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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)

Must not have

Evidence of tumor invading the GI tract (Defined as T4 primary tumor in patients with gastric, gastroesophageal and esophageal adenocarcinoma and CRC)

Evidence of active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks for 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as stomach or gastroesophageal junction cancer.

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I weigh more than 66 lbs (30 kg).

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I am 18 years old or older.

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My cancer is at an advanced stage and cannot be removed by surgery.

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My stomach or esophagus cancer has worsened or didn't respond well to previous treatments.

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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.

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My diagnosis is colorectal cancer.

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My diagnosis is esophageal adenocarcinoma.

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My diagnosis of liver cancer is confirmed through tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my digestive system.

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I do not have active stomach or bowel issues like ulcers, Crohn's, or pancreatitis.

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I have not had signs of lung bleeding in the last 3 months.

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I have brain metastases or cancer in the lining of my brain that hasn't been treated.

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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.

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I have or had an autoimmune or inflammatory disorder.

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My blood pressure is high even with treatment.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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My early-stage cancer was treated successfully with no signs of disease.

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I have lung lesions or disease in my airways.

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I haven't had major surgery, like GI surgery or brain surgery, in the last 8 weeks.

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I have received an organ transplant from another person.

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I have fluid buildup that can't be controlled with treatment.

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I have not taken cancer drugs like cabozantinib or crizotinib before.

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I have no lasting side effects from cancer treatment worse than Grade 2.

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I cannot swallow pills.

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I have not had significant bleeding in the last 3 months.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks for 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I- Maximum Tolerated Dose (MTD)

Phase II- Overall Response Rate (ORR)

Secondary study objectives

Overall Benefit Rate (OBR)

Overall Survival (OS)

Progression Free Survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2360

Durvalumab

2017

Completed Phase 2

~3750