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

NCT04623333 | Unknown Phase 2

• 1 other identifier: TQB2450-II-09
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent or Metastatic Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall response rate (ORR) evaluated by investigator

  up to 12 months

• Disease Control Rate (DCR)

  up to 12 months

• Duration of response (DOR)

  up to 12 months

• Progression free survival (PFS)

  up to 12 months

• Overall survival (OS)

  up to 18 months

Study Arms (1)

TQB2450 injection

EXPERIMENTAL

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

Drug: TQB2450

Interventions

TQB2450 DRUG

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

TQB2450 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shangdong, 250012, China

Location

MeSH Terms

Conditions

Recurrence; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Central Study Contacts

Beihua Kong, Doctor

CONTACT

0531-82166671; kongbeihua@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 10, 2020
• Study Start: November 30, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: November 10, 2020

Record last verified: 2020-08

Locations

CN (1)