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Taxane
Durvalumab + Chemotherapy for Biliary Tract Cancer (TOURMALINE Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
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 from the date of the first dose of imp until death due to any cause [approx. upto 33 months]
Awards & highlights
TOURMALINE Trial Summary
This trial studies a drug combo to see if it's safe and effective for people with a type of tumor.
Who is the study for?
This trial is for adults over 30 kg with advanced biliary tract cancers, including cholangiocarcinoma, gallbladder carcinoma, and ampulla of Vater carcinoma. They should be able to perform daily activities (ECOG PS 0-2) and have at least one measurable tumor. Women must not be pregnant and all participants must use contraception. People with brain metastases, active infections like HIV or hepatitis, severe diseases, recent major surgeries or certain cancer treatments can't join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of durvalumab combined with various gemcitabine-based chemotherapy regimens in patients with advanced biliary tract cancers. Durvalumab is an immunotherapy drug given alongside standard chemotherapies like cisplatin or oxaliplatin to see if it improves outcomes.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues; plus typical chemotherapy side effects including nausea, fatigue, low blood cell counts leading to increased infection risk.
TOURMALINE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of the first dose of imp until death due to any cause [approx. upto 33 months]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of the first dose of imp until death due to any cause [approx. upto 33 months]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Grade 3 or 4 possibly related adverse event (PRAE)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Duration of Treatment (DOT)
+7 moreTOURMALINE Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab + Gemcitabine based chemotherapyExperimental Treatment8 Interventions
Participants will receive durvalumab 1500mg every 3 or 4 weeks, in combination with continuation of all or some of the original background gemcitabine based chemotherapy every 3 or 2 weeks for up to a maximum of 8 cycles of chemotherapy. Durvalumab 1500mg is given as a 60-minute IV infusion in the first cycle (Day 1) and as a 30-minute IV infusion in following cycles.
Upon completing 8 cycles of background gemcitabine-chemotherapy, or after discontinuing any of the combination chemotherapies due to toxicity before completing 8 cycles, participants are eligible to continue receiving durvalumab 1500 mg IV every 4 weeks either alone or in combination with gemcitabine-based chemotherapy (with the exception of paclitaxel), as per investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,535 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer spread to the lining of my brain and spinal cord.I do not have severe illnesses like uncontrolled high blood pressure, active infections, or serious heart conditions.I had cancer before, but it was treated successfully over 5 years ago.I can take care of myself and am up and about more than 50% of my waking hours.I have not received a live vaccine in the last 30 days.My partner and I are using birth control or are surgically sterile.I received my last cancer treatment less than 28 days ago.I have tested positive for HIV or have active tuberculosis.I have both Hepatitis B and either Hepatitis C or D.I have lasting side effects from cancer treatment that are moderate or worse.I have brain metastases needing treatment or a history of spinal cord compression.I have been treated with immunotherapy, but not cancer vaccines.I am not on any cancer treatments other than what this study allows.I have at least one tumor that can be measured for treatment response.I have not had major surgery in the last 28 days.My organs and bone marrow are working well.My bile duct cancer cannot be removed by surgery or has spread.I am a woman who has not had a menstrual period for at least 12 months without other medical reasons.I have had recent radiotherapy but not over 30% of my bone marrow.My cancer is a type of biliary tract cancer that cannot be surgically removed.My body weight is more than 30 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + Gemcitabine based chemotherapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Does this research encompass individuals of any age, including those under 30?
"This trial is seeking individuals who meet the criteria of being above 18 and below 130 years old."
Answered by AI
How many centers are overseeing this clinical trial?
"30 clinical trial sites are available for patient enrollment, located in Washington, Portland, Clichy and other cities. To reduce the burden of travel costs, it is beneficial to choose the closest location when enrolling in this study."
Answered by AI
Are there any vacancies for prospective participants in this research endeavor?
"Per the information on clinicaltrials.gov, this experiment is not presently signing up participants. The trial was first listed on 30th July 2023 and its last update occurred 6th March 2023. Although it is not possible to take part in this study currently, there are 102 other trials that are open to applicants."
Answered by AI
To what extent is Durvalumab + Gemcitabine chemotherapy hazardous to human health?
"There is substantial clinical data indicating the safety of durvalumab and gemcitabine, which has earned it a 3 on our team's scale."
Answered by AI
Who meets the criteria for participating in this experiment?
"This clinical trial seeks to recruit around 160 individuals that have been diagnosed with biliary tract cancer and are of age 18 or older, but no older than 130."
Answered by AI
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