Locally Advanced Cervical CancerPhase 2NCT05437692
Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer
A Phase 2 study testing zimberelimab combined With concurrent radiotherapy and chemotherapy in people with Locally Advanced Cervical Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- zimberelimab combined With concurrent radiotherapy and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
Show all 24Show fewer
- 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:
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan hospital
Shanghai, Shanghai Municipality, 200032
Clinical trial institution Office of Zhongshan Hospital, MD, 021-31587861, sun.wei5@zs-hospital.sh.cn
Lin Genlai, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- zimberelimab combined With concurrent radiotherapy and chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zimberelimab combined With concurrent radiotherapy and chemotherapyDrug
Also called GSL-010
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.
| Study group | Role | What they receive |
|---|---|---|
| zimberelimab plus concurrent radiotherapy and chemotherapy | Experimental | 19 patients will treated with zimberelimab plus concurrent radiotherapy and chemotherapy Receives: Drug: zimberelimab combined With concurrent radiotherapy and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate based on RECIST v1.1
Measured: one year
Secondary outcomes (4)
adverse events
adverse events evaluation based on NCI-CTCAE 5.0
Measured: two years
DCR
Disease control rate evaluation based on RECIST v1.1
Measured: one year
OS
overall survival time
Measured: three years
PFS
Progression free survival time
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start15 Jul 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Genlai, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437692
- Sponsor's protocol ID
- B2022-213R
- Status last verified
- Jun 2022
- First submitted
- 24 Jun 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Publications
Wright 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.
PubMed 31188324Arbyn 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.
PubMed 31812369Koh 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.
PubMed 30659131Kokka 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.
PubMed 25847525Pakish 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.
PubMed 28840453Mandal 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.
PubMed 27107038Bonneville 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.
PubMed 29850653Shao C, Li G, Huang L, Pruitt S, Castellanos E, Frampton G, Carson KR, Snow T, Singal G, Fabrizio D, Alexander BM, Jin F, Zhou W. Prevalence of High Tumor Mutational Burden and Association With Survival in Patients With Less Common Solid Tumors. JAMA Netw Open. 2020 Oct 1;3(10):e2025109. doi: 10.1001/jamanetworkopen.2020.25109.
PubMed 33119110Liu Y, Wu L, Tong R, Yang F, Yin L, Li M, You L, Xue J, Lu Y. PD-1/PD-L1 Inhibitors in Cervical Cancer. Front Pharmacol. 2019 Feb 1;10:65. doi: 10.3389/fphar.2019.00065. eCollection 2019.
PubMed 30774597Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2.
PubMed 29095678Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.
PubMed 30943124Tamura K, Hasegawa K, Katsumata N, Matsumoto K, Mukai H, Takahashi S, Nomura H, Minami H. Efficacy and safety of nivolumab in Japanese patients with uterine cervical cancer, uterine corpus cancer, or soft tissue sarcoma: Multicenter, open-label phase 2 trial. Cancer Sci. 2019 Sep;110(9):2894-2904. doi: 10.1111/cas.14148. Epub 2019 Sep 3.
PubMed 31348579Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, Lopez-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.
PubMed 31487218Santin AD, Deng W, Frumovitz M, Buza N, Bellone S, Huh W, Khleif S, Lankes HA, Ratner ES, O'Cearbhaill RE, Jazaeri AA, Birrer M. Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002). Gynecol Oncol. 2020 Apr;157(1):161-166. doi: 10.1016/j.ygyno.2019.12.034. Epub 2020 Jan 7.
PubMed 31924334Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.
PubMed 34534429
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05437692
- Acronym / sponsor ID
- B2022-213R
- Conditions
- Locally Advanced Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zimberelimab plus concurrent radiotherapy and chemotherapy | Experimental | Drug: zimberelimab combined With concurrent radiotherapy and chemotherapy19 patients will treated with zimberelimab plus concurrent radiotherapy and chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zimberelimab combined With concurrent radiotherapy and chemotherapyAlso: GSL-010zimberelimab: 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. | Drug | zimberelimab plus concurrent radiotherapy and chemotherapy |
Primary outcome
ORR
Time frame: one year
Objective response rate based on RECIST v1.1
4 secondary outcomes
adverse events
Time frame: two years
DCR
Time frame: one year
OS
Time frame: three years
PFS
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Results publication: PubMed 31188324Wright 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.
- Results publication: PubMed 31812369Arbyn 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.
- Results publication: PubMed 30659131Koh 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.
- Results publication: PubMed 25847525Kokka 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.
- Results publication: PubMed 28840453Pakish 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.
- Results publication: PubMed 27107038Mandal 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.
- Results publication: PubMed 29850653Bonneville 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.
- Results publication: PubMed 33119110Shao C, Li G, Huang L, Pruitt S, Castellanos E, Frampton G, Carson KR, Snow T, Singal G, Fabrizio D, Alexander BM, Jin F, Zhou W. Prevalence of High Tumor Mutational Burden and Association With Survival in Patients With Less Common Solid Tumors. JAMA Netw Open. 2020 Oct 1;3(10):e2025109. doi: 10.1001/jamanetworkopen.2020.25109.
- Results publication: PubMed 30774597Liu Y, Wu L, Tong R, Yang F, Yin L, Li M, You L, Xue J, Lu Y. PD-1/PD-L1 Inhibitors in Cervical Cancer. Front Pharmacol. 2019 Feb 1;10:65. doi: 10.3389/fphar.2019.00065. eCollection 2019.
- Results publication: PubMed 29095678Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2.
- Results publication: PubMed 30943124Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.
- Results publication: PubMed 31348579Tamura K, Hasegawa K, Katsumata N, Matsumoto K, Mukai H, Takahashi S, Nomura H, Minami H. Efficacy and safety of nivolumab in Japanese patients with uterine cervical cancer, uterine corpus cancer, or soft tissue sarcoma: Multicenter, open-label phase 2 trial. Cancer Sci. 2019 Sep;110(9):2894-2904. doi: 10.1111/cas.14148. Epub 2019 Sep 3.
- Individual participant dataSharing planned: No. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Genlai, MD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zimberelimab combined With concurrent radiotherapy and chemotherapy in people with Locally Advanced Cervical Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
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 24 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: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Genlai, MD (13816034376, lin.genlai@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (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 NCT05437692, which also lists 18 linked publications.
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 12 Oct 2022.