- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06039891
Nimotuzumab Plus Tislelizumab for Recurrent and Metastatic Cervical Cancer
September 9, 2023 updated by: Lei Li, Peking Union Medical College Hospital
A Single-arm, Single-center, Prospective, Phase II Study of Nimotuzumab, Tislelizumab Plus Radiotherapy for Recurrent and Metastatic Cervical Cancer
Patients with recurrent or metastatic cervical cancer have very poor prognosis.
For eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods.
Epidermal growth factor receptor (EGFR) is overexpressed in cervical cancer cells, anti-EGFR therapy maybe an ideal target for the treatment of cervical cancer.
This study aims to discover the progression-free survival of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor [EGFR] IgG1 humanized monoclonal antibody) 、Tislelizumab and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Nimotuzumab, is a humanized antibody recognizing with high affinity the epidermal growthfactor (EGF-R),has shown promising efficacy and tolerable toxicity in the cervical cancer.
In this study, patients with recurrent or metastatic cervical cancer, will be included in this study according to the prescribed criteria in the protocal.
Nimotuzumab 400 mg/time, intravenous injection, qw; Tislelizumab 200 mg/time, q3w until disease progression, intolerable toxicity, or 24 months of medication.
Assess objective response rate; progression-free survival; median overall survival and safety ( adverse event).
Study Type
Interventional
Enrollment (Estimated)
55
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age≥18;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
- Have recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix;
- Oligometastases and Oligo-recurrence( number of metastatic organs ≤3, and the total number of metastases ≤5), with indications for radiotherapy, and which has not been treated with systemic chemotherapy;
- At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1;
- Anticipative survival period of 3 months or more;
- Have adequate organ function as indicated by the following laboratory values: (1) Hematological:Absolute neutrophil count (ANC)≥1.5×109/L;Platelets(PLT)≥90×109/L;Hemoglobin(Hb)≥90 g/L; (2) Hepatic:Serum total bilirubin (TBIL)≤2.5×ULN;ALT 和 AST≤2×ULN; (3) Renal:BUN 和 Cr ≤ 1.5×ULN;
- Cardiac ultrasound:LVEF≥50%;
- A WOCBP who has a positive blood pregnancy test within 72 hours prior to randomization(Postmenopausal women who have had amenorrhea for at least 12 months are considered infertile, and women who are known to have received Tubal ligation do not require a pregnancy test);
- For subjects who were not menopausal or had not undergone surgical sterilization, consent to abstinence or use of an effective contraceptive method was given during treatment and at least 5 months after the last administration of the drug during study treatment;
- Volunteer to join the study, sign informed consent, have good compliance and willing to cooperate with the follow-up.
Exclusion Criteria:
- Patients who have received prior therapy with an anti-EGFR an anti-PD-1, anti-PD-L1 agent; Has a contraindication or hypersensitivity to Macromolecular protein preparationsany and component of Nimotuzumab and Tislelizumab
- Other malignancies diagnosed within 5 years before the first dose, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin and papillary thyroid carcinoma;
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy, prior therapy with other targeted therapy and any anti-vascular endothelial growth factor (VEGF) drug. Other anti-tumor treatments not included in this trial protocol;
- Patients who are pregnant or nursing. Patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least five months after completion of this study.
- Patients with recto-vaginal fistula,vesicovaginal fistula, uncontrolled vaginal bleeding and no underlying process leading to fistula;
- Major surgical procedure unrelated to cervical cancer,and has not recovered adequately from toxicity and/or complications from surgery within 4 weeks before enrollment;
- Has a known history of human immunodeficiency virus (HIV) infection,or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;
- Uncontrolled hypertension , cardiac arrhythmia and pulmonary disease.Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Has known active Central Nervous System (CNS)metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable more than 2 weeks. Known brain metastases are considered active, if any of the following criteria are: There were measurable lesions outside the central nervous system, no metastases to meninges, midbrain, pons, cerebellum, medulla oblongata or spinal cord, no previous history of intracranial hemorrhage, and steroid therapy was discontinued 14 days before the first dose of study drug.
- Patients with clinical signs or fluids of pleural effusion, ascites, or pericardial effusion requiring drainage (required or not significantly increased within 3 days of discontinuation of drainage) may be eligible;
- Any previous arterial thrombosis, thrombosis, or ischaemia, such as myocardial infarction, unstable angina, cerebrovascular accident, etc., occurred in the previous 6 months.A history of deep venous thrombosis or any other serious thromboembolism (implanted venous port or catheter-derived thrombosis, superficial venous thrombosis, or thromboembolic stability after conventional therapy were not considered as serious" thromboembolism" during the first 3 months of enrollment";
- Cancer thrombus in the portal vein involves both the main and right branches of the portal vein, or both the main and the superior mesenteric and inferior vena cava thrombus; the superior vena cava thrombus and the superior vena cava syndrome;
- Tumour involvement of vital peripheral organs or vessels (such as the great vessels of the mediastinum, superior vena cava, inferior vena cava, abdominal aorta, iliac vessels, trachea, esophagus, etc.) or risk of esophageal-tracheal or esophageal pleural fistula;
- History of interstitial pneumonia, pharmacologic pneumonia, radiation pneumonia, idiopathic pneumonia, or active pneumonia;
- Severe infection in active state or under clinical control.Severe infections occurred within 4 weeks before the first dose, including but not limited to hospitalization for infection, bacteremia, or complications of severe pneumonia.
- Inability to perform internal exposure therapy by the Investigator's assessment;
- Patients who do not understand the requirements of the trial or may not comply with them.
- Participants were identified as having any medical, psychiatric, or other condition or condition that may adversely affect their safety or the reliability of study data.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nimotuzumab, Tislelizumab group
Subjects will receive Nimotuzumab 400 mg/time, intravenous injection, qw; Tislelizumab 200 mg/time, q3w until disease progression, intolerable toxicity, or 24 months of medication
|
Subjects will receive Nimotuzumab 400 mg/time, intravenous injection, qw; Tislelizumab 200 mg/time, q3w until disease progression, intolerable toxicity, or 24 months of medication
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: one year
|
Progression-free survival is defined as the time from the start of treatment with caldonirimab and nimotuzumab until the first documentation of disease progression or death due to any cause, whichever occurs first
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: one year
|
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1
|
one year
|
Median Overall survival(mOS)
Time Frame: three years
|
Overall survival from the start of study to the disease progression
|
three years
|
Adverse events (AEs)
Time Frame: three years
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2027
Study Registration Dates
First Submitted
September 9, 2023
First Submitted That Met QC Criteria
September 9, 2023
First Posted (Actual)
September 15, 2023
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 9, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Nimotuzumab
- Tislelizumab
Other Study ID Numbers
- K4391
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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