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

NCT06074484 | Unknown Phase 2

• 1 other identifier: RCVDUCIIR012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Invasive Bladder Carcinoma

Keywords

RC48-ADC; AK104

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 16 Weeks (Time of surgery)

Secondary Outcomes (4)

• Rate of Pathologic Response

  Up to approximately 16 Weeks (Time of surgery)

• 1-3 year Disease Free Survival Rate

  From approximately 12 Months up to approximately 36 Months

• Objective Response Rate (ORR)

  Up to approximately 16 Weeks

• Overall Survival (OS)

  Up to approximately 60 Months

Study Arms (1)

RC48-ADC +AK104

EXPERIMENTAL

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）

Drug: RC48-ADC; Drug: AK104

Interventions

RC48-ADC DRUG

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）

Also known as: Disitamab Vedotin

RC48-ADC +AK104

AK104 DRUG

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）

Also known as: Cadonilimab Injection

RC48-ADC +AK104

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Shanxi Province Cancer Hospital: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Interventions

disitamab vedotin

Study Officials

• Nianzeng Xing, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xin wang, Doctor

CONTACT

87787170; WXCAMS@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: October 10, 2023
• Study Start: September 10, 2023
• Primary Completion: August 10, 2024
• Study Completion: August 10, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-08

Locations

CN (1)