Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer

NCT05799469 | Not Yet Recruiting Phase 2

• 1 other identifier: SMA-CC-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.

Conditions

Locally Advanced Cervical Cancer

Keywords

Cervical Cancer; Local advanced; Concurrent chemoradiotherapy; Immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date.

  The cut-off date is event-driven and estimated to be approximately 48 months.

Secondary Outcomes (7)

• Objective Response Rate(ORR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Progression-Free Survival (PFS) at Month 12/36

  The cut-off date is event-driven and estimated to be approximately 48 months.

• Overall Survival (OS) at Month 12/24/36

  The cut-off date is event-driven and estimated to be approximately 48 months.

• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score and Physical Function Score.

  Baseline and up to approximately 48 months

Study Arms (1)

treatment arm

EXPERIMENTAL

Participants receive envafolimab 150 mg subcutaneously (SC) on Day 1 of each week cycle (QW) for 8 cycles followed by envafolimab 300 mg SC on Day 1 of each 3-week cycle (Q3W) until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraws informed consent, or envafolimab treatment over 2 years. During the QW dosing period of envafolimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 45 Gray Units (Gy)with the total duration of radiation treatment not to exceed 56 days.

Drug: Envafolimab; Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Radiation: Brachytherapy (BT)

Interventions

Envafolimab DRUG

SC

Also known as: KN035

treatment arm

Cisplatin DRUG

IV infusion

treatment arm

External Beam Radiotherapy (EBRT) RADIATION

45-50.4Gy

treatment arm

Brachytherapy (BT) RADIATION

Performed according to clinically required dose

treatment arm

Eligibility Criteria

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

You may qualify if:

• The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;
• Female aged 18-75 years (at the time of signing the informed consent);
• ECOG score of 0-1 within 7 days prior to first study intervention dose;
• Expectation of life ≥ 12 weeks;
• Locally advanced squamous cell carcinoma , adenocarcinoma or adenosquamous -carcinoma of the cervix confirmed by pathological histological or clinical diagnosis according to cervical cancer F IGO stage (2018 version) as I B3 , IIA2 , IIB , I II-IVA stage ;
• Pathological specimens (≥ 18 eligible tissue sections) may be provided for biomarker testing;
• No prior surgery for cervical cancer (excluding staging surgery), radiotherapy, chemotherapy, systemic therapy (including investigational agents), or immunotherapy ;
• At least 1 measurable cervical lesion or metastatic lymph node meeting RECIST1.1 target lesion criteria by CT scan or MRI within 28 days prior to treatment;
• Adequate major organ function meeting the following criteria:
• Hematology (need not be transfused within 14 days and hematopoietic stimulating factor drugs within 7 days without correction testing): hemoglobin (Hb) ≥ 90 g/L; absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelets (PLT) ≥ 80 × 109/L;
• Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum total bilirubin (TBIL) ≤ 1.5 × ULN (in subjects with Gilbert 's syndrome, ≤ 3 × ULN); serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min;
• Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;
• Thyroid function is normal，defined as thyroid stimulating hormone (TSH) within normal limits. If baseline TSH is out of normal range, subjects with total T3 (or FT3) and FT4 within normal range can also be enrolled;
• Adequate organ function as judged clinically appropriate for the study by the physician.

You may not qualify if:

• Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;
• Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;
• Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events Version 5.0 \[CTCAE 5.0\]);
• Subjects with any severe and/or uncontrolled disease. Including:
• Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
• Patients with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms) and ≥ Grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification);
• Active or uncontrolled serious infection (≥ CTCAE Grade 2 infection);
• Previous (non infectious) pneumonia/interstitial lung disease still requires steroid treatment or currently has (non infectious) lung disease;
• Active syphilis;
• Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• Patients with a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10 mmol/L);
• Urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein \> 1.0g;
• Patients who received major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment; or had wounds or fractures that were not healed for a long time;
• Severe arterial/venous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism within 6 months before the start of study treatment;

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing university Cancer Hospital

Chongqing, CHN, 400000, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

envafolimab; Cisplatin; Brachytherapy

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Therapeutics

Study Officials

• Qi Zhou, PhD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingtao Long, MD

CONTACT

+8602365075619; longxingtao2009@163.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: Professor

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 5, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)