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Urinary Bladder NeoplasmsPhase 1/2NCT04706598

Safety and Efficacy of Camrelizumab for High-risk NMIBC Failing BCG Treatment

A Phase 1/2 study testing Camrelizumab in people with Urinary Bladder Neoplasms and Immunotherapy, run by Fudan University at 4 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms, Immunotherapy
What is being tested?
Camrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesChina
Study dates
9 Jun 2021to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • 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%).
  • Fully resected disease at study entry (residual CIS acceptable).
  • 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).
  • Ineligible for radical cystectomy or refusal of radical cystectomy.
  • Consent to tissue specimen retrieval and testing.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate normal organ and marrow function as defined below:
  • Haemoglobin (HB) ≥ 90 g/L
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L(no granulocyte colony-stimulating factor support for 2 weeks before day 1 of cycle 1)
  • Lymphocyte count≥0.500×10^9/L
  • Platelet count ≥100×10^9/L(No blood transfusions within 2 weeks before day 1 of cycle 1)
  • 4.0×10^9/L≤White Blood Cell Count (WBC)≤15×10^9/L
  • 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)
  • INR/aPTT≤1.5×ULN(Which only applies to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be given a stable dose)
  • 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)
  • 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.
  • Men should consent to patients who must use contraception during the study and for 6 months after the end of the study period.
  • The subject is personally willing and able to provide written informed consent to be able to comply with the protocol.

Who cannot join

  • Muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma.
  • Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis)urothelial cell carcinoma.
  • Have participated in a clinical trial of an investigational drug or device within 4 weeks prior to receiving the first treatment in this project.
  • Received chemotherapy, targeted small molecule therapy, immunotherapy or radiation therapy following a recent cystoscopy or transurethral resection of a bladder tumour.
  • History of other malignancies within the last 5 years.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
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  • 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.
  • 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).
  • Patients who are pregnant or breastfeeding, or expecting to conceive .
  • 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.
  • Patients with known positive test for human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
  • 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).
  • Received a live virus vaccine within 30 days of planned start of study treatment.
  • Has had an allogeneic tissue/solid organ transplant.
  • Long-term oral steroids, more than 10 mg/day of methandrostenolone or similar, must be stopped for 28 days before entry into the group.
  • 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).
  • 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.
  • 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.
  • 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.
  • History of severe allergy, sensitisation or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins.
  • Patients who, in the opinion of the investigator, are otherwise unable to participate in this trial.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200011

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Tenth People's Hospital,Shanghai Tong Ji University School of Medicine

    Shanghai, Shanghai Municipality, 200072

  • Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200080

Other trials in China

About this study

Official title: A Phase I/II Single Arm Study of Intravesical Administration With Camrelizumab for High-risk Non-muscle Invasive Bladder Cancer(NMIBC) Failing in BCG Treatment

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.

Being tested
Camrelizumab
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Also called SHR-1210

    Solution for Infusion (Intravesical)

Study groups in NCT04706598
Study groupRoleWhat they receive
Intravesical therapy groupExperimentalCamrelizumab(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.
Receives: Drug: Camrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum dose of Camrelizumab for intravesical treatment

    The maximum tolerated dose (MTD) of Camrelizumab that will be given intravesically to patients with BCG-refractory NMIBC(de-escalated doses of 200/150/100mg) and recommended for phase II studies (RP2D).

    Measured: 3 months after trial initiation(Phase I)

  2. Event-Free Survival (EFS)

    Recurrence of high-grade cancer (TaHG, T1HG, CIS), or disease progression to stage T2 or beyond or lymph node metastasis or distant metastasis, or the need for other treatment (including systemic chemotherapy, radical cystectomy, radiation therapy), and death from any cause.

    Measured: 3 months after patient treatment (Phase II)

Secondary outcomes (5)

  1. Incidence of adverse events

    Incidence of adverse events and treatment-related adverse events

    Measured: Until progressive disease or death

  2. Assessment of HGRF

    High grade cancer recurrence free rate (HGFR) at 6 months and 1 year of treatment.

    Measured: 6 months and 1 year after patient enrollment

  3. Assessment of RFS

    Recurrence free survival (RFS) at 6 months and 1 year of treatment.

    Measured: 6 months and 1 year after patient enrollment

  4. Assessment of PFS

    Progression free survival (PFS) at 6 months and 1 year of treatment.

    Measured: 6 months and 1 year after patient enrollment

  5. the predictive value of PD-1 expresssion

    the predictive value of PD-L1 expression assessed in tumor tissue and urine sample obtained before and after Camrelizumab instillation.

    Measured: 1 year after patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start9 Jun 2021
  3. Primary completion11 Jul 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706598
Sponsor's protocol ID
MA-UC-II-004
Status last verified
Jul 2026
First submitted
27 Dec 2020
Last updated
20 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15126782

  • 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.

    PubMed 9933432

  • Mitropoulos DN. Novel insights into the mechanism of action of intravesical immunomodulators. In Vivo. 2005 May-Jun;19(3):611-21.

    PubMed 15875784

  • 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.

    PubMed 25800393

  • 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.

    PubMed 23452187

  • 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.

    PubMed 24948466

  • 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.

    PubMed 28796558

  • 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.

    PubMed 27324428

  • 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.

    PubMed 22575238

  • 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.

    PubMed 24357284

  • Inamura K. Bladder Cancer: New Insights into Its Molecular Pathology. Cancers (Basel). 2018 Apr 1;10(4):100. doi: 10.3390/cancers10040100.

    PubMed 29614760

  • 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.

    PubMed 3806806

  • 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.

    PubMed 28583311

  • Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971.

    PubMed 25838375

  • 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.

    PubMed 29368638

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Camrelizumab in people with Urinary Bladder Neoplasms and Immunotherapy, run by Fudan University at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum dose of Camrelizumab for intravesical treatment (time frame: 3 months after trial initiation(Phase I)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706598, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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