Cervical CancerPhase 2NCT05817214
Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer
A Phase 2 study testing Cadonilimab, Anlotinib and Granulocyte-Macrophage Colony-Stimulating Factor in people with Cervical Cancer, run by Zhongnan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Cadonilimab, Anlotinib and Granulocyte-Macrophage Colony-Stimulating Factor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2023to 28 Feb 2027
- 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
- Obtain informed consent signed by the patient or their legal representative;
- Female patients aged ≥18 and ≤75 years old;
- ECOG PS score of 0-1;
- Expected survival period ≥6 months;
- Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma originating from the cervix;
- Can provide tumor tissue specimens archived within 2 years or willing to undergo tumor tissue biopsy to provide fresh specimens for further testing;
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- At least one evaluable lesion meeting the criteria of RECIST 1.1;
- Have only received standard first-line systemic treatment in the past: (1) If first-line treatment does not include immunotherapy, failure of first-line treatment is sufficient (for patients who have previously achieved cure, any number of neoadjuvant or adjuvant chemotherapy cycles do not count towards the line count, unless disease progression occurs within 3 months after ≥3 cycles of neoadjuvant/adjuvant chemotherapy; for persistent disease, ≥2 cycles of previous chemotherapy can be counted as one line, otherwise not counted); (2) If first-line treatment includes immunotherapy, clinical benefit must occur after first-line treatment, namely partial or complete tumor remission, with the duration of efficacy lasting more than 6 months.
- Sitting blood pressure in a resting state is below the normal high value (<140/90 mmHg), or 24-hour dynamic blood pressure monitoring average blood pressure is below the normal high value (<140/90 mmHg), regardless of whether antihypertensive drugs are being taken orally;
- Hematological indicators meet the following criteria (not transfused or administered hematopoietic growth factor drugs within the past 7 days): white blood cell count (WBC) ≥3.5×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L;
- Liver function indicators meet the following criteria: ALT and AST ≤2.5 times the upper limit of normal (ULN), bilirubin ≤1.5×ULN, albumin ≥35g/L;
- Coagulation function indicators meet the following criteria (not receiving anticoagulant or hemostatic drug therapy): PT and APTT ≤1.5×ULN, while INR ≤1.5 ULN;
- Renal function indicators meet the following criteria: blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN, urinary protein <2+ or 24-hour urinary protein quantification <1g;
- Women of childbearing age must undergo serum pregnancy testing within 7 days before initial medication, with negative results, and not be lactating. Female subjects of childbearing age must agree to use effective contraception during the study period and within 180 days after the last dose of the study drug;
- Good compliance.
Who cannot join
- Translation:
- Any unstable systemic diseases, including but not limited to active infections within 4 weeks (defined as fever exceeding 38.5°C, evidence of bacteremia, or evidence of infectious changes in the heart, brain, kidneys, lungs, liver, and intestines), circulatory accidents within 6 months (malignant hypertensive crisis, myocardial infarction, severe/unstable angina, heart failure above NYHA class 2, clinically significant supraventricular or ventricular arrhythmias, or cerebral vascular accidents not yet recovered from or resulting in severe sequelae), uncontrolled type 2 diabetes (fasting blood glucose >11.1 mmol/L or glycated hemoglobin >8%), and pulmonary insufficiency (any cause leading to decreased lung function, defined as FEV1/FVC <70%, FEV1 <80% of predicted value).
- History of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune liver diseases, systemic vasculitis, scleroderma, dermatomyositis, autoimmune hemolytic anemia;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the assay) or combined hepatitis B and hepatitis C infection;
- History of attenuated live vaccine administration within 28 days before the first dose of the study drug or expected attenuated live vaccine administration during the study period;
- Tumor invasion of major blood vessels on imaging or investigator judgment indicating a high risk of tumor invasion of important vessels causing fatal bleeding or other diseases with a high risk of severe bleeding;
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- Previous treatment with anlotinib or cadonilimab;
- Evidence of active tuberculosis infection within the past year before screening;
- Diagnosis of any other malignant tumors, adequately treated basal cell carcinoma or squamous cell skin carcinoma, or cervical carcinoma in situ within 5 years before entering the study;
- Major surgery within 28 days before randomization (tissue biopsy for diagnostic purposes and insertion of a central venous catheter via percutaneous puncture are allowed);
- Active venous or arterial thromboembolic events within 6 months before randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism;
- Previous or planned allogeneic bone marrow or solid organ transplantation;
- Clinically significant intestinal obstruction, occurrence of intestinal repair, intestinal anastomosis, intestinal diversion, or enterocutaneous fistula for any reason at any time;
- Participants who experienced symptoms of hemoptysis within 2 months before entering the study and had a maximum daily hemoptysis volume of approximately ≥2.5 mL. Participants who experienced significant bleeding symptoms or had a clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood test ++ and above, or vasculitis, within 3 months before entering the study; known hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, splenic hyperfunction, etc.;
- Visible hematuria or other evidence of active urinary system bleeding;
- Currently receiving thrombolysis or requiring long-term anticoagulant therapy with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
- Known allergy to anlotinib, cadonilimab or any of their excipients;
- Participation in any other drug clinical studies within the previous 4 weeks before randomization or within 5 half-lives of the last study drug administration;
- History of substance abuse, alcoholism, or drug addiction;
- Coexisting severe cognitive impairment and inability to achieve stable mental status;
- As judged by the investigator, patients may have other factors that could lead to premature termination of the study, such as other serious illnesses or severe laboratory abnormalities, or factors affecting the safety of the participants or the collection of trial data and samples due to family or social reasons, etc.
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
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Shaoxing Sun, +08613871286154, sunshaoxing@whu.edu.cn
Hui Qiu, +08618986255160, qiuhuiznyy@whu.edu.cn
About this study
Official title: Cadonilimab Plus Anlotinib for Recurrent, Metastasis or Persistent Cervical Cancer
The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. The main questions it aims to answer are:
- The efficacy of this combination in R/M/P CC;
- The tolerance of this combination in R/M/P CC;
- Possible biomarker of treatment response for this combination.
Participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.
Read the detailed description
The prognosis was poor for recurrent, metastasis and persistent cervical cancer especially for those who had multiple lesions and history of previous radiation therapy. KEYNOTE-826 Study demonstrated survival benefit of adding pembrolizumab into the standard first-line treatment for cervical cancer. Here we designed a exploratory clinical study to test a new treatment combination including cadonilimab and anlotinib in recurrent, metastasis and persistent cervical cancer. All participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (8mg) orally in day 1 to day 14, then take a 7-days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.
- Conditions
- Cervical Cancer
- Being tested
- Cadonilimab, Anlotinib, Granulocyte-Macrophage Colony-Stimulating Factor
- Keywords
- Cervical Cancer, Cadonilimab, Anlotinib, Granulocyte-macrophage colony-stimulating factor, Immunotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Also called AK104
All Participants will receive cadonilimab of 10mg/kg every three weeks at day 1
AnlotinibDrug
Also called AL001
All Participants will take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break.
Granulocyte-Macrophage Colony-Stimulating FactorDrug
All Participants will have subcutaneously injection of granulocyte-macrophage colony-stimulating factor from day 1 to day 14, then take a 7 days break.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | This trial has a single treatment arm. All participants will receive small treatment including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor in this arm Receives: Drug: Cadonilimab; Drug: Anlotinib; Drug: Granulocyte-Macrophage Colony-Stimulating Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Rate of participants with complete response plus partial response as best response in the intent to treatment group according to RECIST 1.1
Measured: up to 2 years
Secondary outcomes (5)
Rate and grade of adverse events
The incidence of adverse events and severity graded according to CTCAE 5.0
Measured: From enrollment to 90 days after last treatment of all subjects
Disease control rate
Rate of participants with complete response plus partial response plus stable disease as best response in the intent to treatment group according to RECIST 1.1
Measured: up to 2 years
Duration of Response
Time period from first response to first progression
Measured: Up to 2 years
Progression free survival rate
Proportion of participants without tumor recurrence or death
Measured: Up to 2 years
Overall survival rate
Proportion of survival participants
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start16 Feb 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Akeso Biopharma Co., Ltd.
- Responsible party
- Principal investigator, Hui Qiu, Zhongnan Hospital
- Investigators
- Hui Qiu, Ph.D., Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817214
- Sponsor's protocol ID
- CC-01
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadonilimab Plus Anlotinib for Recurrent, Metastasis or Persistent Cervical Cancer
- ClinicalTrials.gov ID
- NCT05817214
- Acronym / sponsor ID
- CC-01
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Cadonilimab, Anlotinib, Granulocyte-macrophage colony-stimulating factor, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Collaborators
- Akeso Biopharma Co., Ltd.
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Apr 2023 (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.
The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. The main questions it aims to answer are:
- The efficacy of this combination in R/M/P CC;
- The tolerance of this combination in R/M/P CC;
- Possible biomarker of treatment response for this combination.
Participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.
Detailed description
The prognosis was poor for recurrent, metastasis and persistent cervical cancer especially for those who had multiple lesions and history of previous radiation therapy. KEYNOTE-826 Study demonstrated survival benefit of adding pembrolizumab into the standard first-line treatment for cervical cancer. Here we designed a exploratory clinical study to test a new treatment combination including cadonilimab and anlotinib in recurrent, metastasis and persistent cervical cancer. All participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (8mg) orally in day 1 to day 14, then take a 7-days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Cadonilimab, Drug: Anlotinib, Drug: Granulocyte-Macrophage Colony-Stimulating FactorThis trial has a single treatment arm. All participants will receive small treatment including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor in this arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Obtain informed consent signed by the patient or their legal representative;
- Female patients aged ≥18 and ≤75 years old;
- ECOG PS score of 0-1;
- Expected survival period ≥6 months;
- Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma originating from the cervix;
Key exclusion criteria (21 listed)
- Any unstable systemic diseases, including but not limited to active infections within 4 weeks (defined as fever exceeding 38.5°C, evidence of bacteremia, or evidence of infectious changes in the heart, brain, kidneys, lungs, liver, and intestines), circulatory accidents within 6 months (malignant hypertensive crisis, myocardial infarction, severe/unstable angina, heart failure above NYHA class 2, clinically significant supraventricular or ventricular arrhythmias, or cerebral vascular accidents not yet recovered from or resulting in severe sequelae), uncontrolled type 2 diabetes (fasting blood glucose >11.1 mmol/L or glycated hemoglobin >8%), and pulmonary insufficiency (any cause leading to decreased lung function, defined as FEV1/FVC <70%, FEV1 <80% of predicted value).
- History of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune liver diseases, systemic vasculitis, scleroderma, dermatomyositis, autoimmune hemolytic anemia;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the assay) or combined hepatitis B and hepatitis C infection;
- History of attenuated live vaccine administration within 28 days before the first dose of the study drug or expected attenuated live vaccine administration during the study period;
- Tumor invasion of major blood vessels on imaging or investigator judgment indicating a high risk of tumor invasion of important vessels causing fatal bleeding or other diseases with a high risk of severe bleeding;
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 |
|---|---|---|
| CadonilimabAlso: AK104All Participants will receive cadonilimab of 10mg/kg every three weeks at day 1 | Drug | Treatment arm |
| AnlotinibAlso: AL001All Participants will take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break. | Drug | Treatment arm |
| Granulocyte-Macrophage Colony-Stimulating FactorAll Participants will have subcutaneously injection of granulocyte-macrophage colony-stimulating factor from day 1 to day 14, then take a 7 days break. | Drug | Treatment arm |
Primary outcome
Objective response rate
Time frame: up to 2 years
Rate of participants with complete response plus partial response as best response in the intent to treatment group according to RECIST 1.1
5 secondary outcomes
Rate and grade of adverse events
Time frame: From enrollment to 90 days after last treatment of all subjects
Disease control rate
Time frame: up to 2 years
Duration of Response
Time frame: Up to 2 years
Progression free survival rate
Time frame: Up to 2 years
Overall survival rate
Time frame: Up to 2 years
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 19 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Hui Qiu, Ph.D. principal investigator
Wuhan University
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 Cadonilimab, Anlotinib and Granulocyte-Macrophage Colony-Stimulating Factor in people with Cervical Cancer, run by Zhongnan 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 15 inclusion and 21 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 19 Apr 2024. 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 Shaoxing Sun, M.D. (+08613871286154, sunshaoxing@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.