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

NCT ID: NCT05014828

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-18
• Study Completion Date: 2024-07-10

Brief Summary

This clinical trial evaluated the safety and potential benefits of combining two cancer treatments, tislelizumab and lenvatinib, in Chinese participants with advanced or metastatic cancers, including lung, head and neck, bladder, kidney, and stomach cancer. The study included two parts: the first part assessed how safe the drug combination was, and the second part examined how well it worked.

A small group of participants initially received the drugs to determine the appropriate dose, and if the treatment was well tolerated, additional participants were treated at that dose. Participants remained on the treatment unless their cancer progressed, they experienced serious side effects, or they chose to stop.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety Run In

Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).

Group Type: EXPERIMENTAL

lenvatinib

Intervention Type: DRUG

Administered at the dose of 20 mg orally, once daily.

Tislelizumab

Intervention Type: DRUG

400 mg administered intravenously on Day 1 of each 42-day cycle

Part 2: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Cohort

Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.

Group Type: EXPERIMENTAL

lenvatinib

Intervention Type: DRUG

Administered at the dose of 20 mg orally, once daily.

Tislelizumab

Intervention Type: DRUG

400 mg administered intravenously on Day 1 of each 42-day cycle

Part 2: Renal Cell Carcinoma (RCC) Cohort

Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.

Group Type: EXPERIMENTAL

lenvatinib

Intervention Type: DRUG

Administered at the dose of 20 mg orally, once daily.

Tislelizumab

Intervention Type: DRUG

400 mg administered intravenously on Day 1 of each 42-day cycle

Part 2: Non-Small Cell Lung Cancer (NSCLC) Cohort

Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.

Group Type: EXPERIMENTAL

lenvatinib

Intervention Type: DRUG

Administered at the dose of 20 mg orally, once daily.

Tislelizumab

Intervention Type: DRUG

400 mg administered intravenously on Day 1 of each 42-day cycle

Part 2: Gastric Cancer (GC) Cohort

Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.

Group Type: EXPERIMENTAL

lenvatinib

Intervention Type: DRUG

Administered at the dose of 20 mg orally, once daily.

Tislelizumab

Intervention Type: DRUG

400 mg administered intravenously on Day 1 of each 42-day cycle

Part 2: Urothelial Cancer (UC) Cohort

Participants with cisplatin ineligible, systemic therapy naive advanced UC, were to be treated with tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD). This cohort was closed prior to any participant enrollment based on emerging external data.

Group Type: EXPERIMENTAL

lenvatinib

Intervention Type: DRUG

Administered at the dose of 20 mg orally, once daily.

Tislelizumab

Intervention Type: DRUG

400 mg administered intravenously on Day 1 of each 42-day cycle

Interventions

lenvatinib

Administered at the dose of 20 mg orally, once daily.

Intervention Type: DRUG

Tislelizumab

400 mg administered intravenously on Day 1 of each 42-day cycle

Intervention Type: DRUG

Other Intervention Names

BGB-A317

Eligibility Criteria

Inclusion Criteria

1. Participants had signed an informed consent form and were able to comply with all study requirements.

2. Participants had a histologically and/or cytologically confirmed diagnosis of advanced solid tumors, which included one of the following types:

• Non-Small Cell Lung Cancer (NSCLC)
• Squamous Cell Carcinoma of the Head and Neck (SCCHN)
• Gastric Cancer (GC)
• Urothelial Carcinoma (UC)
• Renal Cell Carcinoma (RCC)

3. Participants had at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

4. Tumor tissue samples (approximately 10 unstained slides) were provided for central laboratory assessment of programmed death-ligand 1 (PD-L1) expression in the NSCLC cohort during the screening period. These samples were also used for retrospective exploratory biomarker analyses related to treatment response and resistance across the NSCLC, SCCHN, UC, or Gastric Cancer (GC) cohorts, in a central or designated test laboratory approved by BeiGene.

5. Participants had an Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1

Exclusion Criteria

1. For participants in the NSCLC cohort, those with active leptomeningeal disease or uncontrolled, untreated brain metastases were excluded. In cohorts other than NSCLC, any participant with known leptomeningeal disease or brain metastases was excluded.

2. Participants who had received prior therapy with lenvatinib, or with antibodies targeting programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), or any other agents specifically targeting T-cell costimulatory or immune checkpoint pathways, were excluded.

3. Participants with a history of interstitial lung disease, non-infectious pneumonitis, or any uncontrolled pulmonary conditions (including but not limited to pulmonary fibrosis or acute lung diseases) were excluded.

4. Participants who were unable to swallow capsules, or who had diseases or previous procedures that significantly affected gastrointestinal function such as malabsorption syndrome, surgical resection of the stomach or small bowel, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete bowel obstruction were excluded.

5. Participants who had experienced clinically significant bleeding (classified as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events [CTCAE]) within 21 days prior to the first dose were excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

The Peoples Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Cancer Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

References

BGB-A317-212: A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors. Poster No: 2610 presented at ASCO, Chicago, IL, May 31-June 4, 2024

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTR20211874

Identifier Type: OTHER

Identifier Source: secondary_id

BGB-A317-212

Identifier Type: -

Identifier Source: org_study_id