Clinical trial NCT06467357: Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Official title: DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Biliary Tract Cancer
Keywords: Biliary Tract Cancer
HER2
HER2 expressing BTC
Trastuzumab deruxtecan
T-DXd
Rilvegostomig
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

* Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations;
* Male and female;
* Unresectable, previously untreated, locally advanced or metastatic BTC. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is \> 6 months (180 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;
* Provision of FFPE tumor sample that is no older than 3 years;
* 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;
* 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;

Key Exclusion Criteria:

* Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines;
* histologically confirmed ampullary carcinoma;
* history of substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions;
* 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;
* medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke;
* Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment;
* active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening;
* Corrected QT interval (QTcF) prolongation to \> 470 msec (females) or \> 450 msec (males) based on average of the screening triplicate 12-lead ECG;
* History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening;
* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder;
* Prior pneumonectomy (complete);
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals;
* Active primary immunodeficiency, known uncontrolled active HIV infection or HCV;
* Pregnant or breastfeeding female patients, or patients who are planning to become pregnant;
* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 6 months prior to randomization, or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study (only randomized portion).

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
measure: 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
timeFrame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
measure: To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population
timeFrame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
measure: 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
timeFrame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
measure: 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
timeFrame: 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)
measure: To further evaluate efficacy of T-DXd monotherapy vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: 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)
measure: To further evaluate the efficacy of T-DXd with rilvegostomig vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: 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)
measure: To further evaluate the efficacy of T-DXd monotherapy vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: 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)
measure: To further evaluate efficacy of T-DXd with rilvegostomig vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
measure: To further evaluate efficacy of T-DXd monotherapy vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
measure: To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Overall survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
timeFrame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
measure: To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of PFS in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: From the date of randomisation until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
measure: To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Duration of response in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: From the date of first response until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
measure: To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Objective response rate in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
timeFrame: 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)
measure: To assess the safety and tolerability of T-DXd with rilvegostomig vs Standard of Care
timeFrame: 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)
measure: To assess the safety and tolerability of T-DXd monotherapy vs Standard of Care
timeFrame: 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)
measure: To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on a summary of symptomatic AEs
timeFrame: Until End of Study (estimated up to 50 months)
measure: To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on a summary of symptomatic AEs
timeFrame: Until End of Study (estimated up to 50 months)
measure: To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs
timeFrame: Until End of Study (estimated up to 50 months)
measure: To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs Standard of Care
timeFrame: Until End of Study (estimated up to 50 months)
measure: To assess time to deterioration in physical functioning in patients treated with T-DXd monotherapy vs Standard of care
timeFrame: Until End of Study (estimated up to 50 months)
measure: To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy
timeFrame: Until End of Study (estimated up to 50 months)
measure: To assess the pharmacokinetics of T-DXd, total anti- HER2 antibody, DXd and rilvegostomig in serum
timeFrame: From the time of informed consent until 90 days after the last dose of T-DXd and rilvegostomig
measure: To investigate the immunogenicity of T-DXd and of rilvegostomig
timeFrame: From the time of informed consent until 30 and 90 days after the last dose of T-DXd and rilvegostomig, respectively
measure: To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on overall side-effect bother
timeFrame: Until End of Study (estimated up to 50 months)
measure: To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on overall side-effect bother
timeFrame: Until End of Study (estimated up to 50 months)
measure: To assess the safety and tolerability of T-DXd with rilvegostomig vs T-DXd monotherapy
timeFrame: 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)
measure: To describe patient-reported tolerability of T-DXd with rilvegostmog in comparison to T-DXd monotherapy based on overall side-effect bother
timeFrame: Until End of Study (estimated up to 50 months)
Other outcomes:
Locations:
city: Scottsdale
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Tucson
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city: Niles
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city: Towson
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state: Maryland
city: Worcester
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city: Detroit
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city: Grand Rapids
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city: Rochester
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city: Saint Louis
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state: Virginia
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city: Hangzhou
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city: Harbin
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city: Hefei
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city: Hefei
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city: Hohhot
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city: Jinan
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city: Luoyang
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city: Nanchang
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city: Nanning
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city: Nantong
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city: Shanghai
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city: Shanghai
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city: Shenyang
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city: Shenzhen
country: China
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city: Tianjin
country: China
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city: Wuhan
country: China
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city: Xi'an
country: China
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city: Zhengzhou
country: China
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city: Zhengzhou
country: China
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
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city: Praha 5
country: Czechia
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city: Brest
country: France
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city: Clichy Cedex
country: France
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city: Dijon
country: France
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city: Lille
country: France
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city: Lyon
country: France
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city: Marseille
country: France
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city: Montpellier
country: France
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city: Nimes
country: France
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city: Pessac
country: France
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city: Villejuif
country: France
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city: Berlin
country: Germany
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city: Bonn
country: Germany
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city: Dresden
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
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city: Freiburg
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Shatin
country: Hong Kong
facility: Research Site
city: Dehradun
country: India
facility: Research Site
city: Delhi
country: India
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city: Kolkata
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mumbai
country: India
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city: Vadodara
country: India
facility: Research Site
city: Varanasi
country: India
facility: Research Site
city: Firenze
country: Italy
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city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Naples
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Tricase
country: Italy
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Chiba-shi
country: Japan
facility: Research Site
city: Fukuyama-shi
country: Japan
facility: Research Site
city: Hirakata-shi
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Kanazawa
country: Japan
facility: Research Site
city: Kashiwa
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Kita-gun
country: Japan
facility: Research Site
city: Kitaadachi-gun
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Kumamoto-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
facility: Research Site
city: Maebashi-shi
country: Japan
facility: Research Site
city: Mitaka-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
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city: Nagoya-shi
country: Japan
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city: Osaka-shi
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sakai-shi
country: Japan
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city: Sapporo-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
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city: Suita-city
country: Japan
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city: Sunto-gun
country: Japan
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city: Ube-shi
country: Japan
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city: Wakayama-shi
country: Japan
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city: Yokohama-shi
country: Japan
facility: Research Site
city: Busan
country: Korea, Republic of
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city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Hwasun-gun
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: Research Site
city: George Town
country: Malaysia
facility: Research Site
city: Johor Bahru
country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
city: Rotterdam
country: Netherlands
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city: Cebu City
country: Philippines
facility: Research Site
city: Makati
country: Philippines
facility: Research Site
city: Pasig City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Ar Riyāḑ
country: Saudi Arabia
facility: Research Site
city: Dammam
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Kaohsiung City
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Mueang
country: Thailand
facility: Research Site
city: Naimuang
country: Thailand
facility: Research Site
city: Ongkharak
country: Thailand
facility: Research Site
city: Sisaket
country: Thailand
facility: Research Site
city: Altındağ
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Mezitli
country: Turkey
facility: Research Site
city: Yakutiye
country: Turkey
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Greater London
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh city
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Vinh
country: Vietnam
facility: Research Site
Study officials:
References: