Avelumab + AVB-S6-500 for Bladder Cancer

(COAXIN Trial)

Overseen By Ingrid Block

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Oklahoma

Must not be taking: Anti-PD-1, PD-L1, Corticosteroids, Immunosuppressants

Disqualifiers: Active infection, Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

19 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to test the safety of avelumab and AVB-S6-500 and see what effects (good and bad) this combination treatment has on patients with advanced urothelial carcinoma.

Research Team

Abhishek Tripathi, MD

Principal Investigator

Stephenson Cancer Center

Eligibility Criteria

Adults over 18 with advanced urothelial cancer that's inoperable or has spread, and who have already had platinum-based chemo but the cancer got worse. They must be able to perform daily activities with some limitations (ECOG ≤2), provide a tumor sample, and agree to contraception. Excluded are those on recent anticancer drugs, steroids, or with certain other health issues like untreated brain metastases or active infections.

Inclusion Criteria

My cancer progressed after platinum-based treatment.

Patients who are able to understand and sign the informed consent form.

Ability to comply with protocol

Exclusion Criteria

I haven't taken high-dose steroids or immunosuppressants in the last 28 days.

Pregnant or lactating, or intending to become pregnant during the study

I have not received a live vaccine recently and do not plan to during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive avelumab and AVB-S6-500 by vein every two weeks. Dose adjustments are made based on the dose level enrolled.

up to 2 years

Bi-weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion for up to one year

up to 1 year

Treatment Details

Interventions

• AVB-S6-500
• Avelumab

Trial Overview The trial is testing the safety and effects of combining two treatments: Avelumab (an immunotherapy drug) and AVB-S6-500 (a new therapy) for patients whose bladder cancer has worsened after chemotherapy. The goal is to see if this combination helps more than current treatments.

Participant Groups

Group I: Avelumab + AVB-S6-500 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Aravive, Inc.

Industry Sponsor

Trials

9

Recruited

590+

EMD Serono

Industry Sponsor

Trials

147

Recruited

27,800+

Dr. Shepard

EMD Serono

Chief Medical Officer since 2021

MD from University of Cincinnati Medical School, Fellowships in Hematology and Oncology at University of Chicago Hospitals and Clinics

Miguel Fernández Alcalde

EMD Serono

Chief Executive Officer

Bachelor's Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master's Degree in Management from IESE Business School