← Back to Search

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 below
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My kidney function, measured by creatinine clearance, is low but not extremely poor.
Select...
I have chosen not to participate in certain treatments.
Select...
My cancer is confirmed to be urothelial carcinoma.
Select...
I am eligible for a bladder tissue biopsy.
Select...
I cannot receive any platinum-based chemotherapy treatments.
Select...
My cancer has spread beyond its original site and cannot be surgically removed.
Select...
I need some help with my daily activities.
Select...
My nerve damage is mild or I don't have any.
Select...
I have hearing loss.

PemCab Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients are expected to stay on treatment for approximately 12 months; 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients are expected to stay on treatment for approximately 12 months; 18 months for reporting.

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
~1950
Cabozantinib
2020
Completed Phase 2
~1080

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,314 Total Patients Enrolled
ExelixisIndustry Sponsor
116 Previous Clinical Trials
18,051 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most recent findings from research on Pembrolizumab?

"City of Hope was the first to study pembrolizumab back in 2010 and there have been 305 completed trials since. Right now, 1108 more studies are recruiting patients with a significant number taking place in Salt Lake City, Utah."

Answered by AI

Pembrolizumab has been linked to several fatalities, is this medication safe for human use?

"Pembrolizumab has received a Phase 2 safety rating, meaning that while there is evidence suggesting it is safe, more data needs to be collected regarding its efficacy."

Answered by AI

What are some of the main reasons that Pembrolizumab is given to patients?

"Pembrolizumab is frequently used to treat unresectable melanoma. However, it can also be helpful for patients with microsatellite instability high, those at a high risk of disease recurrence, and other conditions."

Answered by AI

Are people still being asked to participate in this clinical trial?

"That is correct. As of now, the clinical trial indicated on clinicaltrials.gov is looking for patients to participate. This study was first posted on September 18th, 2018 and has since been updated on June 9th, 2022. A total of 39 patients are needed from 3 different locations."

Answered by AI

How many people are volunteering for this research project?

"Yes, the information on clinicaltrials.gov suggests that this trial is currently searching for patients. The trial was first posted on 9/18/2018 and was last edited on 6/9/2022. The clinical trial is looking for 39 patients between 3 sites"

Answered by AI
~1 spots leftby May 2024