Trial Title:
Cadonilimab Plus Nab-Paclitaxel for Recurrent or Metastatic Muscle Invasive Bladder Cancer
NCT ID:
NCT06009848
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Muscle Invasive Bladder Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
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.
Arm group label:
Cadonilimab (AK104) combined with Nab -Paclitaxel
Other name:
AK104
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign a written informed consent form before joining the group.
2. Age>18 years old.
3. Patients with advanced metastatic bladder cancer confirmed histologically or
pathologically.
4. Have not received systemic treatment.
5. 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).
6. ECOG PS score: 0-1.
7. The expected survival period is greater than 12 weeks.
8. The functions of important organs meet the following requirements (excluding the use
of any blood components and cell growth factors within 14 days):
(1) Blood routine: Neutrophils ≥ 1.5 × 10^9/L;Platelet count ≥ 100 × 10^9/L;Hemoglobin ≥
90g/L.
(2) 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
1. International standardized ratio INR ≤ 1.5 × ULN;
2. Partial thromboplastin time APTT ≤ 1.5 × ULN;
3. 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.
Exclusion Criteria:
1. The subject has previously or simultaneously suffered from other malignant tumors
(excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
2. The subject is known to have previous allergies to macromolecular protein
formulations or known to be allergic to the drug components used.
3. 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).
4. 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.
5. Ascites or pleural effusion with clinical symptoms require therapeutic puncture or
drainage.
6. 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.
7. 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).
8. 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.
9. 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.
10. Live vaccines may be administered less than 4 weeks before the study medication or
during the study period.
11. The subject is known to have a history of psychotropic substance abuse, alcoholism,
or drug abuse.
12. Accepted Chinese herbal medicine or traditional Chinese patent medicines and simple
preparations with anti-tumor indications within 2 weeks before the first
administration.
13. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Second Hospital
Address:
City:
Tianjin
Zip:
300211
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Wang, Ph.D
Phone:
+86-022-88326385
Email:
peterrock2000@126.com
Contact backup:
Last name:
Jinhuan Wang, Ph.D
Phone:
+86-18202249715
Email:
wjhhappy2008@163.com
Investigator:
Last name:
Haitao Wang
Email:
Principal Investigator
Investigator:
Last name:
Jinhuan Wang
Email:
Sub-Investigator
Investigator:
Last name:
Lili Wang
Email:
Sub-Investigator
Investigator:
Last name:
Dingkun Hou
Email:
Sub-Investigator
Start date:
October 10, 2022
Completion date:
October 2025
Lead sponsor:
Agency:
Tianjin Medical University Second Hospital
Agency class:
Other
Source:
Tianjin Medical University Second Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06009848
