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Monoclonal Antibody
Cabozantinib + Avelumab for Bladder Cancer
Phase 3
Waitlist Available
Led By Shilpa Gupta
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
None of the following: Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether adding cabozantinib to avelumab improves treatment of metastatic urothelial cancer.
Who is the study for?
Adults with advanced or metastatic urothelial cancer who've had one round of platinum-based chemo can join this trial. They must have stable health, no recent major surgeries, and not be on certain blood thinners or immunosuppressants. Women must test negative for pregnancy and all participants should use birth control to prevent pregnancy during the study.Check my eligibility
What is being tested?
The MAIN-CAV Study is testing if adding Cabozantinib to Avelumab improves treatment outcomes in metastatic urothelial cancer compared to Avelumab alone. It's a phase III trial where patients are randomly assigned to either receive both drugs or just the immunotherapy drug.See study design
What are the potential side effects?
Cabozantinib may cause fatigue, high blood pressure, hand-foot syndrome (redness and pain in hands/feet), mouth sores, diarrhea, decreased appetite and weight loss. Avelumab might lead to immune-related side effects like inflammation in organs such as lungs or intestines, skin reactions, hormone gland problems (like thyroid disorders), infusion reactions and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have an active autoimmune disease that could worsen with avelumab treatment.
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I do not have lung cavities or tumors inside my airways.
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I don't have any major health issues or recent serious illnesses.
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I am not taking blood thinners like warfarin, dabigatran, betrixaban, or clopidogrel.
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My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.
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I am 18 years old or older.
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My tumor responded to the first round of platinum-based chemotherapy.
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I am fully active or can carry out light work.
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I haven't had major surgery in the last 4 weeks and my surgical wounds have healed without ongoing complications.
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I've had 4-6 rounds of specific chemotherapy as my first treatment.
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My cancer originates from the urinary system and is not small-cell type.
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I am not pregnant or breastfeeding.
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I haven't had specific immune treatments for cancer.
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I haven't had significant bleeding or coughed up blood in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Incidence of adverse events (AE)
Progression free survival (PFS)
Tumor response
Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Activated Partial Thromboplastin Time Prolonged
15%
Sore Throat
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Generalized Muscle Weakness
8%
Allergic Rhinitis
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (avelumab, cabozantinib)Experimental Treatment8 Interventions
Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle and cabozantinib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial.
Group II: Arm A (avelumab)Active Control7 Interventions
Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Avelumab
2018
Completed Phase 2
~2450
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cabozantinib S-malate
2013
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,923,618 Total Patients Enrolled
Shilpa GuptaPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is at least 8 grams per deciliter.The amount of protein in your urine is within a certain range.I don't have active brain metastases and am stable if previously treated.I haven't taken strong immune-weakening medicines in the last week, except for minor exceptions like inhalers or low-dose steroids.I agree to use barrier contraception during and for 4 months after the study.I do not have an active autoimmune disease that could worsen with avelumab treatment.I haven't had a live vaccine in the last 30 days, but I may have had the COVID-19 vaccine or other inactivated vaccines.Your platelet count is at least 100,000 per cubic millimeter.I can swallow pills, have no severe uncontrolled conditions, and can understand and consent to treatment.I have a controlled autoimmune condition and take less than 10 mg of prednisone daily without immunosuppressants.I have not had palliative radiotherapy in the last 48 hours.I have had only one prior chemotherapy for my advanced disease, or it's been over a year since my last treatment.I do not have lung cavities or tumors inside my airways.I don't have any major health issues or recent serious illnesses.I have diabetes type I, vitiligo, psoriasis, or thyroid issues but don't need immunosuppressive treatment.Your liver enzymes (AST/ALT) should not be higher than a certain level, unless you have liver metastases or Gilbert's disease.I am not taking blood thinners like warfarin, dabigatran, betrixaban, or clopidogrel.My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.I agree to use effective birth control during the study due to the risk of birth defects from the treatment.I am on low-dose aspirin or certain blood thinners without major bleeding issues.I am 18 years old or older.My tumor responded to the first round of platinum-based chemotherapy.I am fully active or can carry out light work.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I haven't had major surgery in the last 4 weeks and my surgical wounds have healed without ongoing complications.I've had 4-6 rounds of specific chemotherapy as my first treatment.Your absolute neutrophil count is at least 1,000 per cubic millimeter.I received my last chemotherapy 3 to 10 weeks ago.I am a woman who can have children and have a recent negative pregnancy test.Your bilirubin level in the blood is not higher than 1.5 times the upper limit of normal.My cancer originates from the urinary system and is not small-cell type.I am not pregnant or breastfeeding.I haven't had specific immune treatments for cancer.I haven't had significant bleeding or coughed up blood in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (avelumab, cabozantinib)
- Group 2: Arm A (avelumab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Cabozantinib S-malate received regulatory approval from the FDA?
"There is some evidence of efficacy and rounds of safety data supporting Cabozantinib S-malate, so it received a score of 3."
Answered by AI
Are we still receiving volunteers for this experiment?
"Yes, this trial is ongoing and presently recruiting patients. The listing was first posted on March 10th, 2022 and was last updated on November 2nd, 2022."
Answered by AI
How many locations are currently conducting this experiment?
"There are 100 sites presently running this clinical trial, with locations in Princeton, Richmond, Sheboygan, and many other places. To minimize travel for participants, it is important to select the site closest to you."
Answered by AI
What is the primary therapeutic indication of Cabozantinib S-malate?
"Cabozantinib S-malate is commonly used to treat patients who have previously been treated with anti-vegf medication. It can also be used to to manage high risk patients, those with advance directives, and those suffering from renal cell carcinoma."
Answered by AI
Are there any similar trials that have utilized Cabozantinib S-malate?
"In 2012, cabozantinib S-malate was first trialled at Memorial Sloan Kettering Westchester. There are now a total of 328 completed studies, with 232 ongoing investigations, many of which are based in Princeton, Illinois."
Answered by AI
Have there been other scientific research projects like this one in the past?
"There are 232 ongoing clinical trials for Cabozantinib S-malate in 56 different countries and 1720 cities. The first trial began in 2012 and, after completing Phase 2 drug approval, involved 86 patients. As of now, 328 trials have been completed."
Answered by AI
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