Health Trials

Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results.

Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gemcitabine

    Drug

    Standard of care chemotherapy by intravenous infusion

  • Cisplatin

    Drug

    Standard of care chemotherapy by intravenous infusion

  • Durvalumab

    Drug

    Standard of care immunotherapy by intravenous infusion

  • Trastuzumab deruxtecan

    Drug

    Experimental therapy by intravenous infusion

  • Rilvegostomig

    Drug

    Experimental therapy by intravenous infusion

Treatment groups

620 Participants
are divided into 3 treatment groups
Group A: Trastuzumab deruxtecan + rilvegostomigExperimental treatment 2 interventions
Group B: Trastuzumab deruxtecanExperimental treatment 1 intervention
Group C: Standard of CareActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig

Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.

Time frame
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

Overall survival (OS) in FAS (HER2 IHC 3+) population OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS.

Time frame
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)

Secondary outcomes

1

To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population

Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.

Time frame
From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
2

To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population

Overall Survival (OS) in FAS (HER2 IHC 3+) population. OS definition as above.

Time frame
From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
3

To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population

Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.

Time frame
From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
4

To further evaluate efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
Apply now