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A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

Primary Purpose

Muscle Invasive Bladder Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RC48-ADC
AK104
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Invasive Bladder Carcinoma focused on measuring RC48-ADC, AK104

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RC48-ADC +AK104

Arm Description

Participants received 4 preoperative cycles of RC48-ADC(2.0 mg/kg,Q2W) plus AK104(6.0 mg/kg,Q2W), followed by surgery, followed by up to 14 cycles of postoperative AK104(10 mg/kg,Q3W)and 6 cycles of postoperative RC48-ADC(2 mg/kg,Q3W)

Outcomes

Primary Outcome Measures

Pathologic Complete Response (pCR) Rate
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 Outcome Measures

Rate of Pathologic Response
No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen.
1-3 year Disease Free Survival Rate
The percentage of participants disease free on 1-3 year after surgery.
Objective Response Rate (ORR)
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Overall Survival (OS)
Overall survival is defined as the time from enrollment to death due to any cause.

Full Information

First Posted
August 22, 2023
Last Updated
October 6, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Shanxi Province Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06074484
Brief Title
A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
Official Title
An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With AK104 in Perioperative Treatment of Muscle-Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2023 (Actual)
Primary Completion Date
August 10, 2024 (Anticipated)
Study Completion Date
August 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Shanxi Province Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Invasive Bladder Carcinoma
Keywords
RC48-ADC, AK104

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RC48-ADC +AK104
Arm Type
Experimental
Arm Description
Participants received 4 preoperative cycles of RC48-ADC(2.0 mg/kg,Q2W) plus AK104(6.0 mg/kg,Q2W), followed by surgery, followed by up to 14 cycles of postoperative AK104(10 mg/kg,Q3W)and 6 cycles of postoperative RC48-ADC(2 mg/kg,Q3W)
Intervention Type
Drug
Intervention Name(s)
RC48-ADC
Other Intervention Name(s)
Disitamab Vedotin
Intervention 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)
Intervention Type
Drug
Intervention Name(s)
AK104
Other Intervention Name(s)
Cadonilimab Injection
Intervention 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)
Primary Outcome Measure Information:
Title
Pathologic Complete Response (pCR) Rate
Description
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.
Time Frame
Up to approximately 16 Weeks (Time of surgery)
Secondary Outcome Measure Information:
Title
Rate of Pathologic Response
Description
No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen.
Time Frame
Up to approximately 16 Weeks (Time of surgery)
Title
1-3 year Disease Free Survival Rate
Description
The percentage of participants disease free on 1-3 year after surgery.
Time Frame
From approximately 12 Months up to approximately 36 Months
Title
Objective Response Rate (ORR)
Description
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time Frame
Up to approximately 16 Weeks
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from enrollment to death due to any cause.
Time Frame
Up to approximately 60 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xin wang, Doctor
Phone
87787170
Ext
010
Email
WXCAMS@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nianzeng Xing, Doctor
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xin wang
Phone
010-87787170

12. IPD Sharing Statement

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A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

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