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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

Pivotal Trial

No Placebo-Only Group

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.

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.

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

Secondary study objectives

Incidence of adverse events (AE)

Progression free survival (PFS)

Tumor response

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02315430

85%

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%

Sore Throat

15%

Activated Partial Thromboplastin Time Prolonged

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

Allergic Rhinitis

Generalized Muscle Weakness

Creatinine Increased

Hyponatremia

Flank Pain

Bone Pain

Gastroesophageal Reflux Disease

Chest Pain - Cardiac

Vertigo

Neutrophil Count Decreased

Arthralgia

Syncope

Proteinuria

Pleural Effusion

Nasal Congestion

Pleuritic Pain

Hoarseness

Nail Discoloration

Ventricular Tachycardia

Tinnitus

Gastrointestinal Pain

Floaters

Dysphagia

Blood Bilirubin Increased

Lung Infection

Fever

Depression

Hypersomnia

Hypotension

Productive Cough

Memory Impairment

Anxiety

Cardiac Troponin I Increased

Urinary Incontinence

Pancreatitis

Upper Respiratory Infection

Bruising

Weight Gain

Skin Induration

100%

80%

60%

40%

20%

Study treatment Arm

Cabozantinib

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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. Patients may undergo urine sample collection as clinically indicated.

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. Patients may undergo urine sample collection as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Bone Scan

2015

Completed Phase 2

~50