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AzTrials

Cervical CancerPhase 2NCT06039891

Nimotuzumab Plus Tislelizumab for Recurrent and Metastatic Cervical Cancer

A Phase 2 study testing Nimotuzumab、Tislelizumab in people with Cervical Cancer, run by Peking Union Medical College Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Nimotuzumab、Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
1 Oct 2023to 1 Oct 2027
Phase
Phase 2
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 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
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  • 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.

Who cannot join

  • 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；
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  • 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.

About this study

Official title: 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.

Read the 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).

Conditions
Cervical Cancer
Being tested
Nimotuzumab、Tislelizumab
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.

  • Nimotuzumab、TislelizumabDrug

    Also called Nimotuzumab, Tislelizumab plus radiotherapy

    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

Study groups in NCT06039891
Study groupRoleWhat they receive
Nimotuzumab, Tislelizumab groupExperimentalSubjects will receive Nimotuzumab 400 mg/time, intravenous injection, qw; Tislelizumab 200 mg/time, q3w until disease progression, intolerable toxicity, or 24 months of medication
Receives: Drug: Nimotuzumab、Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    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

    Measured: one year

Secondary outcomes (3)

  1. Objective response rate (ORR)

    ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1

    Measured: one year

  2. Median Overall survival（mOS）

    Overall survival from the start of study to the disease progression

    Measured: three years

  3. Adverse events (AEs)

    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

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start1 Oct 2023 (estimated)
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06039891
Sponsor's protocol ID
K4391
Status last verified
Sep 2023
First submitted
9 Sep 2023
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab、Tislelizumab in people with Cervical Cancer, run by Peking Union Medical College Hospital.

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 18 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: opening soon, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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?

Progression-free survival (PFS) (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06039891.

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 15 Sep 2023.

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