A trial to learn how safe the combination of rilvegostomig and chemotherapy is and how well it works compared to durvalumab and chemotherapy in adults with advanced biliary tract cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Apr 2026 → ongoing

Decision date (initial)

2026-03-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2025-523085-24-00

ClinicalTrials.gov

NCT07221253

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Pharmacogenetic, Therapy

To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of Overall Survival (OS) in the PD-L1 ≥ 1% population.

Secondary objectives 3

1. To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of OS in the intented to dose (ITT) population.
2. To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of PFS in the PD-L1 ≥ 1% population
3. To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of PFS in the ITT population

Conditions and MedDRA coding

Biliary Tract Cancer

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
2. Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting.
3. Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
4. Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
5. 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.
6. Adequate bone marrow and organ function.

Exclusion criteria 6

1. Ampullary carcinoma.
2. Any prior systemic therapy received for unresectable locally advanced or metastatic BTC.
3. Any prior exposure to any therapy targeting immune-regulatory receptors or mechanisms.
4. Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
5. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
6. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy

Secondary endpoints 1

1. Progression Free Survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

7 EU/EEA countries · 46 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications