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Oncolytic Adenovirus Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer

Primary Purpose

Bladder Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

H101, Camrelizumab

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder cancer, oncolytic adenovirus, intravesical therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18 ~80 years old.
Patients who are diagnosed pathologically with urothelial carcinoma of non-muscle invasive bladder cancer and have previously failed BCG therapy and refused cystectomy.
Performance status: Eastern Cooperative Oncology Group performance 0-2.
Life expectancy more than 3 months.
Patients have adequate organ function, accord with following criteria: A. blood routine: Hemoglobin≥90g/L, absolute neutrophil count≥1.5×10*9/L, platelet count ≥ 80×109/L; B. Biochemical tests: total bilirubin is less than 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times upper limit of normal; C. creatinine less than 1.25 times upper limit of normal.
Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women.
Participant sign an institutional review board-approved, protocol specific informed consent form in accordance with institutional guidelines.

Exclusion Criteria:

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
Organs failure.
ECOG >2.
Serious/active infection.
Autoimmune disorders or immunodeficiency diseases.
Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids.
Uncontrolled hypertension.
Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia.
Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <50%.
Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy.
Unhealed wounds, or fractures.
With a history of psychotropic drug abuse or mental disorders.
Prior systemic therapies with any antitumor agents within 4 weeks.
With other uncurable cancers simultaneously.

Sites / Locations

Hua WangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination of H101 with Camrelizumab treatment

Arm Description

Patients receive a combination therapy of PD-1 inhibitor Camrelizumab with oncolytic adenovirus H101 for up to 1 years. Camrelizumab are administered at dose of 200 mg i.v. every 3 weeks. H101 are instilled intravesically with a dose of 5×10*11 Vp in a 50 mL normal saline solution via a catheter, and dwell time is 1 to 2 hours,. Intravesical H101 is instilled weekly for 6 weeks for both induction and maintenance treatments.

Outcomes

Primary Outcome Measures

complete response (CR)

CR is deemed by negative cystoscopy, urine cytology, and bladder biopsies.

Secondary Outcome Measures

Full Information

NCT ID

NCT05564897

First Posted

September 29, 2022

Last Updated

October 2, 2022

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05564897

Brief Title

Oncolytic Adenovirus Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer

Official Title

Phase II Single Center Open-Label Single-Arm Study of the Safety and Efficacy of Oncolytic Adenovirus H101 Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer Who Failed BCG Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 26, 2022 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

H101 is an E1B55KD deleted oncolytic adenovirus, which is the first and only adenovirus to be approved by China State Food and Drug Administration in 2005 for treating head and neck cancer. The objective of this phase II clinical trial is to investigate the safety and efficacy of H101 combined with PD-1 inhibitor Camrelizumab in patients with non-muscle-invasive bladder cancer who failed BCG therapy.

Detailed Description

CHUCAS-030 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at Cancer Hospital, University of Chinese Academy of Sciences in the Zhejiang Province, China. Eligible patients are 18 to 80 years old with non-muscle-invasive bladder cancer who has previously failed BCG therapy and refuse cystectomy. Patients receive a combination therapy of PD-1 inhibitor Camrelizumab with oncolytic adenovirus H101 for up to 1 year. Camrelizumab are administered at dose of 200 mg i.v. every 3 weeks. H101 are instilled intravesically after 14 days from the most recent biopsy and in the absence of any evidence of hematuria with a fixed dose of 5×10*11 Vp in a 50 mL normal saline solution via a catheter, and dwell time is 1 to 2 hours, and patients are encouraged to reposition to maximize bladder surface exposure. Intravesical H101 is instilled weekly for 6 weeks for both induction and maintenance treatments. Patients who experienced unacceptable toxicities or clinical or documented progressive disease are discontinued from the study. The duration of any objective response is measured from the date the initial response is observed to the date that disease progression is observed. Response assessment with cystoscopy, bladder biopsy of visually positive lesions and urine cytology are first evaluated after induction at 3 months. Patients with complete response (CR) at 3 months receive no intervention and are reevaluated at 6 months. Patients with stable disease (SD) receive maintenance treatment at 3 to 4 months. Patients with progressive disease (PD) are deemed non-responders and strongly counseled to reconsider cystectomy or alternative treatment. Patients with CR at 6 months receive maintenance treatment (weekly treatments for 6 weeks). All patients were followed up until death from any cause.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Bladder cancer, oncolytic adenovirus, intravesical therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination of H101 with Camrelizumab treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

H101, Camrelizumab

Intervention Description

Patients receive a combination therapy of Camrelizumab 200 mg i.v. every 3 weeks with intravesical H101 with a dose of 5×10*11 Vp weekly for 6 weeks for both induction and maintenance treatments up to 1 years.

Primary Outcome Measure Information:

Title

complete response (CR)

Description

CR is deemed by negative cystoscopy, urine cytology, and bladder biopsies.

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18 ~80 years old. Patients who are diagnosed pathologically with urothelial carcinoma of non-muscle invasive bladder cancer and have previously failed BCG therapy and refused cystectomy. Performance status: Eastern Cooperative Oncology Group performance 0-2. Life expectancy more than 3 months. Patients have adequate organ function, accord with following criteria: A. blood routine: Hemoglobin≥90g/L, absolute neutrophil count≥1.5×10*9/L, platelet count ≥ 80×109/L; B. Biochemical tests: total bilirubin is less than 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times upper limit of normal; C. creatinine less than 1.25 times upper limit of normal. Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women. Participant sign an institutional review board-approved, protocol specific informed consent form in accordance with institutional guidelines. Exclusion Criteria: Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Organs failure. ECOG >2. Serious/active infection. Autoimmune disorders or immunodeficiency diseases. Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids. Uncontrolled hypertension. Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia. Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <50%. Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy. Unhealed wounds, or fractures. With a history of psychotropic drug abuse or mental disorders. Prior systemic therapies with any antitumor agents within 4 weeks. With other uncurable cancers simultaneously.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hua Wang, Ph.D.；M.D.

Phone

+86-571-8812-8031

wanghua@zjcc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yedie He, M.D.

Phone

+86-571-8812-8031

525507831@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hua Wang, Ph.D.；M.D.

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Hua Wang

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hua Wang, Ph.D.; M.D.

Phone

+86-571-8812-8031

wanghua@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Oncolytic Adenovirus Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer

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