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Chemotherapy
CDX-1140 + CAPOX + Keytruda for Bile Duct Cancer
Phase 1 & 2
Recruiting
Led By Maria C Monge Bonilla, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 study start - 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combo of drugs to treat advanced biliary tract cancer, aiming to improve PFS and response rate.
Who is the study for?
Adults over 18 with advanced Biliary Tract Carcinoma (BTC) that's worsened after treatment and can't be removed by surgery or improved with a liver transplant. They must have acceptable organ function, no recent major surgeries, not be pregnant, and agree to use contraception. People who've had certain vaccines recently, those with HIV or active CNS metastases, or a history of severe allergies to similar drugs are excluded.
What is being tested?
The trial is testing CDX-1140 in combination with Capecitabine (a pill), Oxaliplatin (intravenous), and Keytruda (intravenous) for BTC treatment. Participants will undergo cycles of these treatments: intravenous on days 1 and 8 for the first six cycles then day 1 only afterward; pills taken twice daily for two weeks each cycle but stopped after six cycles.
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, digestive issues like nausea or diarrhea from capecitabine and oxaliplatin; immune-related effects such as inflammation in organs from Keytruda; blood count changes could occur due to all drugs involved.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study start - 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study start - 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase I: Safe dose of CDX-1140 in combination with CAPOX and Keytruda(R)
Phase II: 6-month progression free survival (PFS) probability
Phase II: Overall response rate (ORR)
Secondary study objectives
5-year overall survival
Safety of CDX-1140, CAPOX and Keytruda(R) in participants with advanced BTC as determined by toxicities experienced
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase IIExperimental Treatment4 Interventions
Keytruda, oxaliplatin, capecitabine and estimated safe dose of CDX-1140
Group II: Phase IExperimental Treatment4 Interventions
Keytruda, oxaliplatin, capecitabine and escalating doses of CDX-1140
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
oxaliplatin
2002
Completed Phase 3
~6370
capecitabine
2002
Completed Phase 3
~2360
CDX-1140
2017
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,393 Total Patients Enrolled
5 Trials studying Biliary Cancers
448 Patients Enrolled for Biliary Cancers
Maria C Monge Bonilla, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term steroids or other drugs that weaken my immune system.My organs and bone marrow are functioning well.I haven't had cancer treatment in the last 4 weeks.I have previously been treated with anti-CD40 therapy.I have not received any live vaccines in the last 30 days.I have had or currently have lung inflammation not caused by an infection.I have not had any other cancers in the last 3 years.I had side effects from previous immune therapy that I couldn't handle.My largest tumor or metastasis is 8 cm or smaller.I have cancer that has spread to my brain or the membranes around my brain and spinal cord.I am breastfeeding but willing to stop during the study.My cancer has been confirmed as bile duct cancer through a tissue examination.My hepatitis C is under control with undetectable virus levels.My condition cannot be cured with surgery or liver transplant.I am fully active or can carry out light work.I am 18 years old or older.I have recovered from side effects of my previous treatment.I have hepatitis B, am on antivirals, and my HBV DNA is under 100 IU/mL.My heart's electrical activity (QTcF) is normal and I'm not at risk for irregular heartbeats.I agree to use effective birth control during the study.I have not had major surgery in the last 4 weeks.My condition worsened after the first standard treatment or I refused it.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I
- Group 2: Phase II
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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