Cervical CancerPhase 2/3NCT06755515
A Phase Ⅱ/Ⅲ Study of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
A Phase 2/3 study testing Rulonilimab and cisplatin/carboplatin + paclitaxel ± bevacizumab in people with Cervical Cancer, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Rulonilimab and cisplatin/carboplatin + paclitaxel ± bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2024to Sep 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Programmed Cell Death Ligand 1 (PD-L1) positive expression defined by Combined Positive Score (CPS) ≥1; The histopathology types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; Not amenable to curative surgery or concurrent chemoradiotherapy; No prior systemic therapy for advanced, persistent, recurrent or metastatic disease; Patients who had previously received first-line platinum-containing adjuvant or neoadjuvant chemotherapy/radical concurrent chemoradiotherapy and whose time from the last chemotherapy to disease progression was > 6 months were eligible for inclusion.
- 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;
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- 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.
Who cannot join
- 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);
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- 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.;
- have been treated with any other investigational drug/device within 4 weeks prior to initial dosing;
- Those who have a history of drug abuse or alcoholism within 6 months before the first dose;
- Those with a history of severe allergies, known subjects to have been allergic to macromolecular protein preparations/monoclonal antibodies and any components of the experimental drugs;
- Those who have received live or attenuated live vaccines within 4 weeks before the first dose or are scheduled to receive live or attenuated live vaccines during the study;
- Pregnant or lactating women, and female subjects of childbearing age who do not agree to use medically recognized effective contraceptive measures (such as intrauterine devices or condoms) during the study and within 6 months after the last trial drug treatment;
- Those who were judged not suitable for inclusion by the researchers.
- The following conditions are only applicable to those who are excluded from the use of bevacizumab:
- Within 3 months before the first dose, there is clinically significant hematuria, hematemesis or hemoptysis (>2.5mL red blood), or other history of obvious bleeding (such as pulmonary hemorrhage);
- Patients who are receiving thrombolytic/anticoagulant therapy, or need to continue to receive thrombolytic/anticoagulant therapy during the study (prophylactic use of low-dose aspirin is allowed);
- Patients with unhealed, poorly healed wounds or untreated fractures;
- Patients with evidence of gastrointestinal perforation, fistula, intra-abdominal abscess, and free gas in the abdominal cavity within 6 months before the first dose;
- Subjects with urine protein>1+ undergo 24-hour urine protein quantification, and urine protein ≥1g/24 hours;
- Patients with reversible posterior encephalopathy syndrome (PRES) or reversible posterior leukoencephalopathy syndrome (RPLS).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ⅱ/Ⅲ Randomized, Double-Blind, Placebo-Controlled Trial of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.
Read the detailed description
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with Rulonilimab/placebo plus chemotherapy ± bevacizumab, intravenously, at target dose every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
- Conditions
- Cervical Cancer
- Being tested
- Rulonilimab, Placebo, cisplatin/carboplatin + paclitaxel ± bevacizumab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RulonilimabDrug
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.
PlaceboDrug
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.
cisplatin/carboplatin + paclitaxel ± bevacizumabDrug
cisplatin/carboplatin + paclitaxel ± bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Rulonilimab plus cisplatin/carboplatin + paclitaxel ± bevacizumab | Experimental | Not described Receives: Drug: Rulonilimab; Drug: cisplatin/carboplatin + paclitaxel ± bevacizumab |
| Placebo plus cisplatin/carboplatin + paclitaxel ± bevacizumab | Placebo comparator | Not described Receives: Drug: Placebo; Drug: cisplatin/carboplatin + paclitaxel ± bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: up to 2 years
Secondary outcomes (3)
Disease Control Rate (DCR)
Defined as the proportion of subjects' response of CR, PR, or SD based onRECIST1.1
Measured: up to 2 years
Duration of Response (DOR)
Defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first
Measured: up to 2 years
Time to Response (TTR)
Defined as the time from the date of randomization to the date when the response criteria are first met, based on RECIST1.1
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start26 Sep 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755515
- Sponsor's protocol ID
- NTP-F520-502
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ/Ⅲ Randomized, Double-Blind, Placebo-Controlled Trial of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT06755515
- Acronym / sponsor ID
- NTP-F520-502
- Conditions
- Cervical Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.
Detailed description
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with Rulonilimab/placebo plus chemotherapy ± bevacizumab, intravenously, at target dose every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Programmed Cell Death Ligand 1 (PD-L1) positive expression defined by Combined Positive Score (CPS) ≥1; The histopathology types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; Not amenable to curative surgery or concurrent chemoradiotherapy; No prior systemic therapy for advanced, persistent, recurrent or metastatic disease; Patients who had previously received first-line platinum-containing adjuvant or neoadjuvant chemotherapy/radical concurrent chemoradiotherapy and whose time from the last chemotherapy to disease progression was > 6 months were eligible for inclusion.
- 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
Key exclusion criteria (28 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RulonilimabDrug: 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. | Drug | Rulonilimab plus cisplatin/carboplatin + paclitaxel ± bevacizumab |
| PlaceboDrug: 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. | Drug | Placebo plus cisplatin/carboplatin + paclitaxel ± bevacizumab |
| cisplatin/carboplatin + paclitaxel ± bevacizumabcisplatin/carboplatin + paclitaxel ± bevacizumab | Drug | Placebo plus cisplatin/carboplatin + paclitaxel ± bevacizumab, Rulonilimab plus cisplatin/carboplatin + paclitaxel ± bevacizumab |
Primary outcome
Objective tumor response rate (ORR) assessed by RECIST1.1
Time frame: up to 2 years
Defined as the proportion of subjects who achieves a best overall response of CR or PR based on RECIST1.1
Progression Free Survival (PFS) assessed by RECIST1.1
Time frame: up to 2 years
Defined as the time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Overall Survival (OS)
Time frame: up to 2 years
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
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Time to Response (TTR)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rulonilimab and cisplatin/carboplatin + paclitaxel ± bevacizumab in people with Cervical Cancer, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response rate (ORR) assessed by RECIST1.1 (time frame: up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.