A Phase Ⅱ/Ⅲ Study of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

NCT06755515 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: NTP-F520-502
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (3)

• Objective tumor response rate (ORR) assessed by RECIST1.1

  Defined as the proportion of subjects who achieves a best overall response of CR or PR based on RECIST1.1

  up to 2 years

• Progression Free Survival (PFS) assessed by RECIST1.1

  Defined as the time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.

  up to 2 years

• Overall Survival (OS)

  Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason

  up to 2 years

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Time to Response (TTR)

  up to 2 years

Other Outcomes (2)

• The Incidence and Severity of adverse events (AEs) and serious adverse events (SAEs)

  up to 2 years

• Healthy related quality of life (HRQoL)

  up to 2 years

Study Arms (2)

Rulonilimab plus cisplatin/carboplatin + paclitaxel ± bevacizumab

EXPERIMENTAL

Drug: Rulonilimab; Drug: cisplatin/carboplatin + paclitaxel ± bevacizumab

Placebo plus cisplatin/carboplatin + paclitaxel ± bevacizumab

PLACEBO COMPARATOR

Drug: Placebo; Drug: cisplatin/carboplatin + paclitaxel ± bevacizumab

Interventions

Rulonilimab DRUG

Drug: Rulonilimab Description: iv, 200mg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Bevacizumab Description: iv, 15mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Cisplatin Description: iv, 50mg/m\^2 every 3 weeks, for up to 6 cycles. Drug: Carboplatin Description: iv, AUC 4\~6 every 3 weeks, for up to 6 cycles. Drug: Paclitaxel Description: iv, 175mg/m\^2 every 3 weeks, for up to 6 cycles.

Rulonilimab plus cisplatin/carboplatin + paclitaxel ± bevacizumab

Placebo DRUG

Drug: placebo Description: iv, every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Bevacizumab Description: iv, 15mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Cisplatin Description: iv, 50mg/m\^2 every 3 weeks, for up to 6 cycles. Drug: Carboplatin Description: iv, AUC 4\~6 every 3 weeks, for up to 6 cycles. Drug: Paclitaxel Description: iv, 175mg/m\^2 every 3 weeks, for up to 6 cycles.

Placebo plus cisplatin/carboplatin + paclitaxel ± bevacizumab

cisplatin/carboplatin + paclitaxel ± bevacizumab DRUG

cisplatin/carboplatin + paclitaxel ± bevacizumab

Placebo plus cisplatin/carboplatin + paclitaxel ± bevacizumab; Rulonilimab plus cisplatin/carboplatin + paclitaxel ± bevacizumab

Eligibility Criteria

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

You may qualify if:

• Women aged 18 years and above;
• Patients with advanced (\[FIGO\] stage IVB) cervical cancer, patients with persistent, recurrent or metastatic cervical cancer that progresses confirmed by histopathology or cytology, and the following conditions must be met:
• According to RECIST1.1 criteria, subjects must have at least one measurable target lesion examined by Imaging tests (including Not to receive radiation therapy or other locoregional therapy unless the lesion PD or has tumor activity by biopsy-confirmed);
• Those with 0-1 scores on the American Eastern Oncology Collaboration Group (ECOG) scale
• Expected survival ≥3 months;
• Those who agree to provide archived tumor tissue samples or before randomized within 3 years or fresh tissue samples;
• The function of vital organs meets the following requirements (drugs with blood components and cell growth factors are not allowed to be used within 2 weeks before the first administration) :
• Blood routine: Absolute neutrophil count ≥1.5×109/L; Platelet ≥75×109/L; Hemoglobin ≥90g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; If liver metastasis was present, TBIL≤3×ULN, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN a creatinine clearance (CrCl) ≥ 50 mL/min if Cr\>1.5×ULN; Coagulation function: International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN.
• Thyroid function: Thyroid stimulating hormone (TSH) in the normal range; If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) must be normal or abnormal without clinical significance.
• Willingness to participate in the clinical trial; completely understanding and knowing about the study and signing the ICF; willingness and capability to comply with the requirements of the study.

You may not qualify if:

• Patients with pathological tissue types of mucinous adenocarcinoma, gastric adenocarcinoma, clear cell adenocarcinoma, mesonephric tubular adenocarcinoma and other special types of adenocarcinoma；
• Those who previously treated with T-cell co-stimulation, Antiangiogenic drugs (bevacizumab), immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), Targeting immune co-stimulatory factors drug (ICOS, CD40, CD137, GITR, OX40 antibodies);
• Those who have received anti-tumor treatment within 4 weeks before the first dose or within 5 half-lives of the drug (whichever is shorter);
• Immunosuppressive, systemic hormone therapy within 2 weeks prior to initial administration for immunosuppressive purposes (daily dose equivalent to prednisone\>10mg of systemic corticosteroid);
• The toxicity of previous anti-tumor therapy did not return to CTCAE V5.0 ≤ grade 1 (except hair loss);
• A history of other malignancies within the last 5 years, except locally curable cancers (limited to Radical melanoma, basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast);
• Patients with primary central nervous system (CNS) malignancies, CNS metastases that have failed local treatment, and carcinomatous meningitis; the following conditions can be included (regular imaging examinations of the disease site): a. No progressive CNS symptoms caused by brain metastases, no need for steroid hormone treatment, and the lesion is less than 1.5 cm; b. Stable for ≥4 weeks after adequate treatment and neurological symptoms (excluding residual signs or symptoms) have returned to baseline levels for \>2 weeks before the first dose;
• Patients with uncontrollable pleural effusion, pericardial effusion or peritoneal effusion that requires repeated drainage (more than once a month) (can be enrolled after stable treatment for more than 1 month);
• Patients with a history of organ transplantation or allogeneic bone marrow transplantation; or autologous stem cell transplantation within 3 months before the first dose;
• Patients who have undergone major surgery or have not yet recovered from surgery within 4 weeks before the first dose (except for diagnostic surgery);
• Physical examination or laboratory test findings:
• Hepatitis B: HBsAg positive and/or HBcAb positive, and HBV-DNA\>500IU/mL or 2500 copies/mL; Hepatitis C: HCV antibody positive, and HCV-RNA positive or above the upper limit of normal value; Human immunodeficiency virus antibody (Anti-HIV) positive; Active Treponema pallidum infection;
• Patients with thrombosis who need treatment in the acute stage;
• Those who have uncontrolled or severe cardiovascular disease, such as New York Heart Association (NYHA) Class II or above congestive heart failure or LVEF\<50%, unstable angina, myocardial infarction and other cardiovascular disease within 6 months before the first dose; Poorly controlled arrhythmias; Difficult to control hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg after drug therapy);
• Patients with the following medical histories, including but not limited to active autoimmune diseases, active infections (such as active tuberculosis), severe mental illness, severe endocrine diseases (such as type 1 diabetes, type 2 diabetes that cannot be controlled by drugs), etc.;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Shandong New Time Pharmaceutical Co., LTD

Linyi, Shandong, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Carboplatin

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; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: September 26, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

CN (1)