Rilvegostomig + Durvalumab for Biliary Tract Cancer

(AB02 Trial)

Not yet recruiting at 81 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: Ampullary carcinoma, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: approximately 4 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatment combinations to determine which is more effective for advanced biliary tract cancer, a cancer affecting the bile ducts and gallbladder. One group receives durvalumab (an immunotherapy drug) with chemotherapy, while the other receives rilvegostomig (an experimental treatment) with the same chemotherapy. Researchers aim to discover which treatment is more effective and safe. Individuals with advanced biliary tract cancer that cannot be surgically removed and have not yet received treatment for advanced disease may qualify to participate. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain cancer treatments or with conditions requiring chronic steroid or immunosuppressive treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining rilvegostomig with chemotherapy generally results in a manageable safety profile. Most side effects are not severe and can be effectively managed. In earlier studies, patients tolerated the combination of rilvegostomig and chemotherapy well, and it effectively targeted cancer cells.

Durvalumab has been used in other treatments and has a well-documented safety profile. Patients have experienced side effects like tiredness, but these are usually manageable and not life-threatening.

Overall, both treatments in this study are intended for use with chemotherapy and have been tolerable in past research. Participants have reported manageable side effects, which is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Rilvegostomig for biliary tract cancer because it introduces a novel approach by using a new active ingredient alongside traditional chemotherapy. While standard treatments like Gemcitabine and Cisplatin target fast-dividing cancer cells, Rilvegostomig offers an innovative mechanism that could enhance the immune system's ability to fight cancer, potentially improving patient outcomes. This combination could make a significant difference by boosting the effectiveness of the existing chemotherapy regimen, offering hope for better results than current options alone.

What evidence suggests that this trial's treatments could be effective for biliary tract cancer?

Research has shown that combining rilvegostomig with chemotherapy may help treat biliary tract cancer (BTC). In one study, 31% of patients experienced tumor shrinkage. Another study found that 73% of patients did not experience cancer progression for 6 months. Rilvegostomig appears to work well with chemotherapy and is generally safe. In this trial, some participants will receive rilvegostomig with chemotherapy. Meanwhile, durvalumab, an immunotherapy drug already used for other cancers, helps the immune system fight cancer cells. Other participants in this trial will receive durvalumab with chemotherapy. These findings suggest that both treatments could be effective options for BTC. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced biliary tract cancer, including gallbladder cancer, who haven't had treatment before. Participants should be fit enough for chemotherapy and have no prior history of other cancers or significant heart conditions.

Inclusion Criteria

My bile duct cancer cannot be removed by surgery and has not been treated in its advanced stage.

My cancer is a type of bile duct or gallbladder cancer.

My cancer's PD-L1 status is known from a lab test.

Exclusion Criteria

I have been diagnosed with ampullary carcinoma.

I have received treatment for advanced bile duct cancer that couldn't be removed by surgery.

I have been treated with drugs that target the immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either rilvegostomig or durvalumab in combination with chemotherapy (gemcitabine and cisplatin) as first-line treatment for advanced biliary tract cancer

approximately 4 years

Follow-up

Participants are monitored for safety, efficacy, and progression-free survival after treatment

Up to 12 weeks post disease progression

What Are the Treatments Tested in This Trial?

Interventions

• Durvalumab
• Rilvegostomig

Trial Overview The study compares the effectiveness and safety of two treatments: Rilvegostomig combined with gemcitabine/cisplatin versus Durvalumab also combined with gemcitabine/cisplatin in patients receiving their first line of treatment.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 2 Interventions

Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Group II: Control Arm Active Control 2 Interventions

Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS4199

A phase 3, randomized study of adjuvant rilvegostomig ... ARTEMIDE-Biliary01 will investigate the efficacy of rilvegostomig plus standard of care adjuvant chemotherapy in patients with BTC after curative intent ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06109779

Study Details | NCT06109779 | Rilvegostomig + ... A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT485446

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in ... Efficacy and safety data are shown in the Table. The 6-month PFS rate was 73.0%; median PFS was 8.3 months. Median PFS was numerically longer in pts with PD-L1 ...

4. ccanewsonline.com ccanewsonline.com/issues/2025/september-2025-vol-6-no-3/rilvegostomig-plus-chemotherapy-in-advanced-biliary-tract-cancer

Rilvegostomig Plus Chemotherapy in Advanced Biliary ... Overall survival data were not mature after a median follow-up of 9.8 months. The ORR was 31%, with 31% of patients achieving partial responses and 62.1% ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4080

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in ... Conclusions: Rilve plus CTx demonstrated promising efficacy with a manageable safety profile and sustained target engagement. Longer follow-up ...

6. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D781PC00001

Phase 3 Study of T-DXd and Rilvegostomig versus SoC in ... The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and ...