Clincosm LogoSign in Get a demo

Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04401800
Collaborator
(none)
66
Enrollment
10
Locations
2
Arms
26.9
Anticipated Duration (Months)
6.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma
Actual Study Start Date :
Sep 4, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Safety Run-in

Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle

Drug: Lenvatinib
Capsules administered orally once daily

Drug: Tislelizumab
200 mg intravenous (IV) infusion administered on Day 1 of each cycle
Experimental: Part 2: Lenvatinib

Lenvatinib at the recommended phase 2 dose (RP2D) determined from Part 1 + tislelizumab in 21-day cycles for up to 12 months

Drug: Lenvatinib
Capsules administered orally once daily

Drug: Tislelizumab
200 mg intravenous (IV) infusion administered on Day 1 of each cycle

Outcome Measures

Primary Outcome Measures

  1. Overall Response Rate (ORR) as assessed by Central Imaging Facility based on RECIST v1.1 [Up to 12 months]

Secondary Outcome Measures

  1. Number of participants experiencing Adverse Events (AEs) [Up to 12 months]

  2. Number of participants experiencing Severe Adverse Events (SAEs) [Up to 12 months]

  3. Overall Response Rate (ORR) [Up to 12 months]

  4. Duration Of Response (DOR) [Up to 12 months]

  5. Disease Control Rate (DCR) [Up to 12 months]

  6. Progression-Free Survival (PFS) [Up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:

  1. Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.

  2. Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy and is not amenable to a curative treatment approach

  3. Did not receive any systemic treatment before and is unwilling to accept standard of care treatment or not suitable for standard of care treatment as judged by investigators

  4. European Cancer Oncology Group (ECOG) Performance Status ≤ 1

  5. Child-Pugh A classification for liver function assessed within 7 days of first dose of study drugs

Key Exclusion Criteria:

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

  2. Any active malignancy ≤ 2 years before the first dose of study drugs except for 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)

  3. Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drugs

  4. Any known brain or leptomeningeal metastases

  5. Concurrent participation in another therapeutic clinical study

NOT: Other protocol defined Inclusion/Exclusion criteria may apply NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Hospital Hefei Anhui China 230001
2 Peking Union Medical College Hospital Beijing Beijing China 100032
3 Nanfang Hospital Guangzhou Guangdong China 510515
4 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150000
5 Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200092
6 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200120
7 The First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shanxi China 710061
8 West China Hospital ,Sichuan University Chengdu Sichuan China 610041
9 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
10 Sun Yat-sen University - Cancer Center (SYSUCC) Guangzhou China 510060

Sponsors and Collaborators

  • BeiGene

Investigators

  • Study Director: Song Yujiao, BeiGene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT04401800
Other Study ID Numbers:
  • BGB-A317-211
  • CTR20200972
First Posted:
May 26, 2020
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib

Study Results

No Results Posted as of Oct 25, 2021