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Monoclonal Antibodies

Avelumab + Taxane for Bladder Cancer

Phase 1
Waitlist Available
Led By Yousef Zakharia, MD
Research Sponsored by Yousef Zakharia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematologic function defined by specific white blood cell, neutrophil, lymphocyte, platelet, and hemoglobin counts
Adequate renal function defined by calculated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment up to 5 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of combining two drugs, Avelumab and Docetaxel, to treat patients with metastatic urothelial cancer.

Who is the study for?
This trial is for adults aged 18-85 with advanced or metastatic urothelial cancer, who can't have cisplatin-based chemo due to health issues or whose cancer has worsened after such treatment. Participants need a certain level of physical fitness and organ function, must not be pregnant, agree to use effective contraception, and cannot have immune conditions or recent major illnesses.Check my eligibility
What is being tested?
The AVETAX study tests the combination of Avelumab (an antibody targeting PD-L1) with Docetaxel (a type of chemotherapy), in patients with urothelial cancer that's spread and isn't responding well to standard treatments. The goal is to see if this combo is safe and works better than current options.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, infusion reactions from the antibody treatment, typical chemo side effects like fatigue, nausea, low blood counts leading to increased infection risk. Each patient may experience these differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood test results are within the normal range.
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My kidneys work well enough, with a creatinine clearance over 30 mL/min.
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I am fully active or can carry out light work.
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My liver is functioning well, according to recent tests.
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I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose De-Escalation Phase: To assess dose limiting toxicities (DLTs) using CTCAE v4.03.
Dose Expansion Phase: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) per RECIST v1.1
Secondary outcome measures
Dose Expansion: To determine ORR per RECIST v1.1
Dose Expansion: To determine radiologic progression-free survival (PFS) per RECIST v1.1 and immune RECIST criteria

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Avelumab and DocetaxelExperimental Treatment2 Interventions
Induction phase: Avelumab (10 mg/kg) + Docetaxel (75 mg/m2) every 3 weeks for 6 cycles Maintenance phase: Avelumab (10 mg/kg) every 2 weeks until disease progression or toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Avelumab
FDA approved

Find a Location

Who is running the clinical trial?

Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
174 Total Patients Enrolled
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,662 Total Patients Enrolled
University of IowaOTHER
443 Previous Clinical Trials
878,669 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03575013 — Phase 1
Bladder Cancer Research Study Groups: Avelumab and Docetaxel
Bladder Cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03575013 — Phase 1
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03575013 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of enrollment into this experiment?

"At the present moment, this medical trial is not accepting patient participants. It was first opened on October 29th 2018 and last modified on October 18th 2022. However, if one is searching for other clinical studies, there are 214 trials related to carcinoma transitional cell recruiting candidates as well as 430 trials involving docetaxel actively seeking individuals."

Answered by AI

Has the U.S. Food and Drug Administration given their stamp of approval to Docetaxel?

"An assessment of the safety profile for Docetaxel revealed a score of 1, indicating that this is an early-phase trial with limited evidence supporting its effectiveness and risk mitigation."

Answered by AI

Has Docetaxel been the focus of any prior research initiatives?

"At the moment, there are 430 ongoing studies researching Docetaxel. Of those active trials, 136 have advanced to Phase 3 status. While Fuzhou, Fujian is home to a majority of these experiments, 26 066 clinical sites around the world are evaluating this treatment option."

Answered by AI

Are there any available slots for participants in this trial?

"As of October 18th 2022, this clinical trial is no longer accepting new candidates. It was initially posted on October 29th 2018 and has since been edited multiple times. However, there are currently 214 trails for carcinoma transitional cell patients seeking participation as well as 430 studies involving docetaxel actively recruiting participants."

Answered by AI

To what end is Docetaxel typically employed?

"Docetaxel is commonly used to tackle soft tissue sarcomas, and it has proven useful for treating other pathological processes such as neoplasm metastasis, BRCA1 gene mutations, and advanced directives."

Answered by AI
~3 spots leftby Mar 2025