Uterine Cervical Neoplasms, Recurrent; Uterine Cervical Neoplasms, Metastatic; Vulvar Neoplasms; Vaginal NeoplasmsPhase 2NCT07424664
A Single-arm, Multicenter Clinical Study of Becotatug Vedotin Combined With Zimberelimab in the Treatment of Recurrent and Metastatic Cervical Cancer, Vulvar Cancer and Vaginal Cancer
A Phase 2 study testing Becotatug Vedotin in combination with Zimberelimab in people with Uterine Cervical Neoplasms, Recurrent; Uterine Cervical Neoplasms, Metastatic; Vulvar Neoplasms; Vaginal Neoplasms, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a prospective, multicenter, single-arm clinical trial investigating Becotatug Vedotin in combination with Zimberelimab for the treatment of patients with recurrent and metastatic cervical cancer, vulvar cancer, and vaginal cancer. A total of 30 patients are expected to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Recurrent; Uterine Cervical Neoplasms, Metastatic; Vulvar Neoplasms; Vaginal Neoplasms
- What is being tested?
- Becotatug Vedotin in combination with Zimberelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2026to 15 Mar 2028
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must meet all of the following criteria to be eligible for enrollment:
- The subject has a full understanding of the study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).
- Female, aged 18 to 75 years (inclusive).
- Life expectancy ≥ 3 months, as assessed by the investigator.
- Histologically confirmed squamous cell carcinoma of the cervix, vagina, or vulva.
- Have received at least one line of standard therapy, which must have included platinum-based chemotherapy and an immunotherapy agent; prior lines of therapy ≤ 4.
Show all 12Show fewer
- ECOG performance status of 0 or 1.
- Presence of at least one measurable target lesion according to the RECIST 1.1 criteria.
- Adequate bone marrow function: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelets ≥ 90 × 10⁹/L, hemoglobin ≥ 90 g/L.
- Adequate hepatic and renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for subjects with liver metastases).
- Not pregnant or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to enrollment and agree to use an appropriate method of contraception from the time of signing the ICF until 6 months after the last study drug administration.
- Agrees to provide blood and histology samples.
Who cannot join
- A subject will be ineligible for study enrollment if they meet any of the following criteria:
- Known hypersensitivity or allergic reaction to any study drug or its components.
- Use of a strong CYP3A4 inducer (e.g., anticonvulsants [phenytoin, phenobarbital, carbamazepine], rifampicin, rifabutin, St. John's Wort) within 2 weeks prior to the first dose of study medication; or use of a strong CYP3A4 inhibitor (e.g., grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or a strong UGT1A1 inhibitor (e.g., atazanavir, gemfibrozil, indinavir) within 1 week prior to the first dose.
- Known central nervous system (CNS) metastases, meningeal metastases, spinal cord metastases or spinal cord compression.
- Currently having uncontrolled systemic diseases (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.), or psychiatric disorders/social conditions that would limit the subject's ability to comply with study requirements or provide written informed consent.
- Radiologically confirmed intestinal obstruction; or a medical history of the following diseases: inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis.
Show all 11Show fewer
- Active hepatitis B or hepatitis C infection (hepatitis B surface antigen positive with hepatitis B virus DNA > 1 × 10³ copies/mL; hepatitis C virus RNA > 1 × 10³ copies/mL).
- Human immunodeficiency virus (HIV) infection (positive HIV antibody test).
- Major surgery or severe trauma within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (as determined by the investigator).
- Pregnant or breastfeeding women; or women of childbearing potential who refuse to adopt effective contraceptive measures.
- Any other condition deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
Yao Jiang, 027-83262598, asdfjkl19@hotmail.com
About this study
This is a prospective, multicenter, single-arm clinical trial investigating Becotatug Vedotin in combination with Zimberelimab for the treatment of patients with recurrent and metastatic cervical cancer, vulvar cancer, and vaginal cancer. A total of 30 patients are expected to be enrolled. The study consists of a screening period (within 28 days), a treatment period, and a follow-up period (safety follow-up and survival follow-up). Trial treatment will continue until the patient has received Becotatug Vedotin for 1 year, or until disease progression, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first.
Subjects will sign the informed consent form and undergo baseline examinations during the screening period. Patients who meet the inclusion and exclusion criteria will enter the treatment period. All subjects will complete the relevant examinations specified in the protocol during treatment to observe safety, tolerability, and efficacy.
Read the detailed description
Recurrent and metastatic cervical, vulvar, and vaginal cancers represent a significant clinical challenge, with limited treatment options and poor prognosis for patients who have failed standard therapies. These malignancies are often driven by persistent human papillomavirus (HPV) infection, leading to immunosuppression and tumor immune evasion. While immune checkpoint inhibitors, such as anti-PD-1 antibodies, have shown some efficacy, response rates remain suboptimal, highlighting the need for more effective combination strategies.
Becotatug vedotin is an antibody-drug conjugate (ADC) that selectively delivers a potent cytotoxic payload to tumor cells expressing specific antigens, thereby inducing targeted cell death. Zimberelimab is a monoclonal antibody targeting the PD-1 checkpoint receptor, which functions to reactivate the body's immune system to recognize and attack cancer cells. The combination of these two agents is hypothesized to exert a synergistic anti-tumor effect, by directly eliminating tumor cells while simultaneously overcoming immunosuppression in the tumor microenvironment.
This trial will evaluate the safety, tolerability, and preliminary efficacy of this novel combination regimen.
- Being tested
- Becotatug Vedotin in combination with Zimberelimab
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence, Neoplasm Metastasis, Vulvar Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin in combination with ZimberelimabDrug
Vebicoratamab 2.0 mg/kg, administered intravenously on Day 1 of each cycle Sintilimab 240 mg, administered intravenously on Day 1 of each cycle Each treatment cycle is 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin in combination with Zimberelimab | Experimental | Subjects who are enrolled in the study and pass the investigator's screening will receive treatment according to the following regimen:
Becotatug Vedotin 2.0 mg/kg, administered intravenously on Day 1 of each cycle Zimberelimab 240 mg, administered intravenously on Day 1 of each cycle Each treatment cycle is 3 weeks. Treatment will continue until the first occurrence of any of the following events: disease progression, unacceptable toxicity, completion of 12 months of treatment, initiation of new anti-cancer therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances that the investigator deems necessitate treatment discontinuation. Receives: Drug: Becotatug Vedotin in combination with Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate of the treatment
The objective response rate of the treatment
Measured: Up to approximately 36 months
Secondary outcomes (3)
duration of response
Measured: Up to approximately 36 months
progression free survival
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Measured: Up to approximately 36 months
Overall Survival
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start11 Jun 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical Neoplasms, Recurrent; Uterine Cervical Neoplasms, Metastatic; Vulvar Neoplasms; Vaginal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Model description
- Becotatug Vedotin in combination with Zimberelimab
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guiling Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Guiling Li, Doctor, Principal investigator, Union Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424664
- Sponsor's protocol ID
- WB-PT-Cerv-Union01
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fu Z, Li S, Han S, Shi C, Zhang Y. Antibody drug conjugate: the "biological missile" for targeted cancer therapy. Signal Transduct Target Ther. 2022 Mar 22;7(1):93. doi: 10.1038/s41392-022-00947-7.
PubMed 35318309Xia L, Wang J, Wang C, Zhang Q, Zhu J, Rao Q, Cheng H, Liu Z, Yin Y, Ai X, Gulina K, Zheng H, Luo X, Chang B, Li L, Liu H, Li Y, Lou G, Zhou Q, Zhu Y, Xiao Z, Tong J, Wang K, Chen J, Wang X, Song L, Wei Z, Ye Y, Zhu J, Wu X. Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study. Int J Gynecol Cancer. 2023 Dec 4;33(12):1861-1868. doi: 10.1136/ijgc-2023-004705.
PubMed 37875323Lou B, Wei H, Yang F, Wang S, Yang B, Zheng Y, Zhu J, Yan S. Preclinical Characterization of GLS-010 (Zimberelimab), a Novel Fully Human Anti-PD-1 Therapeutic Monoclonal Antibody for Cancer. Front Oncol. 2021 Sep 15;11:736955. doi: 10.3389/fonc.2021.736955. eCollection 2021.
PubMed 34604074Schilder RJ, Blessing J, Cohn DE. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2005 Jan;96(1):103-7. doi: 10.1016/j.ygyno.2004.09.027.
PubMed 15589587Alberts DS, Blessing JA, Landrum LM, Warshal DP, Martin LP, Rose SL, Bonebrake AJ, Ramondetta LM. Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study. Gynecol Oncol. 2012 Dec;127(3):451-5. doi: 10.1016/j.ygyno.2012.09.008. Epub 2012 Sep 14.
PubMed 22986144Huang L, We Y, Chen F. Cadonilimab in advanced cervical cancer: the COMPASSION-16 trial. Lancet. 2025 Aug 2;406(10502):445-446. doi: 10.1016/S0140-6736(25)01226-7. No abstract available.
PubMed 40752905Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.
PubMed 37910822Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa1309748.
PubMed 24552320Liontos M, Kyriazoglou A, Dimitriadis I, Dimopoulos MA, Bamias A. Systemic therapy in cervical cancer: 30 years in review. Crit Rev Oncol Hematol. 2019 May;137:9-17. doi: 10.1016/j.critrevonc.2019.02.009. Epub 2019 Feb 28.
PubMed 31014518Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Clinical Study of Becotatug Vedotin Combined With Zimberelimab in the Treatment of Recurrent and Metastatic Cervical Cancer, Vulvar Cancer and Vaginal Cancer
- ClinicalTrials.gov ID
- NCT07424664
- Acronym / sponsor ID
- WB-PT-Cerv-Union01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 20 Feb 2026 (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, multicenter, single-arm clinical trial investigating Becotatug Vedotin in combination with Zimberelimab for the treatment of patients with recurrent and metastatic cervical cancer, vulvar cancer, and vaginal cancer. A total of 30 patients are expected to be enrolled. The study consists of a screening period (within 28 days), a treatment period, and a follow-up period (safety follow-up and survival follow-up). Trial treatment will continue until the patient has received Becotatug Vedotin for 1 year, or until disease progression, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first.
Subjects will sign the informed consent form and undergo baseline examinations during the screening period. Patients who meet the inclusion and exclusion criteria will enter the treatment period. All subjects will complete the relevant examinations specified in the protocol during treatment to observe safety, tolerability, and efficacy.
Detailed description
Recurrent and metastatic cervical, vulvar, and vaginal cancers represent a significant clinical challenge, with limited treatment options and poor prognosis for patients who have failed standard therapies. These malignancies are often driven by persistent human papillomavirus (HPV) infection, leading to immunosuppression and tumor immune evasion. While immune checkpoint inhibitors, such as anti-PD-1 antibodies, have shown some efficacy, response rates remain suboptimal, highlighting the need for more effective combination strategies.
Becotatug vedotin is an antibody-drug conjugate (ADC) that selectively delivers a potent cytotoxic payload to tumor cells expressing specific antigens, thereby inducing targeted cell death. Zimberelimab is a monoclonal antibody targeting the PD-1 checkpoint receptor, which functions to reactivate the body's immune system to recognize and attack cancer cells. The combination of these two agents is hypothesized to exert a synergistic anti-tumor effect, by directly eliminating tumor cells while simultaneously overcoming immunosuppression in the tumor microenvironment.
This trial will evaluate the safety, tolerability, and preliminary efficacy of this novel combination regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Becotatug Vedotin in combination with Zimberelimab
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin in combination with Zimberelimab | Experimental | Drug: Becotatug Vedotin in combination with ZimberelimabSubjects who are enrolled in the study and pass the investigator's screening will receive treatment according to the following regimen: Becotatug Vedotin 2.0 mg/kg, administered intravenously on Day 1 of each cycle Zimberelimab 240 mg, administered intravenously on Day 1 of each cycle Each treatment cycle is 3 weeks. Treatment will continue until the first occurrence of any of the following events: disease progression, unacceptable toxicity, completion of 12 months of treatment, initiation of new anti-cancer therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances that the investigator deems necessitate treatment discontinuation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject has a full understanding of the study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).
- Female, aged 18 to 75 years (inclusive).
- Life expectancy ≥ 3 months, as assessed by the investigator.
- Histologically confirmed squamous cell carcinoma of the cervix, vagina, or vulva.
- Have received at least one line of standard therapy, which must have included platinum-based chemotherapy and an immunotherapy agent; prior lines of therapy ≤ 4.
Key exclusion criteria (11 listed)
- A subject will be ineligible for study enrollment if they meet any of the following criteria:
- Known hypersensitivity or allergic reaction to any study drug or its components.
- Use of a strong CYP3A4 inducer (e.g., anticonvulsants [phenytoin, phenobarbital, carbamazepine], rifampicin, rifabutin, St. John's Wort) within 2 weeks prior to the first dose of study medication; or use of a strong CYP3A4 inhibitor (e.g., grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or a strong UGT1A1 inhibitor (e.g., atazanavir, gemfibrozil, indinavir) within 1 week prior to the first dose.
- Known central nervous system (CNS) metastases, meningeal metastases, spinal cord metastases or spinal cord compression.
- Currently having uncontrolled systemic diseases (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.), or psychiatric disorders/social conditions that would limit the subject's ability to comply with study requirements or provide written informed consent.
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 |
|---|---|---|
| Becotatug Vedotin in combination with ZimberelimabVebicoratamab 2.0 mg/kg, administered intravenously on Day 1 of each cycle Sintilimab 240 mg, administered intravenously on Day 1 of each cycle Each treatment cycle is 3 weeks. | Drug | Becotatug Vedotin in combination with Zimberelimab |
Primary outcome
The objective response rate of the treatment
Time frame: Up to approximately 36 months
The objective response rate of the treatment
3 secondary outcomes
duration of response
Time frame: Up to approximately 36 months
progression free survival
Time frame: Up to approximately 36 months
Overall Survival
Time frame: Up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 35318309Fu Z, Li S, Han S, Shi C, Zhang Y. Antibody drug conjugate: the "biological missile" for targeted cancer therapy. Signal Transduct Target Ther. 2022 Mar 22;7(1):93. doi: 10.1038/s41392-022-00947-7.
- Background: PubMed 37875323Xia L, Wang J, Wang C, Zhang Q, Zhu J, Rao Q, Cheng H, Liu Z, Yin Y, Ai X, Gulina K, Zheng H, Luo X, Chang B, Li L, Liu H, Li Y, Lou G, Zhou Q, Zhu Y, Xiao Z, Tong J, Wang K, Chen J, Wang X, Song L, Wei Z, Ye Y, Zhu J, Wu X. Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study. Int J Gynecol Cancer. 2023 Dec 4;33(12):1861-1868. doi: 10.1136/ijgc-2023-004705.
- Background: PubMed 34604074Lou B, Wei H, Yang F, Wang S, Yang B, Zheng Y, Zhu J, Yan S. Preclinical Characterization of GLS-010 (Zimberelimab), a Novel Fully Human Anti-PD-1 Therapeutic Monoclonal Antibody for Cancer. Front Oncol. 2021 Sep 15;11:736955. doi: 10.3389/fonc.2021.736955. eCollection 2021.
- Background: PubMed 15589587Schilder RJ, Blessing J, Cohn DE. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2005 Jan;96(1):103-7. doi: 10.1016/j.ygyno.2004.09.027.
- Background: PubMed 22986144Alberts DS, Blessing JA, Landrum LM, Warshal DP, Martin LP, Rose SL, Bonebrake AJ, Ramondetta LM. Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study. Gynecol Oncol. 2012 Dec;127(3):451-5. doi: 10.1016/j.ygyno.2012.09.008. Epub 2012 Sep 14.
- Background: PubMed 40752905Huang L, We Y, Chen F. Cadonilimab in advanced cervical cancer: the COMPASSION-16 trial. Lancet. 2025 Aug 2;406(10502):445-446. doi: 10.1016/S0140-6736(25)01226-7. No abstract available.
- Background: PubMed 37910822Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.
- Background: PubMed 24552320Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa1309748.
- Background: PubMed 31014518Liontos M, Kyriazoglou A, Dimitriadis I, Dimopoulos MA, Bamias A. Systemic therapy in cervical cancer: 30 years in review. Crit Rev Oncol Hematol. 2019 May;137:9-17. doi: 10.1016/j.critrevonc.2019.02.009. Epub 2019 Feb 28.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Individual participant dataSharing planned: Undecided
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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.
Guiling Li, Doctor principal investigator
Union Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
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 Becotatug Vedotin in combination with Zimberelimab in people with Uterine Cervical Neoplasms, Recurrent; Uterine Cervical Neoplasms, Metastatic; Vulvar Neoplasms; Vaginal Neoplasms, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 12 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
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?
Contact Yao Jiang, Doctor (027-83262598, asdfjkl19@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective response rate of the treatment (time frame: Up to approximately 36 months). 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 NCT07424664, which also lists 10 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 16 Jun 2026.