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Monoclonal Antibodies
Pembrolizumab + XL888 for Advanced Gastrointestinal Cancer
Phase 1
Waitlist Available
Led By Bassel El-Rayes, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after cycle 1, day 1. each cycle is 21 days
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of XL888 when given with pembrolizumab to treat patients with advanced gastrointestinal cancer. XL888 may stop tumor growth by blocking enzymes needed for cell growth. Pembrolizumab may block tumor growth by targeting certain cells. Giving XL888 with pembrolizumab may work better to treat patients with gastrointestinal cancer.
Eligible Conditions
- Pancreatic Cancer
- Colorectal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after cycle 1, day 1. each cycle is 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after cycle 1, day 1. each cycle is 21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose of the combination of XL888 and pembrolizumab as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Overall response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Overall survival
Progression free survival
+1 moreOther outcome measures
Immune profile effects of pembrolizumab and Hsp90 inhibitor XL888 assessed in serum and tumor biopsies
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, XL888)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and XL888 PO on days 1, 4, 8, 11, 15, and 18. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XL888
2017
Completed Phase 1
~70
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,314 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,235 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,485 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of lung inflammation that is not caused by an infection.You have a condition that weakens your immune system, or you are taking medications that lower your immune system's ability to fight off infections.You have a current case of tuberculosis.You are allergic to pembrolizumab or have had strong allergic reactions to certain ingredients in medications.Your kidney function should be checked according to the hospital's rules.You have had a heart attack or unstable chest pain within the past 6 months, or you have serious heart failure or irregular heartbeats that need medication.You have a current infection that needs medication to treat it.You have received a specific type of cancer medication within the last 4 weeks and have not fully recovered from any side effects.You have received chemotherapy, targeted small molecule therapy, or radiation therapy within the last 2 weeks or have not fully recovered from side effects of previous treatments.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin cancer or early stage cervical cancer.You have cancer that has spread to the brain, except if it has been treated and has not gotten worse for at least four weeks.You have an autoimmune disease that needed strong medicine within the last 2 years.You have a history of drug or alcohol abuse that may make it hard for you to follow the trial's rules.You have been treated with a specific type of medication that targets the immune system.You have been diagnosed with human immunodeficiency virus (HIV).You have ongoing hepatitis B or C infection.You have advanced gastrointestinal cancers that cannot be removed by surgery, and you have already tried at least one treatment.You have pancreatic cancer that cannot be removed by surgery or has spread, and you have already tried one standard treatment. If you are in the dose escalation phase (arm A), you need to be willing to have a biopsy and give permission for it.You have colorectal cancer that cannot be removed by surgery or has spread, and you have already been treated with specific chemotherapy drugs. Additionally, you must be willing to have a biopsy of your tumor and agree to participate in the study.You have a tumor that can be measured according to specific guidelines.You have enough infection-fighting white blood cells.You need to have at least 100,000 platelets per microliter of blood.Your hemoglobin level is at least 9 g/dL without needing a blood transfusion or EPO within the last 7 days.Your albumin levels in the blood are 2.5 mg/dL or higher.Your kidney function is good, and your blood creatinine levels are within a normal range.Your bilirubin levels in the blood are within a certain range.Your AST and ALT levels in your blood are not too high, unless you have cancer that has spread to the liver, in which case they can be a little higher.Your blood clotting time is not too fast or too slow, unless you are already on medication that affects clotting.Your blood clotting time is not too fast unless you are already taking medication to slow it down and it is within the right range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, XL888)
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.
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