AdvanTIG-202: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Previously Treated Recurrent or Metastatic Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693234
• Other study ID #: BGB-A317-A1217-202
• Secondary ID: 2020-004657-77Ad
• Status: Completed
• Phase: Phase 2
• Start date: February 15, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, 2-cohort, multicenter, Phase 2 study to evaluate the efficacy and safety of tislelizumab combined with or without ociperlimab (BGB-A1217) in participants with previously treated recurrent or metastatic cervical cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: August 31, 2023
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.

2. Progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and is not amenable to curative treatment (eg, systemic chemotherapy, surgery, or radiotherapy).

3. Measurable disease as assessed by RECIST v1.1. Note: A lesion in an area subjected to prior loco-regional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression in the lesion since the therapy as defined by RECIST v1.1.

4. Participants must submit qualified archival tumor tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or approximately 15 [at least 6] unstained slides) with an associated pathology report, or agree to a tumor biopsy for determination of Programmed death-ligand 1 (PD-L1) expression and other biomarker analyses (fresh tumor biopsies are strongly recommended at baseline in participants with readily accessible tumor lesions and who consent to the biopsies).

5. Participant must have adequate organ function as indicated by the screening laboratory values obtained within 7 days before the first study treatment.

Exclusion Criteria:

1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

2. Any active malignancy = 2 years before first dose of study drug 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 breast).

3. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention).

4. Any major surgical procedure = 28 days before first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drug.

5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc.) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Tislelizumab
Administered as specified in the treatment arm
• Ociperlimab
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Bulgaria	"Mhat uni hospital" ood	Panagyurishte
Bulgaria	Acibadem city clinic tokuda umhat ead, department of medical oncology	Sofia
Bulgaria	Medical center nadezhda clinical eood	Sofia
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Sun yat-sen memorial hospital, sun yat-sen university (south)	Guanzhou	Guangdong
Korea, Republic of	Kyemyung University Dongsan Hospital	Daegu
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea Institute of Radiological & Medical Sciences	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Poland	Przychodnia lekarska komed	Konin
Russian Federation	Arkhangelsk regional clinical oncological dispensary	Arkhangel'sk
Russian Federation	State budgetary healthcare institution-chelyabinsk regional clinical center of oncology and nuclear	Chelyabinsk
Russian Federation	State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region	Krasnodar	Krasnodar Krai
Russian Federation	Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary"	Pyatigorsk	Stavropol Region
Russian Federation	Fsbi of higher education"ogarev mordovia state university"	Saransk	Mordovia Republic
Taiwan	Chi Mei Hospital, Liouying	Tainan
Taiwan	Linkou Chang Gung Memorial Hospital	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok
Ukraine	Medical and diagnostic center of private enterprise private production company "acinus"	Kirovograd	Kirovohradska Oblast
Ukraine	Medical center of llc oncolife	Kropyvnytskyi

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

Bulgaria,  China,  Korea, Republic of,  Poland,  Russian Federation,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohort 1		approximately 3 years
Secondary	Objective Response Rate (ORR) assessed by investigator's review per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 for Cohort 1		approximately 3 years
Secondary	Objective Response Rate (ORR) assessed by both IRC and investigator's review per RECIST v1.1 for Cohort 2		approximately 3 years
Secondary	Duration of Response (DOR) assessed by both IRC and investigator's review		approximately 3 years
Secondary	Progression Free Survival (PFS) assessed by both IRC and investigator's review		Date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years
Secondary	Time to Response (TTR) assessed by both IRC and investigator's review		date of first dose of study drug to first documentation of response, approximately 3 years
Secondary	Disease Control Rate (DCR) assessed by both IRC and investigator's review		the proportion of patients who achieve CR, PR, or stable disease (SD) approximately 3 years
Secondary	Clinical Benefit Rate (CBR) assessed by both IRC and investigator's review		the proportion of patients who achieve CR, PR, or durable SD (SD = 24 weeks), approximately 3 years
Secondary	Overall Survival (OS) assessed by both IRC and investigator's review		Date of first dose of study drug until the date of death from any cause for Cohorts 1 and 2, approximately 3 years
Secondary	Health-related quality of life (HRQoL)	Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	approximately 3 years
Secondary	Adverse events (AEs) and serious adverse events (SAEs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 for Cohorts 1 and 2		approximately 3 years
Secondary	Serum BGB-A1217 and tislelizumab concentrations at specified timepoints		specified timepoints up to 30 (±7) days after last dose, approximately 3 years
Secondary	Immunogenic responses to BGB-A1217 and tislelizumab, evaluated through the detection of antidrug antibodies (ADAs)		date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years
Secondary	Health-related quality of life (HRQoL)	Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24)	approximately 3 years