Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer

NCT06455072 | Recruiting Phase 2 DMC

• 1 other identifier: K2022173
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

In recurrent advanced cervical cancer, patients were prone to drug resistance who have relapsed within prior platinum-based chemotherapy. However, immune checkpoint inhibitor's combination therapy has become a promising strategy for advanced cervical cancer. Epidermal Growth Factor Receptor (EGFR) is overexpressed in cervical cancer cells. Stereotactic radiotherapy (SBRT) can enhance the efficacy of immunotherapy.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  2years

Secondary Outcomes (1)

• PFS

  2years

Study Arms (1)

Nituzumab Plus Serplulimab Combined With SBRT

EXPERIMENTAL

Nituzumab was given intravenously (400mg qw, 21 days per cycle), and Serplulimab was administered intravenously (200mg once every 3 weeks).The dose was 30-50 Gy in three to five fractions and the number of lesions was no more than four by SBRT. The treatment was continued until disease progression, death or intolerant toxicity.

Drug: Nituzumab; Drug: Serplulimab

Interventions

Nituzumab DRUG

EGFR monoclonal antibody

Also known as: monoclonal antibody

Nituzumab Plus Serplulimab Combined With SBRT

Serplulimab DRUG

PD-1 (programmed death receptor 1) monoclonal antibody

Also known as: Immune checkpoint inhibitors

Nituzumab Plus Serplulimab Combined With SBRT

Eligibility Criteria

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

You may qualify if:

• \) Prospective participants will be voluntarily enrolled in this research study and will provide written informed consent, demonstrating the ability to adhere to scheduled visits and associated procedures.
• \) Ineligibility due to failure of standard systemic treatment for persistent, recurrent, or metastatic cervical cancer (defined as progression or recurrence within six months after at least one cycle of standard systemic treatment; patients who have previously received anti-PD-1/PD-L1 antibody treatment and achieved CR, PR, or SD≥6 months may still be considered).
• \) Not suitable for local treatments such as curative surgery or radiotherapy. 6) A minimum interval of four weeks must occur between the completion of prior systemic therapy and administration of the investigational drug. Additionally, any treatment-related adverse events must have resolved to CTCAE V5.0 grade ≤1 (excluding hair loss and fatigue).
• \) At least one measurable lesion must serve as a target lesion according to RECIST V1.1 criteria.
• \) Presence of at least one non-target lesion amenable to SBRT is also necessary.
• \) Eastern Cooperative Oncology Group Performance Status (ECOG PS) score should be either 0 or 1.
• ）Expected survival time should exceed 12 weeks 11）Female subjects capable of reproduction need to utilize effective contraception throughout the study period and for at least five months following their final dose of the investigational drug 12）Subjects are required to consent providing sufficient tumor tissue samples for EGFR expression detection including archived tumor samples (paraffin blocks or an adequate number of unstained slides meeting study requirements); if no archived tumor tissue samples are available, subjects must agree on biopsy from the tumor site 13）Good organ function and bone marrow hematopoietic function.

You may not qualify if:

• Diagnosed with malignancies other than basal cell carcinoma, squamous cell carcinoma of the skin, in situ carcinoma cured by surgical resection, and/or papillary thyroid carcinoma cured by surgery within 5 years prior to the initial dose. Participants must have pathological types other than cervical squamous cell carcinoma.
• Participants who are scheduled for or have previously undergone organ or bone marrow transplantation.
• Individuals with acute or chronic active hepatitis B or C infection, who have HBV DNA levels greater than 200IU/ml or 103 copies/ml, or are positive for anti-HCV antibodies with HCV-RNA levels above the detection limit may be eligible. Additionally, individuals with acute or chronic active hepatitis B or C infection who have been treated with nucleoside analog antiviral agents and have HBV DNA or HCV-RNA levels below the specified criteria or below the detection limit may also be eligible.
• Individuals with meningeal metastasis or symptomatic central nervous system (CNS) metastasis may be considered for this study. Furthermore, individuals with asymptomatic brain metastasis that has been treated and symptoms stabilized for at least 2 weeks may also qualify if they meet specific criteria: presence of measurable lesions outside of the CNS; absence of metastasis to certain areas within the brain; no history of intracranial hemorrhage; discontinuation of hormone therapy at least 14 days prior to receiving the first dose of study drug.
• Any life-threatening bleeding event within the past 3 months, including the requirement for blood transfusion, surgical intervention or local treatment, or ongoing pharmacological therapy.
• Any arterial thrombosis, embolism, or ischemia within the past 6 months, such as myocardial infarction, unstable angina, or cerebrovascular accident. A history of any significant thromboembolic event within the past 3 months, such as deep vein thrombosis or any other thromboembolic event (thrombosis related to a portacatheter or central venous catheter insertion site, superficial vein thrombosis, or a stable post-treatment thrombosis is not considered "significant" thromboembolic event).
• Hepatic vein thrombus involving both the hepatic trunk and the left and right branches, or involving both the trunk and the superior mesenteric vein, inferior vena cava; superior vena cava thrombus, superior vena cava syndrome.
• Tumor invasion of surrounding important organs or blood vessels (such as the great vessels of the mediastinum, the superior vena cava, the inferior vena cava, the abdominal aorta, the iliac vessels, the trachea, the esophagus, etc.), or the risk of developing a tracheo-esophageal fistula or an esophago-pleural fistula.
• Uncontrollable hypertension, with a systolic blood pressure of ≥150mmHg or a diastolic blood pressure of ≥100mmHg, history of hypertension crisis or hypertension cerebral infarction.
• Symptomatic congestive heart failure (New York Heart Association classification II-IV). Symptomatic or uncontrolled arrhythmia. QT interval prolongation, QTcF\>470ms.
• Severe bleeding tendency or coagulation disorder, or currently receiving thrombolytic therapy.
• History of gastrointestinal perforation and/or fistula within the past 6 months, history of bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colon resection or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
• History of interstitial pneumonitis, drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, or active pneumonitis. 15) Active tuberculosis (TB), who are currently receiving anti-TB treatment or have received anti-TB treatment within 1 year prior to the start of the study.
• \) Individuals with Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibody positive), known active syphilis infection.
• \) Severe infections that are active or not well controlled. A severe infection within 4 weeks prior to the first dose, including but not limited to hospitalization due to infection, sepsis, or severe pneumonia complications.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Zhangzhou Municipal Hospital of Fujian Province: collaborator

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350011, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Antibodies, Monoclonal; Immune Checkpoint Inhibitors

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; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Qin Xu

  Fujian Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Qin Xu

CONTACT

+8613950419396; 1379423879@qq.com

Li Li

CONTACT

+8615259835038; 15259835038@163.com

Study Design

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

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: February 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CN (1)