Clinical trial · Interventional
Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer
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
NCT05437692CI-TRIAL-00061413unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zimberelimab combined With concurrent radiotherapy and chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- zimberelimab plus concurrent radiotherapy and chemotherapy
- description
- 19 patients will treated with zimberelimab plus concurrent radiotherapy and chemotherapy
- interventionNames
- Drug: zimberelimab combined With concurrent radiotherapy and chemotherapy
Primary outcomes (1)
- measure
- ORR
- timeFrame
- one year
- description
- Objective response rate based on RECIST v1.1
Secondary outcomes (4)
- measure
- adverse events
- timeFrame
- two years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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:
References
Publications (18)
- RESULTWright JD, Matsuo K, Huang Y, Tergas AI, Hou JY, Khoury-Collado F, St Clair CM, Ananth CV, Neugut AI, Hershman DL. Prognostic Performance of the 2018 International Federation of Gynecology and Obstetrics Cervical Cancer Staging Guidelines. Obstet Gynecol. 2019 Jul;134(1):49-57. doi: 10.1097/AOG.0000000000003311. PMID 31188324
- RESULTArbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4. PMID 31812369
- RESULTKoh WJ, Abu-Rustum NR, Bean S, Bradley K, Campos SM, Cho KR, Chon HS, Chu C, Clark R, Cohn D, Crispens MA, Damast S, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, Han E, Huh WK, Lurain JR, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Ueda S, Wyse E, Yashar CM, McMillian NR, Scavone JL. Cervical Cancer, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jan;17(1):64-84. doi: 10.6004/jnccn.2019.0001. PMID 30659131
- RESULTKokka F, Bryant A, Brockbank E, Powell M, Oram D. Hysterectomy with radiotherapy or chemotherapy or both for women with locally advanced cervical cancer. Cochrane Database Syst Rev. 2015 Apr 7;(4):CD010260. doi: 10.1002/14651858.CD010260.pub2. PMID 25847525
- RESULTPakish JB, Jazaeri AA. Immunotherapy in Gynecologic Cancers: Are We There Yet? Curr Treat Options Oncol. 2017 Aug 24;18(10):59. doi: 10.1007/s11864-017-0504-y. PMID 28840453
- RESULTMandal R, Chan TA. Personalized Oncology Meets Immunology: The Path toward Precision Immunotherapy. Cancer Discov. 2016 Jul;6(7):703-13. doi: 10.1158/2159-8290.CD-16-0146. Epub 2016 Apr 22. PMID 27107038
- RESULTBonneville R, Krook MA, Kautto EA, Miya J, Wing MR, Chen HZ, Reeser JW, Yu L, Roychowdhury S. Landscape of Microsatellite Instability Across 39 Cancer Types. JCO Precis Oncol. 2017;2017:PO.17.00073. doi: 10.1200/PO.17.00073. Epub 2017 Oct 3.