Cabozantinib S-malate for Urethral Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Urethral Cancer+21 MoreCabozantinib S-malate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding cabozantinib to avelumab improves treatment of metastatic urothelial cancer.

Eligible Conditions
  • Stage III Urethral Cancer
  • Stage IV Bladder Cancer
  • Urothelial Carcinoma of the Ureter
  • Urethral Cancer
  • Stage III Renal Pelvis Cancer
  • Stage IV Renal Pelvis and Ureter Cancer
  • Bladder Cancer
  • Urethral Urothelial Carcinoma
  • Stage III Renal Pelvis and Ureter Cancer
  • Stage IV Renal Pelvis Cancer
  • Stage III Bladder Cancer
  • Stage IVA Bladder Cancer
  • Urothelial Carcinoma of the Renal Pelvis
  • Stage IIIA Bladder Cancer
  • Stage III Ureter Cancer
  • Stage IV Ureter Cancer
  • Stage IIIB Bladder Cancer
  • Stage IVB Bladder Cancer
  • Stage IV Urethral Cancer
  • Metastatic Urothelial Carcinoma of the Renal Pelvis
  • Metastatic Urothelial Carcinoma of the Ureter

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival (OS)
Year 5
Progression free survival (PFS)
Up to 5 years
Incidence of adverse events (AE)
Tumor response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Cabozantinib
85%Fatigue
77%Nausea
62%Dysgeusia
62%Vomiting
54%Mucositis Oral
54%Aspartate Aminotransferase Increased
54%Abdominal Pain
54%Alkaline Phosphatase Increased
46%Anorexia
46%Hypertension
38%Weight Loss
38%Alanine Aminotransferase Increased
38%Anemia
38%Diarrhea
38%Constipation
38%Cough
38%Thromboembolic Event
38%Dyspnea
31%Back Pain
31%Hypomagnesemia
31%Lipase Increased
31%Hypoalbuminemia
23%Palmar-Plantar Erythrodysesthesia Syndrome
23%Pain
23%Hypophosphatemia
23%Alopecia
23%Hypothyroidism
23%Oral Pain
23%Hyperglycemia
23%Dizziness
23%Pain In Extremity
23%Headache
15%Platelet Count Decreased
15%Insomnia
15%Sore Throat
15%Abdominal Distension
15%Activated Partial Thromboplastin Time Prolonged
15%White Blood Cell Decreased
15%Myalgia
15%Dry Mouth
15%Dyspepsia
15%Bloating
15%Dehydration
15%Hypocalcemia
15%Dry Skin
15%Flushing
15%Peripheral Sensory Neuropathy
8%Bruising
8%Hyponatremia
8%Flank Pain
8%Syncope
8%Proteinuria
8%Pleural Effusion
8%Nasal Congestion
8%Pleuritic Pain
8%Hoarseness
8%Nail Discoloration
8%Weight Gain
8%Ventricular Tachycardia
8%Pancreatitis
8%Upper Respiratory Infection
8%Creatinine Increased
8%Neutrophil Count Decreased
8%Arthralgia
8%Bone Pain
8%Tinnitus
8%Gastrointestinal Pain
8%Floaters
8%Gastroesophageal Reflux Disease
8%Chest Pain - Cardiac
8%Vertigo
8%Dysphagia
8%Blood Bilirubin Increased
8%Lung Infection
8%Fever
8%Depression
8%Hypersomnia
8%Generalized Muscle Weakness
8%Skin Induration
8%Hypotension
8%Productive Cough
8%Memory Impairment
8%Anxiety
8%Cardiac Troponin I Increased
8%Urinary Incontinence
8%Allergic Rhinitis
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02315430) in the Cabozantinib ARM group. Side effects include: Fatigue with 85%, Nausea with 77%, Dysgeusia with 62%, Vomiting with 62%, Mucositis Oral with 54%.

Trial Design

2 Treatment Groups

Arm A (avelumab)
1 of 2
Arm B (avelumab, cabozantinib)
1 of 2

Active Control

Experimental Treatment

654 Total Participants · 2 Treatment Groups

Primary Treatment: Cabozantinib S-malate · No Placebo Group · Phase 3

Arm B (avelumab, cabozantinib)Experimental Group · 4 Interventions: Avelumab, Quality-of-Life Assessment, Cabozantinib S-malate, Questionnaire Administration · Intervention Types: Drug, Other, Drug, Other
Arm A (avelumab)ActiveComparator Group · 3 Interventions: Avelumab, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,085 Previous Clinical Trials
41,140,817 Total Patients Enrolled
20 Trials studying Urethral Cancer
2,080 Patients Enrolled for Urethral Cancer
Shilpa GuptaPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
1 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant or adjuvant chemotherapy will be allowed if given 12 or more months prior to registration).
The last dose of first-line chemotherapy must have been received no less than 3 weeks, and no more than 10 weeks, prior to randomization in the present study.
You have a performance status of 0 or 1.
You are of childbearing potential and have not had a pregnancy in the last 14 days.
You have received at least one course of platinum-based chemotherapy for ovarian cancer by a physician.
You have not received any immunotherapy for cancer, or any immunotherapy specifically targeting T-cell co-stimulation or immune checkpoint pathways.