Muscle Invasive Bladder Carcinoma
Conditions
Brief summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in perioperative treatment of muscle-invasive bladder cancer.
Interventions
DRUGRC48-ADC
Drug: RC48-ADC 2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
DRUGJS001
Drug: JS001 3.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response (pCR) Rate | Up to approximately 16 Weeks (Time of surgery) | pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue from RC and PLND. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Pathologic Response | Up to approximately 16 Weeks (Time of surgery) | No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen. |
| 1-year Disease Free Survival Rate | From approximately 16 Weeks up to approximately 12 Months. | The percentage of participants disease free on 1 year after surgery. |
| Objective Response Rate (ORR) | Up to approximately 12 Weeks. | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) |
| Overall Survival (OS) | Up to approximately 60 Months. | Overall survival is defined as the time from enrollment to death due to any cause. |
Countries
China
Contacts
Primary ContactJianmin Fang
Backup ContactNa Su
Outcome results
None listed