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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.
Must not have
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the study or within 5 months after the last dose of study drug.
Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab or cabozantinib formulation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
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I have been mostly active in the last month.
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My cancer is mostly urothelial carcinoma and does not have neuroendocrine features.
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I am 18 years old or older.
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I cannot have cisplatin due to health issues or personal choice.
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My cancer has not spread beyond its original site.
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My cancer is at a stage where it has grown but not spread to distant organs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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.
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I am allergic to certain medications made in specific lab conditions or their ingredients.
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I have a history of specific lung conditions or signs of lung inflammation on my chest scan.
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I have had a stem cell or organ transplant in the past.
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I have not had a severe infection in the last 4 weeks.
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I am currently on medication for an infection.
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Criterion: You have uncontrolled high blood pressure, certain gastrointestinal disorders, active bleeding, severe liver problems, or certain heart rhythm issues, among other conditions.
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I do not have active tuberculosis.
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I have been treated with cabozantinib before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic Response Rate
Secondary study objectives
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%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
NAUSEA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
Decreased Platelet Count
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
Upper Respiratory Infection
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Pruritis
14%
HYPOGLYCEMIA
14%
Rash Maculopapular
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
ALKALINE PHOSPHATASE INCREASED
9%
Papulopustular Rash
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
TUMOR PAIN
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Investigations - Other, International Normalized Ration Increased
5%
Allergic Rhinitis
5%
Hypotension
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
JOINT RANGE OF MOTION DECREASED
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Joint Range Of Motion Decreased
5%
HYPOMAGNESEMIA
5%
HEMATURIA
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Scalp Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
SKIN INFECTION
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Muscle Weakness Upper Limb
5%
Neuropathy
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Breast Pain
5%
INSOMNIA
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Stomach Pain
5%
TENDONITIS
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Awards & Highlights
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: 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
Cabozantinib
2020
Completed Phase 2
~1760
Atezolizumab
2017
Completed Phase 3
~5850
Cystectomy
2014
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Deepak KilariLead Sponsor
ExelixisIndustry Sponsor
120 Previous Clinical Trials
20,069 Total Patients Enrolled
Medical College of WisconsinOTHER
627 Previous Clinical Trials
1,179,810 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.
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