Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer (NCT06467357) | Clinical Trial Compass
RecruitingPhase 3
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
United States, Australia, Austria620 participantsStarted 2024-08-12
Plain-language summary
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 durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.
* Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is \> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
* Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.
* Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.
* Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)
* WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
* Adequate organ and bone marrow function within 14 days before randomization.
* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.
* Minimum life expectancy of 12 weeks.
Key Exclusion Criteria:
* Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.
* Histologically confirmed ampullary carcinoma.
* Any other medical conditions such as clinically significant cardiac or psycholog…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a combination of T-DXd and rilvegostomig against standard of care — does my tumor have HER2 IHC 3+ expression, since that seems to be the key population the survival results will focus on, and would my biopsy results even make me eligible to discuss this?
2Since the trial starts with a safety run-in phase before the randomized portion begins, what does that mean for what's already known about the safety of combining T-DXd with rilvegostomig, and are there specific side effects from this combination that you'd want me to watch out for?
3If I were randomized to the standard of care arm instead of the experimental combination, what would that treatment actually look like for my stage and type of biliary tract cancer, and is that something you'd consider a reasonable option for me on its own?
4T-DXd is an antibody-drug conjugate and rilvegostomig is an immunotherapy checkpoint inhibitor — given that I'd be combining two types of treatment, how would you manage the potential risks compared to receiving either one alone or just standard chemotherapy?
5Before we discuss this trial, is there a standard first-line treatment you would normally recommend for my situation, and would participating in this study mean delaying or replacing something that might have a more established track record for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig
Timeframe: Until all patients have completed at least 1 full Cycle (each cycle is 21 days)
2
Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the FAS (HER2 IHC 3+) population
Timeframe: From date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)