Urothelial CarcinomaPhase 1COAXINNCT04004442
Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma
A Phase 1 study testing Avelumab and AVB-S6-500 in people with Urothelial Carcinoma, run by University of Oklahoma at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Avelumab and AVB-S6-500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to Oct 2026
- Phase
- Phase 1
- 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 locally advanced unresectable (T4b or N2/N3 disease) or metastatic urothelial cancer (including renal pelvis, ureters, urinary bladder, urethra).
- Eligible patients must have had either:
- Progressed after treatment with at least 1 prior platinum-containing regimen, (e.g., received at least 2 cycles of cisplatin or carboplatin-based regimen) for inoperable locally advanced unresectable or metastatic urothelial carcinoma, OR OR
- Experienced disease progression or recurrence within 12 months of completion of neoadjuvant or adjuvant cisplatin-based chemotherapy, OR OR
- Ineligible for cisplatin-based chemotherapy due to eastern co-operative oncology group (ECOG) performance status 2, grade ≥2 neuropathy, GFR<60 mL/min, grade ≥2 hearing loss or New York Heart Association class III or worse congestive heart failure.
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- Declined platinum (cisplatin or carboplatin) based chemotherapy after informed discussion with the treating investigator
- Available pretreatment baseline tumor specimen or willingness to undergo biopsy of primary or metastatic lesion if archived specimen is not available.
- ECOG performance status of ≤2
- At least one measurable lesion by RECIST version 1.1
- Patients who are able to understand and sign the informed consent form.
- Ability to comply with protocol
- 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
- Concurrent systemic treatment with an anticancer treatment or investigational drug within 28 days. Palliative radiation to symptomatic primary tumor or metastases is permitted as long as there are other measurable lesions present outside of the radiation field.
- Prior therapy with anti-PD-1 or PD-L1 agents.
- Concurrent systemic therapy with corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive agents within 28 days before starting trial drug. Short-term administration of systemic steroids (less than 7 days), adrenal replacement steroid doses (≤10 mg daily prednisone equivalent), topical, intranasal and inhaled steroid use is permitted.
- Patients with untreated or symptomatic central nervous metastases will be excluded. Patients appropriately treated with either surgery and/or radiation therapy will be eligible to participate in the study 4 weeks after completion of radiation/surgery and if follow up brain imaging after CNS directed therapy demonstrates stability or improvement in brain metastases.
- Active second malignancy or previous history of malignant disease (other than urothelial carcinoma) diagnosed within the last 3 years, with the exclusion of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ and pT2 prostate adenocarcinoma with Gleason score ≤7 (with no dominant pattern 4).
- Prior organ transplantation, including allogenic stem-cell transplantation.
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- Known history of HBV infection (including acute and chronic infection) and untreated hepatitis C. Patients with treated HCV infection will be eligible.
- Known hypersensitivity to monoclonal antibody or any biologic drug, history of anaphylaxis, or uncontrolled asthma.
- Persisting toxicity related to prior therapy that was > grade 1 according to NCI-CTCAE v4; grade ≤2 sensory neuropathy is allowed.
- 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 pregnancy test result within 14 days prior to the first dose of study treatment.
- Diagnosis of active autoimmune disease requiring systemic immunosuppression. Patients with type 1 diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring systemic immunosuppression are eligible.
- 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 fibrosis in the radiation field (fibrosis) is permitted.
- 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
- 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 including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase I Study of Avelumab in Combination With AXL Inhibitor AVB-S6-500 in Patients With Advanced Urothelial Carcinoma
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.
Read the detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with avelumab and AVB-S6-500 by vein once every two weeks.
This study has two parts in order to determine the maximum tolerated dose of AVB-S6-500. If the patient is enrolled on the first dose level, the patient will be treated at a higher dose every two weeks with AVB-S6-500. If the patient is enrolled on the second dose level, the patient will be receive AVB-S6-500 only once a week at a lower dose. The patient would continue to receive avelumab twice weekly at the same dose.
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects.
Patients will be monitored during treatment with tests and exams and after treatment completion for up to one year.
- Conditions
- Urothelial Carcinoma
- Being tested
- Avelumab, AVB-S6-500
- Keywords
- avelumab, AVB-S6-500, renal pelvis cancer, ureter cancer, urinary bladder cancer, urethra cancer
- Medical subject headings
- Carcinoma, Transitional Cell, Ureteral Neoplasms, Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Avelumab: 800 mg IV every two weeks (on days 1 and 15 of a 28-day cycle)
AVB-S6-500Drug
AVB-S6-500: 10mg/kg IV every 2 weeks (on days 1 and 15 of a 28-day cycle) Potential dose reduction: AVB-S6-500: 5mg/kg IV weekly (on days 1, 8, 15 and 22 of a 28-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| Avelumab + AVB-S6-500 | Experimental | Not described Receives: Drug: Avelumab; Drug: AVB-S6-500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To investigate the safety and tolerability of the study drug combination for Avelumab with AVB-S6-500
Measured: up to 2 years
Secondary outcomes (5)
Progression Free Survival
period from the time of patient enrollment until disease progression, death, or date of last contact or to the date of censoring (dropout, end of study or death)
Measured: up to two years
Clinical Benefit Rate
proportion of patients with complete or partial response, or stable disease per RECIST 1.1 on treatment with avelumab and ABV-S6-500
Measured: up to two years
Duration of Response
defined as the period from the date of confirmed tumor response until disease progression, death, or date of last contact or to the date of censoring (dropout, end of study or death)
Measured: up to two years
Overall Survival
the period from patient enrollment until death, or date of last contact or to the date of censoring (end of study)
Measured: up to two years
Investigator assessed Objective Response Rate
To evaluate the antitumor efficacy of avelumab and AVB-S6-500 as measured by the objective response rate assessed by the investigator
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start17 Feb 2020
- Primary completion7 Apr 2022
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Aravive, Inc., EMD Serono
- Responsible party
- Sponsor
- Investigators
- Abhishek Tripathi, MD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004442
- Sponsor's protocol ID
- OU-SCC-COAXIN
- Acronym
- COAXIN
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Avelumab in Combination With AXL Inhibitor AVB-S6-500 in Patients With Advanced Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04004442
- Acronym / sponsor ID
- COAXIN / OU-SCC-COAXIN
- Conditions
- Urothelial Carcinoma
- Keywords
- avelumab, AVB-S6-500, renal pelvis cancer, ureter cancer, urinary bladder cancer, urethra cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Aravive, Inc., EMD Serono
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with avelumab and AVB-S6-500 by vein once every two weeks.
This study has two parts in order to determine the maximum tolerated dose of AVB-S6-500. If the patient is enrolled on the first dose level, the patient will be treated at a higher dose every two weeks with AVB-S6-500. If the patient is enrolled on the second dose level, the patient will be receive AVB-S6-500 only once a week at a lower dose. The patient would continue to receive avelumab twice weekly at the same dose.
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects.
Patients will be monitored during treatment with tests and exams and after treatment completion for up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avelumab + AVB-S6-500 | Experimental | Drug: Avelumab, Drug: AVB-S6-500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years
- Histologically confirmed locally advanced unresectable (T4b or N2/N3 disease) or metastatic urothelial cancer (including renal pelvis, ureters, urinary bladder, urethra).
- Eligible patients must have had either:
- Available pretreatment baseline tumor specimen or willingness to undergo biopsy of primary or metastatic lesion if archived specimen is not available.
- ECOG performance status of ≤2
Key exclusion criteria (18 listed)
- Concurrent systemic treatment with an anticancer treatment or investigational drug within 28 days. Palliative radiation to symptomatic primary tumor or metastases is permitted as long as there are other measurable lesions present outside of the radiation field.
- Prior therapy with anti-PD-1 or PD-L1 agents.
- Concurrent systemic therapy with corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive agents within 28 days before starting trial drug. Short-term administration of systemic steroids (less than 7 days), adrenal replacement steroid doses (≤10 mg daily prednisone equivalent), topical, intranasal and inhaled steroid use is permitted.
- Patients with untreated or symptomatic central nervous metastases will be excluded. Patients appropriately treated with either surgery and/or radiation therapy will be eligible to participate in the study 4 weeks after completion of radiation/surgery and if follow up brain imaging after CNS directed therapy demonstrates stability or improvement in brain metastases.
- Active second malignancy or previous history of malignant disease (other than urothelial carcinoma) diagnosed within the last 3 years, with the exclusion of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ and pT2 prostate adenocarcinoma with Gleason score ≤7 (with no dominant pattern 4).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAvelumab: 800 mg IV every two weeks (on days 1 and 15 of a 28-day cycle) | Drug | Avelumab + AVB-S6-500 |
| AVB-S6-500AVB-S6-500: 10mg/kg IV every 2 weeks (on days 1 and 15 of a 28-day cycle) Potential dose reduction: AVB-S6-500: 5mg/kg IV weekly (on days 1, 8, 15 and 22 of a 28-day cycle) | Drug | Avelumab + AVB-S6-500 |
Primary outcome
Safety and Tolerability
Time frame: up to 2 years
To investigate the safety and tolerability of the study drug combination for Avelumab with AVB-S6-500
5 secondary outcomes
Progression Free Survival
Time frame: up to two years
Clinical Benefit Rate
Time frame: up to two years
Duration of Response
Time frame: up to two years
Overall Survival
Time frame: up to two years
Investigator assessed Objective Response Rate
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhishek Tripathi, MD principal investigator
Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avelumab and AVB-S6-500 in people with Urothelial Carcinoma, 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 15 inclusion and 18 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 13 Mar 2026. 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?
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?
Safety and Tolerability (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.