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New treatment option for Biliary Tract Cancer
Official title A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
ClinicalTrials.gov ID: NCT07221253
What this study is testing
What is Rilvegostomig?
Rilvegostomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract cancer.
Also referred to as AZD2936.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder...
- Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
- Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
- Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
- ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS \> 1) over the previous 2 weeks prior to baseline at screening and prior to...
You likely can't join if
- Ampullary carcinoma
- Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
- Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
- Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under...
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or...
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
- Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
- Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
- Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
- ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS \> 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.
- Adequate bone marrow and organ function. Key
- Ampullary carcinoma
- Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
- Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
- Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Duarte, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
+ 134 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; Orange, California, United States; Palo Alto, California, United States and 148 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.