← Back to Search

Tyrosine Kinase Inhibitor

Cabozantinib + Pembrolizumab for Stomach Cancer

Phase 2
Waitlist Available
Led By Farshid Dayyani, MD, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have progressed, or not tolerated, at least one line of treatment with a platinum and/or fluoropyrimidine containing regimen. At least one cycle of combination chemotherapy including a platinum (oxaliplatin, cisplatin, carboplatin) and/or fluoropyrimidine (capecitabine or 5-Fluorouracil) based regimen for advanced disease. Combination regimens with platinum/fluoropyrimidine containing a taxane and or a checkpoint inhibitor are allowed. Patients progressing within six months of perioperative chemotherapy or definitive chemoradiation for localized disease are eligible. Patients who have exhausted all other standard of care options are also eligible.
Must have received and progressed on one previous line of treatment containing a checkpoint inhibitor (if PD-L1 Combined Positive Score (CPS) score unknown or ≥ 10%). Patients with PD-L1 CPS score < 10% are eligible independent of whether they have received previous checkpoint inhibitors.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Awards & highlights

Study Summary

This trial is testing a new cancer drug combo to see if it's effective for people with stomach or throat cancer who haven't responded to other treatments.

Who is the study for?
Adults with advanced gastric or gastroesophageal adenocarcinoma who've had at least one prior chemotherapy but didn't respond well or couldn't tolerate it. They must have tried a checkpoint inhibitor if their PD-L1 score is high enough, be in fairly good health, and not planning to get pregnant. People can't join if they're very sick with other illnesses, recently had certain treatments or surgeries, are allergic to the drugs being tested, have HIV/TB/active infections, or are on strong immune system drugs.Check my eligibility
What is being tested?
This trial tests cabozantinib combined with pembrolizumab in patients whose stomach cancer has spread and isn't responding to standard treatments. It's an open-label study where everyone gets both drugs to see how effective this combo is after previous therapies failed.See study design
What are the potential side effects?
Cabozantinib might cause diarrhea, mouth sores, hand-foot syndrome (redness and pain on palms/soles), high blood pressure and tiredness. Pembrolizumab could lead to immune-related side effects like inflammation of organs (lungs, intestines), skin rash and potential infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had at least one treatment for my cancer that didn't work or I couldn't tolerate, including drugs like platinum or fluoropyrimidine.
Select...
I have had one treatment with a checkpoint inhibitor and my cancer progressed, or my PD-L1 score is below 10%.
Select...
My MSI-High or dMMR tumor has worsened after immunotherapy.
Select...
My cancer cannot be removed by surgery.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer is confirmed as gastric or gastroesophageal adenocarcinoma.
Select...
My cancer did not respond or I couldn't tolerate a treatment that included platinum or fluoropyrimidine.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
My cancer is confirmed to be gastric or gastroesophageal adenocarcinoma.
Select...
My cancer progressed after one treatment with a checkpoint inhibitor.
Select...
My cancer cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Progression-free Survival at 6 Months
Secondary outcome measures
Overall Response Rate as Assessed by RECIST v1.1
Overall Survival of Patients Who Received Cabozantinib and Irinotecan
Percentage of Grade 3-5 Adverse Events

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cabozantinib and PembrolizumabExperimental Treatment2 Interventions
Subjects receive Cabozantinib 40mg PO daily on days 1-21 and Pembrolizumab 200mg IV on day 1 every 21 days.
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 California, IrvineLead Sponsor
536 Previous Clinical Trials
1,921,580 Total Patients Enrolled
ExelixisIndustry Sponsor
116 Previous Clinical Trials
18,066 Total Patients Enrolled
Farshid Dayyani, MD, PhD5.02 ReviewsPrincipal Investigator - Chao Family Comprehensive Cancer Center
University of California, Irvine
3 Previous Clinical Trials
77 Total Patients Enrolled
5Patient Review
Dr. Sayyani has been fantastic in helping me manage the side effects of my chemotherapy. He's always willing to answer my questions and concerns, even if he doesn't have all the answers. I would recommend him to anyone undergoing treatment for cancer.

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04164979 — Phase 2
Gastroesophageal Cancer Research Study Groups: Cabozantinib and Pembrolizumab
Gastroesophageal Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04164979 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04164979 — Phase 2

Frequently Asked Questions

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

If a patient wanted to enroll today, would they be able to?

"The trial is currently active and looking for 20 patients at a single location, this is according to information found on clinicaltrials.gov. The study was first posted on February 4th, 2020 and was last updated on October 31st, 2020."

Answered by AI

How many individuals are signed up to participate in this experiment?

"Yes, according to the information available on clinicaltrials.gov, this study is still recruiting patients. The trial was first posted on February 4th, 2020 and was most recently updated on October 31st, 2022. They are looking for a total of 20 participants at a single location."

Answered by AI

What are some common conditions that Pembrolizumab is used to treat?

"Pembrolizumab is frequently used to treat melanoma that cannot be surgically removed. It is also approved for use in cases of microsatellite instability high and patients with a high risk of recurrence."

Answered by AI

Could you give some historical context for Pembrolizumab's medical usage?

"Presently, there are 1108 clinical trials underway that involve pembrolizumab. Out of these active studies, 135 have reached Phase 3 testing. The majority of pembrolizumab trials are based in Houston, Texas; however, 43129 medical facilities across the globe are running similar tests."

Answered by AI

Has Pembrolizumab been cleared by the FDA?

"While there is some data supporting the safety of Pembrolizumab, it only exists for phase 2 trials. This means that its efficacy has not been studied and thus cannot be vouched for."

Answered by AI
~4 spots leftby Mar 2025