Advanced Cervical CancerPhase 2NCT04590599
A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy
A Phase 2 study testing IBI310 and Sintilimab in people with Advanced Cervical Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 2 sites in China.
Trial summary
This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Cervical Cancer
- What is being tested?
- IBI310 and Sintilimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 2 sitesChina
- Study dates
- 8 Dec 2020to 20 Nov 2023
- 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
- The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
- Aged ≥18 years and ≤75 years.
- Diagnosed with cervical cancer by histology/cytology.
- Patients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).
- The subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue).
Who cannot join
- Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.
- Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage (patients with effusion that does not require drainage or patients with no significant increase in the effusion within 3 days after stopping drainage can be selected).
- Patients who are planning to undergo or have previously received organ or bone marrow transplantation.
- Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 200 IU/ml or 103 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
- Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases who do not need treatment with glucocorticoids, anticonvulsants or mannitol after radiotherapy can be enrolled.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Innovent Biologics, Inc.
Suzhou, Jiangsu, 215123
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital）
Zhenjiang
About this study
Official title: A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy
This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy
- Conditions
- Advanced Cervical Cancer
- Being tested
- IBI310, Placebo, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI310Drug
IBI310 3 mg/kg,Q3W, for a total of 4 cycles
PlaceboDrug
Placebo Q3W, for a total of 4 cycles
SintilimabDrug
Also called IBI308
Sintilimab 200mg,Q3W
| Study group | Role | What they receive |
|---|---|---|
| IBI310+Sintilimab | Experimental | IBI310+Sintilimab Receives: Drug: IBI310; Drug: Sintilimab |
| Placebo+Sintilimab | Active comparator | Placebo+Sintilimab Receives: Drug: Placebo; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1
Measured: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Objective response rate (ORR)
ORR assessed by the investigator according to the RECIST V1.1
Measured: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Secondary outcomes (1)
Disease Control Rate（DCR）
DCR assessed by the investigator and IRRC according to the RECIST V1.1
Measured: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start8 Dec 2020
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590599
- Sponsor's protocol ID
- CIBI310E201
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li H, Xu Y, Jiao X, Xu Q, Peng Z, Tang Y, Zhang J, Huang B, Shen Y, Chang B, Xia B, Duan W, Wang D, Zhu L, An R, Zhang G, Tang Y, Huang J, Qiu H, Wang L, Huang Y, Li G, Qian J, Sun L, Zheng H, Lou G, Zhang Y, Chen Y, Lu L, Cheng Y, Liu J, Zhao W, Ji J, He A, Wang K, Yu G, Zhu H, Ma C, Yuan J, Wang X, Zhang H, Ma X, Cai C, Yin K, Xie H, Wang Y, Wang S, Li L, Zhou H, Wang J, Zhu J, Ma D, Gao Q. IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial. Med. 2025 May 9;6(5):100573. doi: 10.1016/j.medj.2024.100573. Epub 2025 Jan 18.
PubMed 39827881
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT04590599
- Acronym / sponsor ID
- CIBI310E201
- Conditions
- Advanced Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 19 Oct 2020 (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 randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI310+Sintilimab | Experimental | Drug: IBI310, Drug: SintilimabIBI310+Sintilimab |
| Placebo+Sintilimab | Active comparator | Drug: Placebo, Drug: SintilimabPlacebo+Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
- Aged ≥18 years and ≤75 years.
- Diagnosed with cervical cancer by histology/cytology.
- Patients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).
- The subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue).
Key exclusion criteria (5 listed)
- Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.
- Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage (patients with effusion that does not require drainage or patients with no significant increase in the effusion within 3 days after stopping drainage can be selected).
- Patients who are planning to undergo or have previously received organ or bone marrow transplantation.
- Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 200 IU/ml or 103 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
- Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases who do not need treatment with glucocorticoids, anticonvulsants or mannitol after radiotherapy can be enrolled.
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 |
|---|---|---|
| IBI310IBI310 3 mg/kg,Q3W, for a total of 4 cycles | Drug | IBI310+Sintilimab |
| PlaceboPlacebo Q3W, for a total of 4 cycles | Drug | Placebo+Sintilimab |
| SintilimabAlso: IBI308Sintilimab 200mg,Q3W | Drug | IBI310+Sintilimab, Placebo+Sintilimab |
Primary outcome
Objective response rate (ORR)
Time frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Objective response rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1
Objective response rate (ORR)
Time frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
ORR assessed by the investigator according to the RECIST V1.1
1 secondary outcome
Disease Control Rate（DCR）
Time frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 39827881Li H, Xu Y, Jiao X, Xu Q, Peng Z, Tang Y, Zhang J, Huang B, Shen Y, Chang B, Xia B, Duan W, Wang D, Zhu L, An R, Zhang G, Tang Y, Huang J, Qiu H, Wang L, Huang Y, Li G, Qian J, Sun L, Zheng H, Lou G, Zhang Y, Chen Y, Lu L, Cheng Y, Liu J, Zhao W, Ji J, He A, Wang K, Yu G, Zhu H, Ma C, Yuan J, Wang X, Zhang H, Ma X, Cai C, Yin K, Xie H, Wang Y, Wang S, Li L, Zhou H, Wang J, Zhu J, Ma D, Gao Q. IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial. Med. 2025 May 9;6(5):100573. doi: 10.1016/j.medj.2024.100573. Epub 2025 Jan 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI310 and Sintilimab in people with Advanced Cervical Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 2 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.). The study lists 2 primary outcomes in all. 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 NCT04590599, which also lists 1 linked publication.
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 18 Dec 2023.