Bladder CancerPhase 2NCT06009848
Cadonilimab Plus Nab-Paclitaxel for Recurrent or Metastatic Muscle Invasive Bladder Cancer
A Phase 2 study testing Cadonilimab in people with Bladder Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Cadonilimab(AK104) combined with Nab -Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Cadonilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form before joining the group.
- Age>18 years old.
- Patients with advanced metastatic bladder cancer confirmed histologically or pathologically.
- Have not received systemic treatment.
- Have measurable lesions (according to RECIST 1.1 standard, non lymph node lesions have a CT scan length of ≥ 10 mm, and lymph node lesions have a CT scan short diameter of ≥ 15 mm).
- ECOG PS score: 0-1.
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- The expected survival period is greater than 12 weeks.
- The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days):
- Blood routine: Neutrophils ≥ 1.5 × 10^9/L;Platelet count ≥ 100 × 10^9/L;Hemoglobin ≥ 90g/L.
- Liver and kidney function:Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥ 50 ml/min (Cockcroft Fault formula);Liver function: Aspartate aminotransferase (AST) ≤ 2.5 x ULN, alanine liver aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastasis; ALT and AST<5 x ULN in liver metastasis subjects.;Total serum bilirubin (TBIL) ≤ 1.5 x ULN (excluding Gilbert syndrome where TBIL<3.0 mg/dL);Urinary protein<2+;If the urine protein is ≥ 2+, the 24-hour urine protein quantitative display must be ≤ 1g.
- 9. Normal coagulation function, no active bleeding or thrombosis disease
- International standardized ratio INR ≤ 1.5 × ULN;
- Partial thromboplastin time APTT ≤ 1.5 × ULN;
- Prothrombin time PT ≤ 1.5 × ULN. 10. Non surgical sterilization or reproductive age female patients are required to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period. Non surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before enrollment in the study. And it must be non lactating.
- 11. The subjects voluntarily joined this study with good compliance, safety, and survival follow-up.
Who cannot join
- The subject has previously or simultaneously suffered from other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
- The subject is known to have previous allergies to macromolecular protein formulations or known to be allergic to the drug components used.
- The subject has any active autoimmune disease or a history of autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function, who have undergone thyroid surgery in the past cannot be included. subjects with vitiligo or complete remission of childhood asthma, who do not require any intervention in adulthood, can be included. subjects who require bronchodilators for medical intervention) Asthma cannot be included).
- The subject is currently using immunosuppressive agents or systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones), and continues to use them within 2 weeks before enrollment.
- Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage.
- Patients with clinically uncontrollable cardiac symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention.
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- The subject has an active infection or an unexplained fever>38.5 degrees Celsius during the screening period or before the first administration (according to the researcher's judgment, the subject's fever caused by the tumor can be included in the group).
- Patients with past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function with objective evidence.
- Subjects have congenital or acquired immune deficiency, such as HIV infected persons, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA ≥ 1000 IU/ml. hepatitis C reference: HCV RNA ≥ 1000 IU/ml). Chronic hepatitis B virus carriers with HBV DNA<2000 IU/ml must receive antiviral treatment simultaneously during the trial period before they can be enrolled.
- Live vaccines may be administered less than 4 weeks before the study medication or during the study period.
- The subject is known to have a history of psychotropic substance abuse, alcoholism, or drug abuse.
- Accepted Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 2 weeks before the first administration.
- The researcher believes that it should be excluded from this study. For example, based on the researcher's judgment, the subject may have other factors that may cause the study to be terminated midway, such as other serious diseases (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which may affect the safety of the subject, or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211
Haitao Wang, Ph.D, +86-022-88326385, peterrock2000@126.com
Jinhuan Wang, Ph.D, +86-18202249715, wjhhappy2008@163.com
About this study
Official title: An Open ,Single Arm, Prospective, Phase II Clinical Study on the First-line Treatment of Recurrent or Metastatic Muscle Invasive Bladder Cancer With Cadonilimab(AK104) Plus Nab-Paclitaxel
The goal of this clinical trial is to evaluate the efficacy and safety of Cadonilimab(AK104) combined with Nab -Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder. Eligible participants will receive AK104 (up to 24 months) plus Nab-Paclitaxel (for 6 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.
Read the detailed description
Cadonilimab(AK104) is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical phase II trial is to evaluate the efficacy and safety of AK104 combined with Nab-Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder.
- Conditions
- Bladder Cancer
- Being tested
- Cadonilimab
- Keywords
- Muscle Invasive Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Also called AK104
Cadonilimab (10 mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+Nab-Paclitaxel(200 mg/m2, Q3W ,6 cycles), every 3 weeks (21 days) is a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab (AK104) combined with Nab -Paclitaxel | Experimental | Cadonilimab (10 mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+Nab-Paclitaxel(200 mg/m2, Q3W, 6cycles), every 3 weeks (21 days) is a treatment cycle Receives: Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST v1.1.
Measured: The last subject completes at least 24 weeks of follow-up (or disease progression)
Secondary outcomes (4)
Overall Survival(OS)
The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST v1.1.
Measured: 24 months
Progression-free Survival(PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST v1.1.
Measured: The last subject completes at least 24 weeks of follow-up (or disease progression)
Duration of Response(DOR)
Duration of response (DOR) as assessed by the investigator according to RECIST v1.1.
Measured: The last subject completes at least 24 weeks of follow-up (or disease progression)
Adverse events(AEs）
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events,AEs evaluated according to NCI-CTCAE v5.0 and irAE.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start10 Oct 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009848
- Sponsor's protocol ID
- AK104-MIBC
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open ,Single Arm, Prospective, Phase II Clinical Study on the First-line Treatment of Recurrent or Metastatic Muscle Invasive Bladder Cancer With Cadonilimab(AK104) Plus Nab-Paclitaxel
- ClinicalTrials.gov ID
- NCT06009848
- Acronym / sponsor ID
- AK104-MIBC
- Conditions
- Bladder Cancer
- Keywords
- Muscle Invasive Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Aug 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 evaluate the efficacy and safety of Cadonilimab(AK104) combined with Nab -Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder. Eligible participants will receive AK104 (up to 24 months) plus Nab-Paclitaxel (for 6 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.
Detailed description
Cadonilimab(AK104) is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical phase II trial is to evaluate the efficacy and safety of AK104 combined with Nab-Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab (AK104) combined with Nab -Paclitaxel | Experimental | Drug: CadonilimabCadonilimab (10 mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+Nab-Paclitaxel(200 mg/m2, Q3W, 6cycles), every 3 weeks (21 days) is a treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sign a written informed consent form before joining the group.
- Age>18 years old.
- Patients with advanced metastatic bladder cancer confirmed histologically or pathologically.
- Have not received systemic treatment.
- Have measurable lesions (according to RECIST 1.1 standard, non lymph node lesions have a CT scan length of ≥ 10 mm, and lymph node lesions have a CT scan short diameter of ≥ 15 mm).
Key exclusion criteria (13 listed)
- The subject has previously or simultaneously suffered from other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
- The subject is known to have previous allergies to macromolecular protein formulations or known to be allergic to the drug components used.
- The subject has any active autoimmune disease or a history of autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function, who have undergone thyroid surgery in the past cannot be included. subjects with vitiligo or complete remission of childhood asthma, who do not require any intervention in adulthood, can be included. subjects who require bronchodilators for medical intervention) Asthma cannot be included).
- The subject is currently using immunosuppressive agents or systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones), and continues to use them within 2 weeks before enrollment.
- Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage.
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: AK104Cadonilimab (10 mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+Nab-Paclitaxel(200 mg/m2, Q3W ,6 cycles), every 3 weeks (21 days) is a treatment cycle. | Drug | Cadonilimab (AK104) combined with Nab -Paclitaxel |
Primary outcome
Objective Response Rate(ORR)
Time frame: The last subject completes at least 24 weeks of follow-up (or disease progression)
The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST v1.1.
4 secondary outcomes
Overall Survival(OS)
Time frame: 24 months
Progression-free Survival(PFS)
Time frame: The last subject completes at least 24 weeks of follow-up (or disease progression)
Duration of Response(DOR)
Time frame: The last subject completes at least 24 weeks of follow-up (or disease progression)
Adverse events(AEs）
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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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.
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 in people with Bladder Cancer, run by Tianjin Medical University Second 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 13 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 24 Aug 2023. 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 HaiTao Wang, Ph.D (+86-022-88326385, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: The last subject completes at least 24 weeks of follow-up (or disease progression)). 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 24 Aug 2023.