A Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical Cancer

Recurrent or Metastatic Cervical Cancer Clinical Trial

Official title:

A Single-arm, Open-label, Multicenter, Phase II Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04623333
• Other study ID #: TQB2450-II-09
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 30, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Beihua Kong, Doctor
• Phone: 0531-82166671
• Email: kongbeihua[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the efficacy and safety of TQB2450 injection in the treatment of PD-L1 positive recurrent or metastatic cervical cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Understood and signed an informed consent form; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy = 3 months; 3. Diagnosed as recurrent or metastatic cervical cancer; 4. Has received =first-line platinum-containing chemotherapy, and disease progress or recur during or after treatment; 5. PD-L1 positive, and the combined positive score (CPS) =1; 6. Has at least one measurable lesion; 7. Adequate laboratory indicators; 8. Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months.

Exclusion Criteria:

• 1. Combined diseases and medical history: a) Has diagnosed and/or treated additional malignancy within 3 years prior to first dose;b) Diagnosed as other special pathological types, such as mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumor and so on;c) Unalleviated toxicity = grade 1 due to any previous anticancer therapy;d) Has received major surgical treatment, open biopsy and so on within 28 days before the start of the study;e) Has a unhealed wound or fracture for a long time; f) Has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study; g) Has a history of psychotropic substance abuse and unable to quit or mental disorders; h)Has any serious and / or uncontrolled disease; 2.Tumor-related symptoms and treatment: a) Has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study; b) Has received proprietary Chinese medicine with anti-tumor indications in the NMPA approved drug instructions within 2 weeks before the start of the study; c) Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and other related drugs; d) Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; e) Has symptomatic central nervous system (CNS) disease and/or cancerous meningitis, pia mater disease; 3. Related to treatment of research: a) Has received attenuated live vaccine within 28 days before first dose or planned to received attenuated live vaccine during the study period; b) Has severe hypersensitivity reactions after using monoclonal antibodies; c) Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study; d) Has a history of active tuberculosis; 4.Has Participated in other clinical trials within 4 weeks before first dose. 5.According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Related Conditions & MeSH terms

• Recurrent or Metastatic Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• TQB2450
TQB2450 1200mg administered intravenously (IV) on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR) evaluated by Independent Review Committee (IRC)	ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.	up to 12 months
Secondary	Overall response rate (ORR) evaluated by investigator	ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.	up to 12 months
Secondary	Disease Control Rate (DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 12 months
Secondary	Duration of response (DOR)	The time when the participants first achieved complete or partial remission to disease progression.	up to 12 months
Secondary	Progression free survival (PFS)	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.	up to 12 months
Secondary	Overall survival (OS)	OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.	up to 18 months
Secondary	DOR rate (= 6 months)	The percentage of participants achieved complete or partial remission = 6 months.	up to 12 months