A Clinical Study to Explore the Efficacy and Safety of Tislelizumab in Combination With Bevacizumab and Chemotherapy in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer

NCT05247619 | Unknown Phase 2 DMC

• 1 other identifier: BGB-A317-2007
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety of Tislelizumab combined with Bevacizumab and chemotherapy in patients with persistent, recurrent or metastatic cervical cancer.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• mPFS

  mPFS of Tislelizumab in combination with bevacizumab and chemotherapy in patients with persistent, relapsed, or metastatic cervical cancer was assessed by investigators according to RECIST v1.1

  The time from the first dosing of the study drug until the first objective recording of disease progression or death from any cause, whichever occurred first, up to approximately 24 months.

Secondary Outcomes (6)

• ORR

  Up to approximately 24 months

• DCR

  Up to approximately 24 months

• DOR

  DOR: refers to the time from the beginning of the first assessment of a tumor as CR or PR to the first assessment of PD or death from any cause, up to 24 months.

• Adverse Event (AE)

  The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months )

• Serious AE (SAE)

  The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months )

Study Arms (1)

Intervention

EXPERIMENTAL

Tislelizumab + Bevacizumab + Paclitaxel + Cisplatin/Carboplatin

Drug: Tislelizumab / Bevacizumab/Paclitaxel/Cisplatin/Carboplatin

Interventions

Tislelizumab / Bevacizumab/Paclitaxel/Cisplatin/Carboplatin DRUG

Tisleliumab 200mg, Bevacizumab 7.5mg/kg, Paclitaxel 175mg/m2, and Cisplatin 50mg/m2 (or Carboplatin AUC5) IV on day 1 of every 21-day cycle.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and signature of informed consent;
• Age ≥18;
• Eastern United States Cancer Collaboration Group (ECOG) score 0-1;
• Patients with metastatic (IVB), persistent or first recurrent cervical cancer is unsuitable for surgical treatment;
• Histopathology was defined as: cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, patients included in adenocarcinoma histology will be limited to 20% of the entire study population;
• Patients must have lesions that can be measured according to RECIST v1.1 criteria;
• The main organs function well and are defined as:
• Patients received no blood, platelet transfusion or growth factor support treatment within 14 days ≤ the beginning of treatment and was required to:
• x 109/L ANC ≥1.5
• Platelet ≥100 x 109/L
• g/L ≥90
• AST and ALT≤2.5 times ULN (5 times if liver metastasis occurs)
• Serum total bilirubin ≤ ULN 1.5 times
• Serum creatinine \<1.5x upper limit (ULN)
• Urine routine examination, urine protein \<2+

You may not qualify if:

• Patients whose bilateral hydronephrosis can not be alleviated by ureteral stent or percutaneous drainage; non-communicable cystitis CTCAE(5.0 Edition)≥ grade 2;
• hypertension (systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg), hypertension crisis or history of hypertensive encephalopathy, which remains uncontrolled under medication;
• Previous medical history showing newly discovered thrombotic disease within 6 months of screening or during screening; patients with severe wound nonunion, ulcers or fractures;
• Patients with other malignancies and brain metastases;
• Patients with central nervous system diseases, including uncontrolled seizure standard drug therapy, or historical cerebrovascular accidents (CVA, stroke), transient ischemic attacks (TIA) or subarachnoid hemorrhage within six months.
• Previous treatment with antiprogrammed cell death protein-1(anti PD-1), antiprogrammed death ligand-1(anti PD-L1) or anti PD-L2 drugs, or have received another drug treatment (e.g., cytotoxic T lymphocyte-associated antigen-4\[ CTLA-4\]、OX-40,\] antigen patients CD137\[ tumor necrosis factor receptor superfamily member 9(TNFRSF9)\]; A patient who has previously received any VEGF drugs, including bevacizumab.
• Patients who received live vaccinations or had undergone major surgery within 30 days prior to the first administration of the study; patients who were expected to undergo invasive surgery during treatment;
• Active autoimmune diseases requiring systemic treatment in the past two years;
• ≤14 days before the first administration of the study drug, any condition requiring systemic treatment with corticosteroids (prednisone or equivalent \>10 mg/ days) or other immunosuppressive drugs;
• History of known human immunodeficiency virus (HIV) infection;
• Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \>500 IU/mL) or active HCV carriers with detectable levels; Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA \<500 IU/mL) can be enrolled;
• History of interstitial lung disease, non-infectious pneumonia or uncontrolled disease, including pulmonary fibrosis, acute lung disease, etc;
• Severe chronic or active infections (including tuberculosis infections) requiring systemic antimicrobial, antifungal or antiviral therapy within 14 days prior to the first administration of the study drug Note: Patients with viral hepatitis are allowed antiviral therapy;
• with severe cardiovascular diseases such as myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass transplantation in the past 6 months, or new york heart disease association (NYHA) class ii-class IV congestive heart failure (CHF), or history of class NYHA III or IV CHF;
• who are known to be allergic to components of a study drug or its analog;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

tislelizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

jianqing zhu, docter

CONTACT

13605818467; zjq-hz@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 21, 2022
• Study Start: June 30, 2022
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

CN (1)