Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer

October 11, 2022 updated by: Shanghai Zhongshan Hospital

A Prospective, Single Arm, Phase II Clinical Study on the Treatment of Locally Advanced Cervical Cancer (Ⅱ B to Ⅳ a) With Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy

This is a prospective, single arm, phase II clinical study on the treatment of locally advanced cervical cancer (Ⅱ B to Ⅳ a) with Zimberelimab combined with concurrent radiotherapy and chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will include 19 patients with locally advanced cervical cancer to explore the efficacy and safety of Zimberelimab in combination with concurrent radiotherapy for them.

Study Type

Interventional

Enrollment (Anticipated)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
        • Principal Investigator:
          • Lin Genlai, MD

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • FIGO 2018 stage IIB to IVA cervical cancer;
  • Cervical squamous cell carcinoma, cervical adenocarcinoma or cervical adenosquamous carcinoma confirmed by histology;
  • Have not received any radiotherapy for cervical cancer in the past, and have not received immunotherapy;
  • Have measurable lesions (according to RECIST v1.1 standard);
  • ECOG score: 0 ~ 1;
  • 18~75 years old (calculated on the day of signing the informed consent);
  • The estimated survival period exceeds 6 months;
  • Before enrollment, try to provide enough tumor tissue samples (archived or fresh biopsy samples) to evaluate and confirm the expression of PD-L1 and to detect other biomarkers; Considering the accessibility of clinical specimens, there is no mandatory requirement for specimens;
  • Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within ● months after the end of the study; Within 7 days before the study was enrolled, the serum or urine pregnancy test was negative, and must be non lactating patients;
  • For the full organ function defined in the protocol, the test samples must be collected within 7 days before the start of the study treatment;
  • The patients volunteered to join the study and signed the informed consent form.

Exclusion Criteria:

  • The subjects have other histological subtypes except those permitted by inclusion criteria 2;
  • Bilateral hydronephrosis, unless at least one side has been implanted with a stent or solved by a positioned nephrostomy;
  • Those who are allergic to gadolinium, a common non-ionic CT contrast agent and a magnetic resonance contrast agent
  • Have anatomical structure or tumor geometry or any other reasons or contraindications that cannot be treated with intracavitary brachytherapy or intracavitary and implantable brachytherapy;
  • Severe hypersensitivity (≥ grade 3) to cepalimumab and / or any of its excipients;
  • Participated in or had participated in clinical trials within 4 weeks before randomization;
  • Have been vaccinated or will be vaccinated with live vaccine within 30 days before the first study treatment;
  • Have received systemic immune stimulant, colony stimulating factor, interferon, interleukin and vaccine combination treatment within 6 weeks or 5 half lives (whichever is shorter) before the first administration;
  • Within 7 days before the first administration, the patient has been diagnosed with immune deficiency or is receiving chronic systemic steroid therapy (the dose exceeds 10mg prednisone equivalent per day) or any other form of immunosuppressive therapy;
  • Active autoimmune diseases requiring systemic treatment during the past two years (such as the use of disease regulating drugs, corticosteroids or immunosuppressive drugs);
  • Have a history of (non infectious) pneumonia requiring steroid treatment or currently have (non infectious) pneumonia;
  • Active infection requiring systematic treatment;
  • Known HIV infection history;
  • Known hepatitis B (defined as HBsAg reactivity) or known active hepatitis C virus (defined as detection of HCV RNA [qualitative]) infection history;
  • Known history of active tuberculosis (TB; Mycobacterium tuberculosis);
  • Received allogeneic tissue / solid organ transplantation;
  • Central nervous system metastasis such as tumor brain metastasis;
  • Patients with uncontrolled hydrothorax and ascites;
  • Patients with movement disorders such as pathological fractures caused by tumor bone metastasis;
  • Insufficient hematopoietic function of bone marrow (without blood transfusion within 14 days):
  • Abnormal liver:
  • Abnormal kidney:
  • Risk of bleeding:
  • Cardiovascular and cerebrovascular abnormalities:

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: zimberelimab plus concurrent radiotherapy and chemotherapy
19 patients will treated with zimberelimab plus concurrent radiotherapy and chemotherapy
Drug: zimberelimab combined With concurrent radiotherapy and chemotherapy
zimberelimab: 240 mg Q2W Intravenous drip，The maximum duration of medication shall not exceed one years; chemotherapy: Starting from the first week of radiotherapy and chemotherapy, cisplatin 40mg/m2 and paclitaxel 35mg/m2 were given intravenously for 30-60min; Radiotherapy: intensity modulated radiation therapy (IMRT) was used for external irradiation. The total dose of pelvic cavity and lymph drainage planning target area (PTV) was 45-50 gy/25-28f. The metastatic lymph nodes should be able to supplement or synchronously push 10-15 Gy; The internal irradiation was started within 2 weeks after the end of external irradiation treatment. The image-guided three-dimensional brachytherapy was used, and 30-40gy was added to make the total dose of point a reach 80-85 Gy, twice a week, 5-6gy each time. All radiotherapy was completed within 8 weeks.
Other Names:
  • GSL-010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: one year
Objective response rate based on RECIST v1.1
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: two years
adverse events evaluation based on NCI-CTCAE 5.0
two years
DCR
Time Frame: one year
Disease control rate evaluation based on RECIST v1.1
one year
OS
Time Frame: three years
overall survival time
three years
PFS
Time Frame: two years
Progression free survival time
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Lin Genlai, MD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 15, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2022-213R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared.

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.

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