Safety and Efficacy of Camrelizumab for High-risk NMIBC Failing BCG Treatment
NCT ID: NCT04706598
Last Updated: 2024-07-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-06-09
Study Completion Date
2024-12-31
Brief Summary
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This study will evaluate the safety and efficacy of bladder intravesical Camrelizumab in patients with high-risk non-muscle-invasive bladder cancer who failed BCG therapy.
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Detailed Description
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Conditions
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Urinary Bladder Neoplasms
Immunotherapy
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Intravesical therapy group
Camrelizumab(SHR-1210) is administered on the first day of each treatment cycle (D1) at a dose up to 200 mg. The recommended phase II dose(RP2D) to be decided after safety run-in.
The cycle is divided into an induction course and a maintenance course. The induction course is initiated 2 weeks after TURBT and repeat once a week for 6 weeks . After that, the maintenance course starts every 3 weeks. The maximum duration of dosing is 2 years.
Group Type
EXPERIMENTAL
Camrelizumab
Intervention Type
DRUG
Solution for Infusion (Intravesical)
Interventions
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Camrelizumab
Solution for Infusion (Intravesical)
Intervention Type
DRUG
Other Intervention Names
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SHR-1210
Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 18 years.
2. Histologically-confirmed diagnosis of high risk non-muscle-invasive urothelial cell carcinoma of the bladder (mixed histology tumors allowed if urothelial carcinoma histology is \>50%).
3. Fully resected disease at study entry (residual CIS acceptable).
4. BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy(at least five times a week during the induction phase and at least two times a week during the maintenance phase).
5. Ineligible for radical cystectomy or refusal of radical cystectomy.
6. Consent to tissue specimen retrieval and testing.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Adequate normal organ and marrow function as defined below:
1. Haemoglobin (HB) ≥ 90 g/L
2. Absolute neutrophil count (ANC) ≥1.5×10\^9/L(no granulocyte colony-stimulating factor support for 2 weeks before day 1 of cycle 1)
3. Lymphocyte count≥0.500×10\^9/L
4. Platelet count ≥100×10\^9/L(No blood transfusions within 2 weeks before day 1 of cycle 1)
5. 4.0×10\^9/L≤White Blood Cell Count (WBC)≤15×10\^9/L
6. AST (SGOT)/ALT (SGPT)/Alkaline phosphatase ≤ 2.5 x institutional upper limit of normal(ULN) (excluded Gilbert's disease patients, whose serum bilirubin level ≤ 3x ULN)
7. INR/aPTT≤1.5×ULN(Which only applies to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be given a stable dose)
8. Serum creatinine (Cr) ≤ 1.5 times the upper institutional limit of normal (ULN) or Serum creatinine Cl\>60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
9. Women of childbearing potential who have a negative serum pregnancy test within 72 hours prior to the first dose should consent to and must use effective contraception during and for 6 months after the end of the study.
10. Men should consent to patients who must use contraception during the study and for 6 months after the end of the study period.
11. The subject is personally willing and able to provide written informed consent to be able to comply with the protocol.
2. Histologically-confirmed diagnosis of high risk non-muscle-invasive urothelial cell carcinoma of the bladder (mixed histology tumors allowed if urothelial carcinoma histology is \>50%).
3. Fully resected disease at study entry (residual CIS acceptable).
4. BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy(at least five times a week during the induction phase and at least two times a week during the maintenance phase).
5. Ineligible for radical cystectomy or refusal of radical cystectomy.
6. Consent to tissue specimen retrieval and testing.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Adequate normal organ and marrow function as defined below:
1. Haemoglobin (HB) ≥ 90 g/L
2. Absolute neutrophil count (ANC) ≥1.5×10\^9/L(no granulocyte colony-stimulating factor support for 2 weeks before day 1 of cycle 1)
3. Lymphocyte count≥0.500×10\^9/L
4. Platelet count ≥100×10\^9/L(No blood transfusions within 2 weeks before day 1 of cycle 1)
5. 4.0×10\^9/L≤White Blood Cell Count (WBC)≤15×10\^9/L
6. AST (SGOT)/ALT (SGPT)/Alkaline phosphatase ≤ 2.5 x institutional upper limit of normal(ULN) (excluded Gilbert's disease patients, whose serum bilirubin level ≤ 3x ULN)
7. INR/aPTT≤1.5×ULN(Which only applies to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be given a stable dose)
8. Serum creatinine (Cr) ≤ 1.5 times the upper institutional limit of normal (ULN) or Serum creatinine Cl\>60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
9. Women of childbearing potential who have a negative serum pregnancy test within 72 hours prior to the first dose should consent to and must use effective contraception during and for 6 months after the end of the study.
10. Men should consent to patients who must use contraception during the study and for 6 months after the end of the study period.
11. The subject is personally willing and able to provide written informed consent to be able to comply with the protocol.
Exclusion Criteria
1. Muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma.
2. Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis)urothelial cell carcinoma.
3. Have participated in a clinical trial of an investigational drug or device within 4 weeks prior to receiving the first treatment in this project.
4. Received chemotherapy, targeted small molecule therapy, immunotherapy or radiation therapy following a recent cystoscopy or transurethral resection of a bladder tumour.
5. History of other malignancies within the last 5 years.
6. Active autoimmune disease that has required systemic treatment in the past 2 years.
7. History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonia, histoplasmosis (i.e. occlusive bronchiolitis, cryptogenic histoplasmosis), or evidence of active pneumonia on chest CT scan (history of fibrosis in radiation pneumonia), patients with active tuberculosis.
8. Active infection requiring systemic therapy,therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrolment (patients receiving prophylactic antibiotics (e.g. for the prevention of urinary tract infections or chronic obstructive pulmonary disease) can be enrolled).
9. Patients who are pregnant or breastfeeding, or expecting to conceive .
10. Previous treatment with anti-PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA-4 monoclonal antibody, or other drugs that act on T-cell co-stimulation or any other antibody of the checkpoint pathway.
11. Patients with known positive test for human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
12. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (Hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV viral copy number \> upper limit of normal value).
13. Received a live virus vaccine within 30 days of planned start of study treatment.
14. Has had an allogeneic tissue/solid organ transplant.
15. Long-term oral steroids, more than 10 mg/day of methandrostenolone or similar, must be stopped for 28 days before entry into the group.
16. Evidence of apparently uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of the results, including significant liver disease (e.g. cirrhosis, uncontrolled major seizures or superior vena cava syndrome).
17. Significant cardiovascular disease, such as New York Heart Association heart attack (class II or higher), myocardial infarction, unstable arrhythmia or unstable angina within 3 months prior to study entry.
18. Patients who have had major surgery within 4 weeks prior to study entry, or who are expected to require major surgery during the course of the study, except diagnostic procedures such as TURBT or biopsy.
19. History of autoimmune diseases, including but not limited to severe muscle weakness, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, angio-thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, dry syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
20. History of severe allergy, sensitisation or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins.
21. Patients who, in the opinion of the investigator, are otherwise unable to participate in this trial.
2. Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis)urothelial cell carcinoma.
3. Have participated in a clinical trial of an investigational drug or device within 4 weeks prior to receiving the first treatment in this project.
4. Received chemotherapy, targeted small molecule therapy, immunotherapy or radiation therapy following a recent cystoscopy or transurethral resection of a bladder tumour.
5. History of other malignancies within the last 5 years.
6. Active autoimmune disease that has required systemic treatment in the past 2 years.
7. History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonia, histoplasmosis (i.e. occlusive bronchiolitis, cryptogenic histoplasmosis), or evidence of active pneumonia on chest CT scan (history of fibrosis in radiation pneumonia), patients with active tuberculosis.
8. Active infection requiring systemic therapy,therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrolment (patients receiving prophylactic antibiotics (e.g. for the prevention of urinary tract infections or chronic obstructive pulmonary disease) can be enrolled).
9. Patients who are pregnant or breastfeeding, or expecting to conceive .
10. Previous treatment with anti-PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA-4 monoclonal antibody, or other drugs that act on T-cell co-stimulation or any other antibody of the checkpoint pathway.
11. Patients with known positive test for human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
12. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (Hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV viral copy number \> upper limit of normal value).
13. Received a live virus vaccine within 30 days of planned start of study treatment.
14. Has had an allogeneic tissue/solid organ transplant.
15. Long-term oral steroids, more than 10 mg/day of methandrostenolone or similar, must be stopped for 28 days before entry into the group.
16. Evidence of apparently uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of the results, including significant liver disease (e.g. cirrhosis, uncontrolled major seizures or superior vena cava syndrome).
17. Significant cardiovascular disease, such as New York Heart Association heart attack (class II or higher), myocardial infarction, unstable arrhythmia or unstable angina within 3 months prior to study entry.
18. Patients who have had major surgery within 4 weeks prior to study entry, or who are expected to require major surgery during the course of the study, except diagnostic procedures such as TURBT or biopsy.
19. History of autoimmune diseases, including but not limited to severe muscle weakness, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, angio-thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, dry syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
20. History of severe allergy, sensitisation or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins.
21. Patients who, in the opinion of the investigator, are otherwise unable to participate in this trial.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Shanghai Shen Kang Hospital Development Center
OTHER
Sponsor Role
collaborator
Fudan University
OTHER
Sponsor Role
lead
Responsible Party
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Ding-Wei Ye
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Xiang Wang, MD
Role: STUDY_DIRECTOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Yushan Liu, MD
Role: STUDY_DIRECTOR
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Xudong Yao, MD
Role: STUDY_DIRECTOR
Shanghai Tenth People's Hospital,Shanghai Tong Ji University School of Medicine
Locations
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Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Site Status
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Site Status
Shanghai Tenth People's Hospital,Shanghai Tong Ji University School of Medicine
Shanghai, Shanghai Municipality, China
Site Status
Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Site Status
Countries
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China
References
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Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer: a meta-analysis of published results of randomized clinical trials. J Urol. 2004 Jun;171(6 Pt 1):2186-90, quiz 2435. doi: 10.1097/01.ju.0000125486.92260.b2.
Reference Type
RESULT
Taniguchi K, Koga S, Nishikido M, Yamashita S, Sakuragi T, Kanetake H, Saito Y. Systemic immune response after intravesical instillation of bacille Calmette-Guerin (BCG) for superficial bladder cancer. Clin Exp Immunol. 1999 Jan;115(1):131-5. doi: 10.1046/j.1365-2249.1999.00756.x.
Reference Type
RESULT
Mitropoulos DN. Novel insights into the mechanism of action of intravesical immunomodulators. In Vivo. 2005 May-Jun;19(3):611-21.
Reference Type
RESULT
Kamat AM, Flaig TW, Grossman HB, Konety B, Lamm D, O'Donnell MA, Uchio E, Efstathiou JA, Taylor JA 3rd. Expert consensus document: Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer. Nat Rev Urol. 2015 Apr;12(4):225-35. doi: 10.1038/nrurol.2015.58. Epub 2015 Mar 24.
Reference Type
RESULT
Witjes JA, Palou J, Soloway M, Lamm D, Kamat AM, Brausi M, Persad R, Buckley R, Colombel M, Bohle A. Current clinical practice gaps in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) with emphasis on the use of bacillus Calmette-Guerin (BCG): results of an international individual patient data survey (IPDS). BJU Int. 2013 Oct;112(6):742-50. doi: 10.1111/bju.12012. Epub 2013 Mar 1.
Reference Type
RESULT
Oddens JR, Sylvester RJ, Brausi MA, Kirkels WJ, van de Beek C, van Andel G, de Reijke TM, Prescott S, Witjes JA, Oosterlinck W. The effect of age on the efficacy of maintenance bacillus Calmette-Guerin relative to maintenance epirubicin in patients with stage Ta T1 urothelial bladder cancer: results from EORTC genito-urinary group study 30911. Eur Urol. 2014 Oct;66(4):694-701. doi: 10.1016/j.eururo.2014.05.033. Epub 2014 Jun 16.
Reference Type
RESULT
Chang SS, Bochner BH, Chou R, Dreicer R, Kamat AM, Lerner SP, Lotan Y, Meeks JJ, Michalski JM, Morgan TM, Quale DZ, Rosenberg JE, Zietman AL, Holzbeierlein JM. Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer: American Urological Association/American Society of Clinical Oncology/American Society for Radiation Oncology/Society of Urologic Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2017 Sep;13(9):621-625. doi: 10.1200/JOP.2017.024919. Epub 2017 Aug 10. No abstract available.
Reference Type
RESULT
Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
Reference Type
RESULT
Dinney CP, Greenberg RE, Steinberg GD. Intravesical valrubicin in patients with bladder carcinoma in situ and contraindication to or failure after bacillus Calmette-Guerin. Urol Oncol. 2013 Nov;31(8):1635-42. doi: 10.1016/j.urolonc.2012.04.010. Epub 2012 May 9.
Reference Type
RESULT
Couzin-Frankel J. Breakthrough of the year 2013. Cancer immunotherapy. Science. 2013 Dec 20;342(6165):1432-3. doi: 10.1126/science.342.6165.1432. No abstract available.
Reference Type
RESULT
Inamura K. Bladder Cancer: New Insights into Its Molecular Pathology. Cancers (Basel). 2018 Apr 1;10(4):100. doi: 10.3390/cancers10040100.
Reference Type
RESULT
Catalona WJ, Hudson MA, Gillen DP, Andriole GL, Ratliff TL. Risks and benefits of repeated courses of intravesical bacillus Calmette-Guerin therapy for superficial bladder cancer. J Urol. 1987 Feb;137(2):220-4. doi: 10.1016/s0022-5347(17)43959-0.
Reference Type
RESULT
Pietzak EJ, Bagrodia A, Cha EK, Drill EN, Iyer G, Isharwal S, Ostrovnaya I, Baez P, Li Q, Berger MF, Zehir A, Schultz N, Rosenberg JE, Bajorin DF, Dalbagni G, Al-Ahmadie H, Solit DB, Bochner BH. Next-generation Sequencing of Nonmuscle Invasive Bladder Cancer Reveals Potential Biomarkers and Rational Therapeutic Targets. Eur Urol. 2017 Dec;72(6):952-959. doi: 10.1016/j.eururo.2017.05.032. Epub 2017 Jun 3.
Reference Type
RESULT
Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971.
Reference Type
RESULT
Zhu J, Armstrong AJ, Friedlander TW, Kim W, Pal SK, George DJ, Zhang T. Biomarkers of immunotherapy in urothelial and renal cell carcinoma: PD-L1, tumor mutational burden, and beyond. J Immunother Cancer. 2018 Jan 25;6(1):4. doi: 10.1186/s40425-018-0314-1.
Reference Type
RESULT
Inman BA, Sebo TJ, Frigola X, Dong H, Bergstralh EJ, Frank I, Fradet Y, Lacombe L, Kwon ED. PD-L1 (B7-H1) expression by urothelial carcinoma of the bladder and BCG-induced granulomata: associations with localized stage progression. Cancer. 2007 Apr 15;109(8):1499-505. doi: 10.1002/cncr.22588.
Reference Type
RESULT
He YT, Li DJ, Liang D, Zheng RS, Zhang SW, Zeng HM, Chen WQ, He J. [Incidence and mortality of bladder cancer in China, 2014]. Zhonghua Zhong Liu Za Zhi. 2018 Sep 23;40(9):647-652. doi: 10.3760/cma.j.issn.0253-3766.2018.09.002. Chinese.
Reference Type
RESULT
Other Identifiers
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MA-UC-II-004
Identifier Type: -
Identifier Source: org_study_id
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