Rilvegostomig or durvalumab with gemcitabine–cisplatin for first-line biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized interventional trial assigns adults with unresectable locally advanced or metastatic biliary tract adenocarcinoma to receive either rilvegostomig plus gemcitabine and cisplatin or durvalumab plus gemcitabine and cisplatin as first-line therapy. Patients must have measurable disease by RECIST 1.1, ECOG performance status 0–1, adequate organ function, and a tumor sample for central PD-L1 testing. Tumor responses will be followed with serial CT or MRI scans and participants will undergo ongoing safety monitoring during and after treatment. The main goals are to compare efficacy and safety between the two regimens in this patient population.

Why it matters

Who can join: the full rules

Key inclusion 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 exclusion Criteria:

* 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, dermatitis, ulceration, or psoriasis) requiring systemic treatment.

Where it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Tucson, Arizona, United States Recruiting
• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  Orange, California, United States Recruiting

+133 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.