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Bladder CancerPhase 1NCT03106610

Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG Immunotherapy

A Phase 1 study testing Nivolumab and Questionnaires in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The goal of this clinical research study is to learn about the tolerability of nivolumab in patients who have bladder cancer, were previously treated with BCG immunotherapy, and who have a cystectomy (removal of all or part of the bladder) scheduled as part of their standard care. This is an investigational study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Nivolumab and Questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
7 Jul 2017to 16 May 2018
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Patients included in the study must be >/= 18 years old.
  • Histological or cytological evidence of transitional cell carcinoma or carcinoma in situ of the urothelium involving the bladder or prostatic urethra following treatment with BCG with the recommendation to proceed for cystectomy. Minor histologic variants (< 50% overall) are acceptable. Diagnosis must be within 1 year of study entry.
  • Patent must have BCG unresponsive non-muscle-invasive bladder cancer defined as: Persistent or recurrence of CIS within 12 months, or recurrence of CIS with Ta/T1 papillary disease within 12 months, or recurrence of high grade Ta or T1 papillary disease alone within 6 months of receiving at least two courses of intravesical BCG (at least five of six induction doses and at least two doses of either a maintenance course of BCG or a 2nd re-induction of BCG; or T1 high-grade disease at the first evaluation following induction of BCG alone (at least five of six induction doses).
  • Subjects must have received intravesical treatment with at least two doses of BCG within six months of nivolumab treatment initiation.
  • Evaluable tumor tissue (archived or new biopsy) must be available for pre-treatment biomarker analysis and baseline immune monitoring studies
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
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  • Screening laboratory values must meet the following criteria and must be obtained within 14 days prior to first dose: a) WBC >/= 2000/µL; b) Neutrophils >/= 1500/µL; c) Platelets >/= 100 x 10^3/mcl; d) Hemoglobin >/= 9.0 g/dL; e) AST and ALT </= 3 x ULN; f) Total Bilirubin </= 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
  • Inclusion 6) continued; g.Serum creatinine </=1.5 x ULN or creatinine clearance (CrCl) >/=30 mL/min (using the Cockcroft-Gault formula): 1) Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL; 2) Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL
  • Ability to understand and willingness to sign a written informed consent document.
  • Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized males must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. They must also refrain from egg cell donation for 180 days after the final dose of investigational product;
  • Inclusion 9) continued; a) Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)
  • Inclusion 9) continued; b) A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly. The acceptable methods of contraception are: Barrier Method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgestrel-releasing intrauterine system - Mirena®) or Hormonal Methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch).

Who cannot join

  • Patients with high risk muscle invasive urothelial carcinoma (hydronephrosis, palpable mass on examination under anesthesia,muscle invasive urothelial carcinoma with lymphovascular invasion on pathologic specimen, >T3 disease) or those with lymph node positive or metastatic disease are to be excluded.
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of PSA progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast for example.
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, anti-CD137, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
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  • All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 4).
  • Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.
  • Physical and Laboratory Test Findings; a) Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection; b) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Allergies and Adverse Drug Reaction; a) History of allergy to study drug components; b) History of severe hypersensitivity reaction to any monoclonal antibody.
  • Sex and Reproductive Status; a) Women of childbearing potential (WOCBP) who are pregnant or breastfeeding; b) Women with a positive pregnancy test at enrollment or prior to administration of study medication
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Pilot Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG Immunotherapy

The goal of this clinical research study is to learn about the tolerability of nivolumab in patients who have bladder cancer, were previously treated with BCG immunotherapy, and who have a cystectomy (removal of all or part of the bladder) scheduled as part of their standard care.

This is an investigational study. Nivolumab is FDA approved and commercially available to treat metastatic (has spread) melanoma or non-small cell lung cancer (NSCLC) after the disease has gotten worse while receiving platinum-based chemotherapy. The use of nivolumab in this study is considered investigational.

Up to 10 participants will take part in this study. All will be enrolled at MD Anderson.

Read the detailed description

Study Drug Administration:

Each study cycle is 14 days (2 weeks).

If you are found to be eligible to take part in this study, you will receive nivolumab by vein over about 60 minutes on Day 1 of Cycles 1-3.

Length of Study:

You may receive nivolumab for up to 3 cycles before your scheduled surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits (described below).

Study Visits

On Day 1 of Cycles 1-3 and at the visit before your surgery:

  • You will have a physical exam.
  • Blood (about 3-4 teaspoons) will be drawn for routine tests.
  • You will be asked to complete 2 quality-of-life questionnaires. These will take about 10 minutes to complete.
  • If you can become pregnant, urine or part of the above routine blood sample will be used for a pregnancy test.

Surgery (Cystectomy):

About 8 weeks after you join the study, you will have surgery for bladder cancer. You will sign a separate consent form that describes the surgery and its risks.

Follow Up:

About 4 weeks after surgery:

  • You will have a physical exam.
  • Blood (about 3-4 teaspoons) will be drawn for routine tests.
  • You will be asked to complete the 2 quality-of-life questionnaires.
Conditions
Bladder Cancer
Being tested
Nivolumab, Questionnaires
Keywords
Bladder cancer, Cancer of urothelium, Transitional cell carcinoma, Carcinoma in situ, Nivolumab, BMS-936558, Opdivo, Questionnaires, Surveys
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Carcinoma in Situ

What participants receive

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

  • NivolumabDrug

    Also called BMS-936558, Opdivo

    3 mg/kg of body weight by vein over about 60 minutes on Day 1 of Cycles 1-3.

  • QuestionnairesBehavioural

    Also called Surveys

    2 quality-of-life questionnaires completed on Day 1 of Cycles 1-3, at the visit before surgery, and 4 weeks after surgery.

Study groups in NCT03106610
Study groupRoleWhat they receive
NivolumabExperimentalParticipants receive Nivolumab by vein over about 60 minutes on Day 1 of Cycles 1-3 before scheduled surgery. Each study cycle is 14 days (2 weeks). Questionnaires completed on Day 1 of Cycles 1-3, at the visit before surgery, and 4 weeks after surgery.
Receives: Drug: Nivolumab; Behavioral: Questionnaires

What is being measured

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

  1. Safety of Nivolumab in Subjects Previously Treated with Intravesical Bacillus Calmette-Guerin (BCG) Immunotherapy assessed per NCI CTCAE version 4

    Safety assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Tolerability of Nivolumab in Subjects Previously Treated with Intravesical Bacillus Calmette-Guerin (BCG) Immunotherapy assessed using AUASS

    Tolerability assessed by measurement of local urinary symptoms using the American Urological Association Symptom Score (AUASS).

    Measured: 12 weeks

  2. Systemic Symptom Burden of Nivolumab in Subjects Previously Treated with Intravesical Bacillus Calmette-Guerin (BCG) Immunotherapy assessed using MDASI

    Systemic symptom burden assessed using the MD Anderson Symptom Inventory (MDASI).

    Measured: 12 weeks

Timeline

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

  1. First posted10 Apr 2017
  2. Study start7 Jul 2017
  3. Primary completion16 May 2018
  4. Study completion16 May 2018

Why it stopped: Slow Accrual

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03106610
Sponsor's protocol ID
2016-0432
Other IDs
NCI-2017-00647
Status last verified
May 2018
First submitted
30 Mar 2017
Last updated
24 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nivolumab and Questionnaires in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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.

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

Are results available for this study?

The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.

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?

Safety of Nivolumab in Subjects Previously Treated with Intravesical Bacillus Calmette-Guerin (BCG) Immunotherapy assessed per NCI CTCAE version 4 (time frame: 12 weeks). 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 NCT03106610.

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 24 May 2018.

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