Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma

Sponsor

BeiGene (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05461794

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the efficacy and safety of sitravatinib in combination with tislelizumab for the treatment of participants with esophageal squamous cell carcinoma

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: Sitravatinib Drug: Tislelizumab Drug: Docetaxel Drug: Irinotecan	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Patients With Locally Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma That Progressed on or After Anti-PD-(L)1 Antibody Therapy

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Sitravatinib + Tislelizumab Sitravatinib administered orally and tislelizumab administered intravenously	Drug: Sitravatinib administered orally Drug: Tislelizumab administered intravenously
Experimental: Arm B: Sitravatinib Sitravatinib administered orally	Drug: Sitravatinib administered orally
Experimental: Arm C: Investigator-chosen Chemotherapy Docetaxel or Irinotecan	Drug: Docetaxel administered intravenously Drug: Irinotecan administered intravenously

Arm

Intervention/Treatment

Experimental: Arm A: Sitravatinib + Tislelizumab

Sitravatinib administered orally and tislelizumab administered intravenously

Drug: Sitravatinib

administered orally

Drug: Tislelizumab

administered intravenously

Experimental: Arm B: Sitravatinib

Sitravatinib administered orally

Drug: Sitravatinib

administered orally

Experimental: Arm C: Investigator-chosen Chemotherapy

Docetaxel or Irinotecan

Drug: Docetaxel

administered intravenously

Drug: Irinotecan

administered intravenously

Outcome Measures

Primary Outcome Measures

Arms A and C: Overall Response Rate (ORR) [Up to 2 Years]
ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

Secondary Outcome Measures

Duration of Response (DOR) [Up to 2 Years]
defined as the time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first
Arms A and C: Overall Survival (OS) [Up to 2 Years]
OS is defined as the time from the date of randomization to the date of death due to any cause
Disease Control Rate (DCR) [Up to 2 Years]
DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Clinical Benefit Rate (CBR) [Up to 2 Years]
CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Progression Free Survival (PFS) [Up to 2 Years]
PFS is defined as the time from the date of randomization until first documentation of progression or death, whichever comes first, as assessed by the investigator Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Overall Response Rate (ORR) as assessed by the investigator [Up to 2 Years]
defined as the proportion of patients with a confirmed complete response or partial response per RECIST v1.1
Number of participants with adverse events (AEs) [Up to 2 Years]
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Number of participants with clinically significant changes from baseline in clinical laboratory values [Up to 2 Years]
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Number of participants with clinically significant changes from baseline in vital signs [Up to 2 Years]
Vital signs include blood pressure and pulse rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC, not amenable to treatment with curative intent
At least 1 measurable lesion as defined per RECIST v1.1 as determined by local site investigator/radiology assessment ≤ 28 days before randomization Note: Lesions that had been previously irradiated were considered evaluable provided
ECOG PS score ≤ 1
Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed ≤ 7 days before randomization

Key Exclusion Criteria:

Have any contraindication for receiving treatment with both docetaxel and irinotecan
Patients with tumor located around important vascular structures as shown by imaging or the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding (ie, radiologic evidence of tumors invading or abutting major blood vessels)
Patients with tumor that invades into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) that has an increased risk of fistula during the study treatment period as assessed by the investigator
. History of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization
Have received prior anticancer agents that have same mechanism of action as sitravatinib (eg, RTK inhibitor with a similar target profile or VEGF- or VEGFR-targeted monoclonal antibodies) ther protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Hospital South Brance	Hefei	Anhui	China	230061
2	Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital	Hefei	Anhui	China	230088
3	Beijing Luhe Hospital	Beijing	Beijing	China	101100
4	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China
5	Fujian Cancer Hospital	Fujian	Fujian	China
6	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	35005
7	Sun Yat-Sen University Cancer Center (Huangpu Campus)	Guangzhou	Guangdong	China	510060
8	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong	China	510060
9	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong	China
10	The Tumor Hospital Affiliated to Guangxi Medical University	Nanning	Guangxi	China	530022
11	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150000
12	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan	China	453100
13	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
14	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
15	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
16	Xiangyang Central Hospital	Xiangyang	Hubei	China	441000
17	Hunan Cancer Hospital	Changsha	Hunan	China	410006
18	Northern Jiangsu people's hospital	Yangzhou	Jiangsu	China	225001
19	Ganzhou People'S Hospital / Ganzhou Hospital Affiliated to Nanchang University	Ganzhou	Jiangxi	China	341000
20	The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi	China
21	Jilin Cancer Hospital	Changchun	Jilin	China	130021
22	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning	China
23	Shandong Cancer Hospital	Jinan	Shandong	China	250117
24	Weifang People's Hospital	Weifang	Shandong	China	261000
25	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai	China	200032
26	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China
27	West China Hospital, Sichuan University	Chengdu	Sichuan	China	610041
28	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan	China
29	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
30	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022