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Trial Title:
A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
NCT ID:
NCT06074484
Condition:
Muscle Invasive Bladder Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Disitamab vedotin
Conditions: Keywords:
RC48-ADC
AK104
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:
RC48-ADC
Description:
4 preoperative cycles of RC48-ADC （2.0 mg/kg，intravenous (IV) infusion，Q2W）, followed by
surgery, followed by up to 6 cycles of postoperative RC48-ADC（2.0 mg/kg，intravenous (IV)
infusion，Q3W）
Arm group label:
RC48-ADC +AK104
Other name:
Disitamab Vedotin
Intervention type:
Drug
Intervention name:
AK104
Description:
4 preoperative cycles of AK104（6.0 mg/kg，intravenous (IV) infusion，Q2W）, followed by
surgery, followed by up to 14 cycles of postoperative AK104（10 mg/kg，intravenous (IV)
infusion，Q3W）
Arm group label:
RC48-ADC +AK104
Other name:
Cadonilimab Injection
Summary:
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with
AK104 in perioperative treatment of muscle-invasive bladder cancer.
Detailed description:
36 patients with Muscle-invasive Bladder Cancer（MIBC） scheduled for radical cystectomy
will participate in this study. The patient had not previously received any antitumor
system therapy for MIBC. HER2 expression in MIBC patients is defined as the expression of
HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. After
enrollment, the subjects will receive 4 cycles neoadjuvant therapy and 14 cycles adjuvant
therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- Male or female, Age ≥ 18 years.
- Predicted survival ≥ 12 weeks.
- Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC) .Naive
of antitumor systematic treatment or radiotherapy.
- Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by
imaging. Voluntary agreement to provide written informed consent.
- Male or female, Age ≥ 18 years.
- Predicted survival ≥ 12 weeks.
- Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC).Naive of
antitumor systematic treatment or radiotherapy.
- Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by
imaging.
- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection
(PLND).
- HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function, evidenced by the following laboratory results within 7 days
prior to the study treatment.
- Male and female participants are eligible to participate if they agree to the
contraception use as per study protocol.
- Willing to adhere to the study visit schedule and the prohibitions and restrictions
specified in this protocol.
- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection
(PLND).
- HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function, evidenced by the following laboratory results within 7 days
prior to the study treatment.
- Male and female participants are eligible to participate if they agree to the
contraception use as per study protocol.
- Willing to adhere to the study visit schedule and the prohibitions and restrictions
specified in this protocol.
Exclusion Criteria:
- Has received other antitumor therapy before planned start of trial treatment.
- History of major surgery within 4 weeks of planned start of trial treatment.
- Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive,
or HIVAb positive.
- Has received a live virus vaccine within 4 weeks of planned start of trial
treatment.
- NYHA Class III heart failure.
- Suffering from active infection requiring systemic treatment.
- Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
- Treated with systemic treatment (e.g. immunomodulators, corticosteroids or
immunosuppressants) for the autoimmune disease within 2 years prior to the study
treatment.
- History of other malignancy within the previous 5 years, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers
with a similar curative outcome as those mentioned above.
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator.
- Pregnancy or lactation.
- Assessed by the investigator to be unable or unwilling to comply with the
requirements of the protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
xin wang
Phone:
010-87787170
Start date:
September 10, 2023
Completion date:
August 10, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06074484
