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

NCT03892642 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: OU-SCC-ABC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

Intravesical BCG; Bacille Calmette-Guerin; avelumab

Outcome Measures

Primary Outcomes (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

  8 weeks

Secondary Outcomes (7)

• Proportion of Patients Receiving Complete Induction Course

  5 weeks

• Percent of Patients With Complete Response

  3 months

• Proportion of Patients With Complete Response

  6 months

• Percent of Patients With Recurrence Free Survival

  6 months

• Proportion of Patients With Recurrence Free Survival

  12 months

Study Arms (1)

BCG + Avelumab

EXPERIMENTAL

Combination 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.

Drug: Avelumab; Biological: BCG

Interventions

Avelumab DRUG

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

BCG + Avelumab

BCG BIOLOGICAL

Induction phase (cycle 1): • Once weekly for weeks 1-6 Maintenance phase (Month 3, 6, and 12): • Once weekly for 3 weeks

Also known as: Bacille Calmette-Guérin

BCG + Avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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
• a. 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

Sponsors & Collaborators

• University of Oklahoma: lead
• EMD Serono: collaborator

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

avelumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Associate Professor
• Organization: OU Health Stephenson Cancer Center

kelly-stratton@ouhsc.edu

405-271-6900

Study Officials

• Kelly Stratton, MD

  Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 27, 2019
• Study Start: May 1, 2019
• Primary Completion: March 23, 2021
• Study Completion: August 13, 2023
• Last Updated: February 14, 2024
• Results First Posted: April 25, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)