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

NCT05437692 | Unknown Phase 2

• 1 other identifier: B2022-213R
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate based on RECIST v1.1

  one year

Secondary Outcomes (4)

• adverse events

  two years

• DCR

  one year

• OS

  three years

• PFS

  two years

Study Arms (1)

zimberelimab plus concurrent radiotherapy and chemotherapy

EXPERIMENTAL

19 patients will treated with zimberelimab plus concurrent radiotherapy and chemotherapy

Drug: zimberelimab combined With concurrent radiotherapy and chemotherapy

Interventions

zimberelimab combined With concurrent radiotherapy and chemotherapy DRUG

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.

Also known as: GSL-010

zimberelimab plus concurrent radiotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \~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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (18)

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MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lin Genlai, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Genlai, MD

CONTACT

13816034376; lin.genlai@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: July 15, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)