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Bladder CancerPhase 1/2OU-SCC-ABCNCT03892642

Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer

A Phase 1/2 study testing Avelumab and BCG in people with Bladder Cancer, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the safety of avelumab and Bacille Calmette-Guerin (BCG) and see what effects (good and bad) that this combination treatment has on subjects with recurrent bladder cancer. 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?
Avelumab and BCG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
1 May 2019to 13 Aug 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically documented Non-muscle Invasive Bladder Cancer (NMIBC)
  • Patient with BCG-treated but unresponsive NMIBC (persistent or recurrent defined as tumor lesion present after prior response).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2.
  • Patients who are able to understand and sign the informed consent form.
  • Age ≥ 18 years old
  • Ability to comply with protocol
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  • Life expectancy >/=12 weeks
  • Adequate hematologic and end-organ function per protocol
  • For women of childbearing potential: Negative serum or urine pregnancy test at screening.
  • For both male and female subjects: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 30 days after the last dose of study drug.

Who cannot join

  • Evidence of locally advanced or metastatic bladder cancer (including current disease involving renal pelvis, ureter, or prostatic urethra).
  • Evidence of muscle-invasive bladder cancer
  • Evidence of extravesical bladder cancer
  • Active central nervous system (CNS) metastases.
  • Prior treatment with PD-L1 or PD-1 inhibitor.
  • Prior radiation to bladder
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  • Known additional malignancy that required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin.
  • Patient is considered a poor medical risk that would interfere with cooperation with the requirements of the study.
  • Patient has a condition or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
  • Patient has not recovered (i.e, to ≤Grade 1 or to baseline) from previous intravesical BCG or other anti-cancer therapy induced AEs.
  • Treatment with any approved anti-cancer therapy, including chemotherapy (systemic or intravesical), radiation therapy, or hormonal therapy within 3 weeks prior to the first dose of study treatment
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 4 weeks prior to the first dose of study treatment
  • Pregnant or lactating, or intending to become pregnant during the study
  • Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to the first dose of study treatment.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
  • Allergy or hypersensitivity to components of the avelumab formulation
  • History of autoimmune disease defined per protocol
  • Prior allogeneic stem cell or solid organ transplantation
  • Current use of immunosuppressive medication defined per protocol
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Positive test for HIV
  • Active hepatitis B (positive hepatitis B surface antigen [HBsAg] test at screening);
  • Patients with past or resolved hepatitis B (HBV) infection (positive anti-hepatitis B core antigen [anti-HBc] antibody test) are eligible. HBV DNA must be obtained in these patients prior to the first dose of study treatment.
  • Active hepatitis C
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay is negative for HCV RNA.
  • Active infection requiring systemic therapy
  • Severe infections within 4 weeks prior to the first dose of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Significant cardiovascular disease, such as cerebral vascular accident/stroke (< 6 months prior to enrollment), New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina
  • Administration of a live/attenuated vaccine within 4 weeks prior to the first dose of study treatment, within 5 months following the administration of the last dose of study drug, or anticipation that such a live/attenuated vaccine will be required during the study
  • Other severe acute or chronic medical conditions defined per protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Phase Ib Study of Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (ABC Trial)

The purpose of this study is to test the safety of avelumab and Bacille Calmette-Guerin (BCG) and see what effects (good and bad) that this combination treatment has on subjects with recurrent bladder cancer.

Read the detailed description

There will be exams, tests and procedures to see if the patient is eligible for the study. Some are part of regular cancer care and others are part of the study. Subjects will also need to complete a research questionnaire at certain points in the study.

Subjects will receive treatment of avelumab and intravesical BCG until unacceptable toxicity or tumor progression.

Study participation is up to three years.

Conditions
Bladder Cancer
Being tested
Avelumab, BCG
Keywords
Intravesical BCG, Bacille Calmette-Guerin, avelumab
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.

  • AvelumabDrug

    Induction phase:

    • once weekly for weeks 1-6,
    • once every 2 weeks at week 8, 10, and 12

    Maintenance phase:

    • Once every week for weeks 1-3
    • Once every 2 weeks starting at week 5, until the next BCG treatment

  • BCGBiological

    Also called Bacille Calmette-Guérin

    Induction phase (cycle 1):

    • Once weekly for weeks 1-6

    Maintenance phase (Month 3, 6, and 12):

    • Once weekly for 3 weeks
Study groups in NCT03892642
Study groupRoleWhat they receive
BCG + AvelumabExperimentalCombination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.
Receives: Drug: Avelumab; Biological: BCG

What is being measured

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

  1. Proportion of Patients Receiving Complete Induction Course

    Proportion of patients receiving complete induction course, defined as freedom from DLT preventing completion of at least 5 of 6 treatments of BCG + avelumab

    Measured: 8 weeks

Secondary outcomes (7)

  1. Proportion of Patients Receiving Complete Induction Course

    completion of at least 2 of 3 treatments within each 5 week period

    Measured: 5 weeks

  2. Percent of Patients With Complete Response

    based on negative cystoscopy and urine cytology. A negative biopsy at 6 months will provide evidence of complete response.

    Measured: 3 months

  3. Proportion of Patients With Complete Response

    based on negative cystoscopy and urine cytology. A negative biopsy at 6 months will provide evidence of complete response.

    Measured: 6 months

  4. Percent of Patients With Recurrence Free Survival

    defined as percent of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy.

    Measured: 6 months

  5. Proportion of Patients With Recurrence Free Survival

    defined as proportion of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy

    Measured: 12 months

  6. Proportion of Patients With Progression-free Survival

    defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause

    Measured: 6 months

  7. Proportion of Patients With Progression-free Survival

    defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause

    Measured: 12 months

Timeline

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

  1. First posted27 Mar 2019
  2. Study start1 May 2019
  3. Primary completion23 Mar 2021
  4. Study completion13 Aug 2023

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03892642
Sponsor's protocol ID
OU-SCC-ABC
Other IDs
OU-SCC-ABC
Acronym
OU-SCC-ABC
Status last verified
Feb 2024
First submitted
7 Feb 2019
Last updated
14 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Avelumab and BCG in people with Bladder Cancer, run by University of Oklahoma 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 10 inclusion and 32 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: finished, as of the sponsor's last update on 14 Feb 2024. 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 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?

Yes. Results are posted in the registry (first posted 25 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Patients Receiving Complete Induction Course (time frame: 8 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 NCT03892642.

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 14 Feb 2024.

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