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Tyrosine Kinase Inhibitor
Cabozantinib + Durvalumab +/- Tremelimumab for Gastrointestinal Cancers (CAMILLA Trial)
Phase 1 & 2
Waitlist Available
Led By Anwaar Saeed, MD
Research Sponsored by Raed Al-Rajabi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
Body weight > 66 lbs (30 kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks for 12 months
Awards & highlights
CAMILLA Trial Summary
This trial is testing the safety of combining two drugs to treat gastroesophageal cancer and other gastrointestinal cancers. The goal is to find a more effective therapy for these patients.
Who is the study for?
Adults over 18 with certain advanced gastrointestinal cancers, including stomach and liver cancer, who have progressed after standard treatments or are intolerant to them. Participants must be able to swallow tablets, not have major organ dysfunction, agree to contraception if of childbearing potential, and not have a history of severe allergies or reactions to the study drugs.Check my eligibility
What is being tested?
The trial is testing the combination of Cabozantinib (a drug that targets tumor environment) with Durvalumab (an immunotherapy), plus or minus Tremelimumab (another immunotherapy). It's an early-phase trial assessing safety and how well these drugs work together in treating gastroesophageal and other GI cancers.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding risks like nosebleeds or coughing up blood, immune-related issues such as inflammation in organs like the lungs or intestines, fatigue, skin reactions from rash to itching, liver function changes, and increased risk of infections.
CAMILLA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as stomach or gastroesophageal junction cancer.
Select...
I weigh more than 66 lbs (30 kg).
Select...
I am 18 years old or older.
Select...
My cancer is at an advanced stage and cannot be removed by surgery.
Select...
My stomach or esophagus cancer has worsened or didn't respond well to previous treatments.
Select...
I am post-menopausal or have a negative pregnancy test if pre-menopausal.
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I am fully active or can carry out light work.
Select...
My diagnosis is colorectal cancer.
Select...
My diagnosis is esophageal adenocarcinoma.
Select...
My diagnosis of liver cancer is confirmed through tissue examination.
CAMILLA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks for 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks for 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I- Maximum Tolerated Dose (MTD)
Phase II- Overall Response Rate (ORR)
Secondary outcome measures
Overall Benefit Rate (OBR)
Overall Survival (OS)
Progression Free Survival (PFS)
+1 moreCAMILLA Trial Design
4Treatment groups
Experimental Treatment
Group I: Cabozantinib plus Durvalumab plus Tremelimumab (Hepatocellular carcinoma cohort)Experimental Treatment3 Interventions
Cabozantinib
By mouth (PO) once daily on days 1-28 of every 28 day cycle
Dose will be 40mg
Durvalumab *Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
Tremelimumab
*Single dose of 300mg intavenous (IV) infusion on day 1 of cycle 1
Group II: Cabozantinib plus Durvalumab (Hepatocellular carcinoma cohort)Experimental Treatment2 Interventions
Cabozantinib
By mouth (PO) once daily on days 1-28 of every 28 day cycle
Dose will be 40mg
Durvalumab
*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
Group III: Cabozantinib plus Durvalumab (Gastric & esophageal cancer cohort)Experimental Treatment2 Interventions
Cabozantinib
By mouth (PO) once daily on days 1-28 of every 28 day cycle
Dose will be 40mg
Durvalumab
*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
Group IV: Cabozantinib plus Durvalumab (Colorectal cancer cohort)Experimental Treatment2 Interventions
Cabozantinib
By mouth (PO) once daily on days 1-28 of every 28 day cycle
Dose will be 40mg
Durvalumab
*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
Raed Al-RajabiLead Sponsor
Anwaar SaeedLead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,274 Previous Clinical Trials
288,613,247 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any major abdominal issues like fistulas or obstructions in the last 6 months.My cancer has spread to my digestive system.My stomach or esophagus veins are treated and stable for 6 months.I do not have active stomach or bowel issues like ulcers, Crohn's, or pancreatitis.I have not had signs of lung bleeding in the last 3 months.I have brain metastases or cancer in the lining of my brain that hasn't been treated.I agree to use effective birth control during and for 6 months after the study.My cancer is confirmed as stomach or gastroesophageal junction cancer.I weigh more than 66 lbs (30 kg).I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.I haven't taken strong immune-weakening medicines in the last 2 weeks, except for common corticosteroids.I have or had an autoimmune or inflammatory disorder.I do not have active infections like TB, hepatitis B or C, or HIV, except for allowed cases in HCC patients.I have not received a live vaccine in the last 30 days.My blood pressure is high even with treatment.I had cancer before, but it was treated, and there's no sign of it now.I had skin cancer (not melanoma) treated and currently show no signs of it.My early-stage cancer was treated successfully with no signs of disease.My cancer's MSI or MMR status is known, or will be tested.I have been treated with PD1, PD-L1, or PD-L2 inhibitors before.My stomach or esophagus cancer has worsened or didn't respond well to previous treatments.My colorectal cancer has worsened or not responded to at least 2 treatments, and I've tried an EGFR antibody.I have recovered from previous treatment side effects, or they are minor and stable.I have lung lesions or disease in my airways.I haven't had major surgery, like GI surgery or brain surgery, in the last 8 weeks.I have received an organ transplant from another person.I am on certain blood thinners or platelet inhibitors, but not for brain metastases or significant bleeding issues.I am 18 years old or older.I haven't had a stroke, heart attack, or blood clot in the last 6 months, or if I had a clot, it's been treated and stable for 2 weeks.My cancer is at an advanced stage and cannot be removed by surgery.I have fluid buildup that can't be controlled with treatment.I am post-menopausal or have a negative pregnancy test if pre-menopausal.You have serious health conditions that would make it unsafe for you to participate in the study.My organs and bone marrow are working well.My liver cancer is affecting major blood vessels, but I am still eligible.I have not taken cancer drugs like cabozantinib or crizotinib before.You have a history of a weak immune system that makes it hard for your body to fight off infections.I have no lasting side effects from cancer treatment worse than Grade 2.I am fully active or can carry out light work.My diagnosis is colorectal cancer.I cannot swallow pills.My diagnosis is esophageal adenocarcinoma.My diagnosis of liver cancer is confirmed through tissue examination.I have not had significant bleeding in the last 3 months.I have liver cancer and either haven't been treated or my cancer got worse or I couldn't tolerate my first treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib plus Durvalumab (Gastric & esophageal cancer cohort)
- Group 2: Cabozantinib plus Durvalumab (Hepatocellular carcinoma cohort)
- Group 3: Cabozantinib plus Durvalumab plus Tremelimumab (Hepatocellular carcinoma cohort)
- Group 4: Cabozantinib plus Durvalumab (Colorectal cancer cohort)
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.
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 common conditions that doctors use Durvalumab to manage?
"The therapeutic benefits of Durvalumab have been observed in patients with a pre-existing condition, those who have received anti-vegf treatments, and those who supplement their amino acids."
Answered by AI
Does this program still have room for more participants?
"That is accurate. The clinical trial in question, which can be found on clinicaltrials.gov, is seeking patients at the moment. This specific study was posted on October 22nd, 2018 and updated as recently as May 8th, 2022. There is a total goal of 117 patients across 1 location."
Answered by AI
What other research exists on this topic?
"AstraZeneca first began sponsoring research into Durvalumab in 2007. That year, the drug underwent its first clinical trial. After Phase 2 approval was granted in 2007, following a 37 person study, today there are 501 active trials involving Durvalumab being conducted across 2003 cities and 60 countries."
Answered by AI
What is the extensive history of Durvalumab in previous medical research?
"501 clinical trials are being conducted for Durvalumab globally. Out of these, 67 are in Phase 3. Port Huron, Michigan is the city with the most studies, however there are 26413 locations running at least one trial for this medication."
Answered by AI
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