancer (UC), or Renal Cell Carcinoma (RCC).
3. At least 1 measurable lesion per RECIST version 1.1
4. Tumor tissue (approximately 10 unstained slides) for central laboratory assessment of pd-l1 status for the NSCLC cohort during the screening period, and for retrospective analysis of other exploratory biomarkers related to response and resistance for NSCLC, SCCHN, UC, or GC cohorts in a BeiGene designated central or test laboratory.
5. ECOG performance status ≤ 1

Key exclusion criteria:

1. For the NSCLC cohort, active leptomeningeal disease or uncontrolled, untreated brain metastasis will be excluded. For other cohorts than NSCLC, patients with known leptomeningeal disease or brain metastasis will be excluded.
2. Prior therapy with lenvatinib or an anti-pd-1, anti-pd-l1, anti-pd-l2 or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways
3. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
4. Inability to swallow capsules or disease/procedure significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
5. Have clinically significant bleeding (such as ctcae ≥ grade 2) within 21 days before first dose

NOTE: OTHER PROTOCOL DEFINED INCLUSION/EXCLUSION CRITERIA MAY APPLY

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BeiGene; +1-877-828-5568; clinicaltrials@beigene.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05014828
• Other Study ID Numbers: BGB-A317-212
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: BeiGene
• Original Responsible Party: Same as current
• Current Study Sponsor: BeiGene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: BeiGene
• Verification Date: October 2022