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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
Patients with known MSI-High or dMMR tumors must have disease progression after at least one line of immunotherapy
Locally advanced, recurrent, or metastatic disease not amenable to curative intent surgery
Must not have
Known history of HIV infection
History of allergic reactions to pembrolizumab, cabozantinib or other agents used in study
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
No Placebo-Only Group
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.
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.
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 belowSelect...
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 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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with HIV.
Select...
I have no allergies to pembrolizumab, cabozantinib, or similar medications.
Select...
I do not have any uncontrolled illnesses.
Select...
I have an active case of tuberculosis.
Select...
I am currently taking blood thinners.
Select...
I am currently on medication for an infection.
Select...
I haven't had chemotherapy in the last 2 weeks.
Select...
My cancer is a type of stomach cancer called squamous cell or undifferentiated.
Select...
Side effects from my previous cancer treatment, except for hair loss, have not improved to mild or returned to normal.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I haven't had major surgery in the last 2 weeks or minor surgery in the last 10 days.
Select...
I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.
Select...
I have been treated with cabozantinib before.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants with Progression-free Survival at 6 Months
Secondary study objectives
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 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~3130
Cabozantinib
2020
Completed Phase 2
~2360
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,933,028 Total Patients Enrolled
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,138 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.You are currently pregnant or breastfeeding.I have no allergies to pembrolizumab, cabozantinib, or similar medications.I do not have any uncontrolled illnesses.I have not received a live vaccine in the last 30 days.I have an active case of tuberculosis.I am currently taking blood thinners.I am currently on medication for an infection.I have not had another type of cancer in the past 3 years.I have had one treatment with a checkpoint inhibitor and my cancer progressed, or my PD-L1 score is below 10%.I can swallow pills.I haven't had chemotherapy in the last 2 weeks.I don't have any health issues that could affect the study's results or my participation.My MSI-High or dMMR tumor has worsened after immunotherapy.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.My cancer cannot be removed by surgery.You are expected to live for at least 3 more months.I can take care of myself but might not be able to do heavy physical work.I have recently undergone radiation therapy.My cancer is confirmed as gastric or gastroesophageal adenocarcinoma.My cancer is a type of stomach cancer called squamous cell or undifferentiated.Your platelet count needs to be at least 60,000 per microliter of blood.My cancer did not respond or I couldn't tolerate a treatment that included platinum or fluoropyrimidine.Side effects from my previous cancer treatment, except for hair loss, have not improved to mild or returned to normal.I haven't had cancer treatment in the last 2 weeks.I haven't taken any small molecule kinase inhibitors in the last 2 weeks.My brain metastases have been stable and untreated for at least 4 weeks.You need to have at least 1000 neutrophils per microliter of blood.I can take care of myself but might not be able to do heavy physical work.I have had pneumonitis treated with steroids or have it now.I am 18 years old or older.My cancer is confirmed to be gastric or gastroesophageal adenocarcinoma.My cancer progressed after one treatment with a checkpoint inhibitor.My organs and bone marrow are working well.I haven't had major surgery in the last 2 weeks or minor surgery in the last 10 days.You have a sufficient amount of white blood cells in your body, at least 2,000 per microliter.You cannot be taking any other experimental drugs.I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.My cancer cannot be removed by surgery.I have been treated with cabozantinib before.You have an autoimmune disease that required treatment in the past two years.You have a medical condition that could make it unsafe for you to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib and Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.