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Monoclonal Antibodies
Avelumab + Taxane for Bladder Cancer
Iowa City, IA
Phase 1
Waitlist Available
Led By Rohan Garje, 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
Must not have
Concurrent treatment with an anticancer treatment
Prior therapy with any drug targeting T cell coregulatory proteins
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment up to 5 years
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing the safety and effectiveness of combining two drugs, Avelumab and Docetaxel, to treat patients with metastatic urothelial cancer.
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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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving treatment for cancer.
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I have been treated with drugs that target immune system proteins.
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I have not had major surgery in the last 4 weeks or am fully recovered if I did.
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I am mentally capable of understanding and giving informed consent.
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I haven't taken steroids, immunosuppressants, or experimental drugs in the last 28 days.
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I do not have severe chronic conditions like immune colitis or psychiatric issues.
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I have had an organ or stem-cell transplant.
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I have or had an autoimmune disease or immune deficiency.
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I have a serious heart condition.
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I have active brain tumors.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
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
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Closest Location:University of Iowa Hospitals and Clinics· Iowa City, IA· 462 miles
Who is running the clinical trial?
University of IowaOTHER
483 Previous Clinical Trials
933,484 Total Patients Enrolled
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
140 Total Patients Enrolled
PfizerIndustry Sponsor
4,705 Previous Clinical Trials
50,981,608 Total Patients Enrolled
Rohan GarjeLead Sponsor
1 Previous Clinical Trials
Rohan Garje, MDPrincipal InvestigatorUniversity of Iowa
Yousef Zakharia, MDPrincipal InvestigatorUniversity of Iowa
4 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for cancer.I have been treated with drugs that target immune system proteins.I have not had major surgery in the last 4 weeks or am fully recovered if I did.I am mentally capable of understanding and giving informed consent.My bladder cancer got worse after platinum treatment or I couldn't have cisplatin.My blood test results are within the normal range.My kidneys work well enough, with a creatinine clearance over 30 mL/min.I haven't taken steroids, immunosuppressants, or experimental drugs in the last 28 days.I have lasting side effects from past treatments, but only mild ones except for some nerve issues.I do not have severe chronic conditions like immune colitis or psychiatric issues.I have not received any vaccines within 4 weeks before starting Avelumab, except for inactivated ones.I am fully active or can carry out light work.My liver is functioning well, according to recent tests.I haven't had cancer, other than bladder cancer, in the last 5 years.I am between 18 and 85 years old.I have had an organ or stem-cell transplant.I have or had an autoimmune disease or immune deficiency.I am willing to use effective birth control during and for 30 days after the study.My cancer is mainly urothelial and has spread beyond where it started.I have a serious heart condition.I have active brain tumors.
Research Study Groups:
This trial has the following groups:- Group 1: Avelumab and Docetaxel
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.