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PD-L1 Inhibitor
Cabozantinib + Atezolizumab for Bladder Cancer (ABATE Trial)
Phase 2
Recruiting
Led By Deepak Kilari, MD
Research Sponsored by Deepak Kilari
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No radiation therapy < 4 weeks of registration. NOTE: prior radiation therapy to the bladder is not allowed.
ECOG Performance Status of ≤ 2 within 28 days prior to registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
ABATE Trial Summary
This trial is testing whether a combination of two drugs, cabozantinib and atezolizumab, is effective in treating patients with urothelial carcinoma who are ineligible for or decline cisplatin-based therapy.
Who is the study for?
Adults with muscle-invasive bladder cancer who can't have or don't want cisplatin-based therapy. They should be fit for surgery, not pregnant, willing to use contraception, and free from HIV/AIDS, severe infections, other active cancers (except certain cases), significant heart disease, and uncontrolled illnesses. Prior treatments and allergies to study drugs are also considered.Check my eligibility
What is being tested?
The trial tests cabozantinib taken orally daily combined with atezolizumab given intravenously every three weeks in patients before they undergo cystectomy. The goal is to see how well these drugs work together against bladder cancer when cisplatin isn't an option.See study design
What are the potential side effects?
Possible side effects include liver problems, high blood pressure, bleeding issues, fatigue, mouth sores, hand-foot syndrome (redness and pain on palms or soles), taste changes, poor appetite leading to weight loss; plus typical immune-related side effects like rash or thyroid issues.
ABATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had radiation therapy in the last 4 weeks, especially not to the bladder.
Select...
I have been mostly active in the last month.
Select...
My cancer is mostly urothelial carcinoma and does not have neuroendocrine features.
Select...
I am 18 years old or older.
Select...
I cannot have cisplatin due to health issues or personal choice.
Select...
My cancer has not spread beyond its original site.
Select...
My cancer is at a stage where it has grown but not spread to distant organs.
ABATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Response Rate
Secondary outcome measures
Event Free Survival
Frequency and Severity of Adverse Events
Pathologic complete response rate
Side effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
RASH
5%
Hoarseness
5%
INSOMNIA
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Peripheral Sensory Neuropathy
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
ABATE Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment3 Interventions
Cabozantinib 40 mg orally daily x 9 weeks plus Atezolizumab 1200 mg every 3 weeks x 3 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cystectomy
2014
Completed Phase 2
~120
Atezolizumab
2017
Completed Phase 3
~5860
Cabozantinib
2020
Completed Phase 2
~1760
Find a Location
Who is running the clinical trial?
Deepak KilariLead Sponsor
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,505 Total Patients Enrolled
Medical College of WisconsinOTHER
610 Previous Clinical Trials
1,162,667 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation therapy in the last 4 weeks, especially not to the bladder.I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after the study.You have a history of severe allergic reactions to certain types of medications, or rare hereditary problems with digesting certain sugars.I am allergic to certain medications made in specific lab conditions or their ingredients.I haven't taken antibiotics for treatment in the last 2 weeks, only for prevention.My surgeon agrees I can undergo major bladder surgery.I do not have active hepatitis B according to my screening tests.I have a history of specific lung conditions or signs of lung inflammation on my chest scan.I have been mostly active in the last month.I have had a stem cell or organ transplant in the past.My cancer is mostly urothelial carcinoma and does not have neuroendocrine features.You must have a negative hepatitis C core antibody test or a positive test followed by a negative hepatitis C virus DNA test.I agree to use two forms of birth control or abstain from sex, and not to donate sperm or breastfeed for 5 months after treatment ends.You have taken certain medications that boost the immune system or suppress it within a specific timeframe. You have a history of certain autoimmune diseases, except for specific conditions that are managed well.I have no active cancer needing treatment, except for certain low-risk types or those in remission for 5+ years.I am 18 years old or older.My recent tests show my organs are functioning well.I am a woman who can have children and have a recent negative pregnancy test.My bladder cancer has invaded muscle or prostate but not muscle.I understand and can follow the study's procedures.I cannot have cisplatin due to health issues or personal choice.You have a history of significant heart disease, recent heart attacks, unstable angina, stroke, or other serious vascular issues. If you have certain heart conditions, you can only participate if your treatment is stable and your doctor thinks it's safe. You also shouldn't have uncontrolled fluid build-up around your organs, certain types of pain, or any other health issues that could be made worse by the study drug.My cancer has not spread beyond its original site.I have not had a severe infection in the last 4 weeks.I have recovered from side effects of my previous cancer treatment.I am currently on medication for an infection.I can provide tissue samples from previous tests if they are available.I do not have HIV, or if I do, it is under control with treatment.Criterion: You have uncontrolled high blood pressure, certain gastrointestinal disorders, active bleeding, severe liver problems, or certain heart rhythm issues, among other conditions.I do not have active tuberculosis.I have been treated with cabozantinib before.My cancer is at a stage where it has grown but not spread to distant organs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what end is Cabozantinib usually prescribed?
"Cabozantinib is traditionally prescribed to treat small cell lung cancer (SCLC). Its efficacy, however, extends beyond this application and it can be a viable option for subjects that have been previously treated with anti-VEGF medications or those who are deemed as high risk patients."
Answered by AI
What is the current enrollment capacity for this experiment?
"This clinical trial requires 42 qualified participants, and the sponsor Genentech Inc. will be conducting it across various sites including University of Rochester Medical Center in Rochester, NY and John Theurer Cancer Center in Hackensack, NJ."
Answered by AI
How many centers are currently managing this clinical trial?
"This trial can be found at University of Rochester Medical Center in Rochester, John Theurer Cancer Center in Hackensack, Vanderbilt-Ingram Cancer Center in Nashville and a further 5 different medical institutions."
Answered by AI
Has Cabozantinib been given the green light by the FDA?
"Cabozantinib's safety was rated a 2 due to the presence of Phase 2 clinical data suggesting its security, but no proof that it is effective."
Answered by AI
Is this exploration unprecedented in its approach?
"To date, 447 trials are underway for the drug cabozantinib across 75 countries and 1910 cities. The initial study began in 2008 as part of Hoffmann-La Roche's Phase 2 approval process with 720 participants; since its launch, a further 138 studies have been conducted."
Answered by AI
Can any participants join this clinical experiment at present?
"As indicated by clinicaltrials.gov, this medical trial is presently seeking participants. This research endeavour was initially listed on May 21st 2020 and has since been amended on August 26th 2022."
Answered by AI
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