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Tyrosine Kinase Inhibitor
Cabozantinib + Pembrolizumab for Bladder Cancer (PemCab Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Be greater to or equal to 18 years of age on day of signing informed consent
- Performance Status ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients are expected to stay on treatment for approximately 12 months; 18 months
Awards & highlights
PemCab Trial Summary
This trial is testing a combination of two drugs to treat people with urothelial carcinoma who can't take cisplatin. They'll look at how well the drugs work, how long people live, and if there are any side effects.
Who is the study for?
Adults with advanced urothelial carcinoma who can't have cisplatin. They need a certain level of physical fitness (ECOG 0-2), adequate organ function, and no recent significant illnesses or treatments that could affect their participation. Participants must not be pregnant, agree to use effective contraception, and have recovered from any previous therapies' side effects.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Pembrolizumab and Cabozantinib in patients with metastatic urothelial carcinoma ineligible for cisplatin. It's an open-label phase 2 study focusing on how well tumors respond to treatment, how long patients live without disease progression at six months, and overall survival rates.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, hand-foot syndrome (redness and pain in hands/feet), mouth sores, loss of appetite, diarrhea or constipation. There may also be risks related to immune system reactions like inflammation in organs.
PemCab Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My kidney function, measured by creatinine clearance, is low but not extremely poor.
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I have chosen not to participate in certain treatments.
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My cancer is confirmed to be urothelial carcinoma.
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I am eligible for a bladder tissue biopsy.
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I cannot receive any platinum-based chemotherapy treatments.
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My cancer has spread beyond its original site and cannot be surgically removed.
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I need some help with my daily activities.
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My nerve damage is mild or I don't have any.
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I have hearing loss.
PemCab Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients are expected to stay on treatment for approximately 12 months; 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients are expected to stay on treatment for approximately 12 months; 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Occurrence of Adverse Events and Serious Adverse Events
Overall Survival (OS)
Progression-free survival (PFS) at 6 months (PFS6)
PemCab Trial Design
1Treatment groups
Experimental Treatment
Group I: Cabozantinib and Pembrolizumab, all patientsExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cabozantinib
2020
Completed Phase 2
~1760
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway, which cancer cells use to evade immune detection. Cabozantinib, a tyrosine kinase inhibitor, targets multiple pathways involved in tumor growth and blood vessel formation, thereby inhibiting tumor proliferation and reducing its blood supply.
These mechanisms are significant for bladder cancer patients as they offer targeted approaches to control disease progression and improve survival rates.
[The role of immunotherapy in the modern treatment of urothelial carcinoma].
[The role of immunotherapy in the modern treatment of urothelial carcinoma].
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Who is running the clinical trial?
University of UtahLead Sponsor
1,104 Previous Clinical Trials
1,782,499 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,498 Total Patients Enrolled
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