RECRUITING

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

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Conditions

Biliary Tract CancerHER2HER2 expressing BTCTrastuzumab deruxtecanT-DXdRilvegostomig

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-08-12
Study Completion:2029-05-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06467357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations;
  2. * Male and female;
  3. * 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.
  4. * histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC;
  5. * Provision of FFPE tumor sample that is no older than 3 years;
  6. * At least one target lesion assessed by the Investigator based on RECIST v1.1 (randomized portion only);
  7. * WHO/ECOG performance status of 0 or 1;
  8. * Adequate organ and bone marrow function within 14 days before randomization;
  9. * Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential;
  1. * Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines;
  2. * histologically confirmed ampullary carcinoma;
  3. * history of substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions;
  4. * 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;
  5. * 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;
  6. * 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;
  7. * 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;
  8. * Corrected QT interval (QTcF) prolongation to \> 470 msec (females) or \> 450 msec (males) based on average of the screening triplicate 12-lead ECG;
  9. * History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening;
  10. * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder;
  11. * Prior pneumonectomy (complete);
  12. * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals;
  13. * Active primary immunodeficiency, known uncontrolled active HIV infection or HCV;
  14. * Pregnant or breastfeeding female patients, or patients who are planning to become pregnant;
  15. * 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).

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Scottsdale, Arizona, 85259
United States
Research Site
Tucson, Arizona, 85710
United States
Research Site
Fullerton, California, 92835
United States
Research Site
Glendale, California, 91204
United States
Research Site
La Jolla, California, 92093
United States
Research Site
Los Angeles, California, 90033
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Fort Myers, Florida, 33901
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Saint Petersburg, Florida, 33705
United States
Research Site
West Palm Beach, Florida, 33401
United States
Research Site
Atlanta, Georgia, 30309
United States
Research Site
Niles, Illinois, 60714
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Albuquerque, New Mexico, 87102
United States
Research Site
New York, New York, 10032
United States
Research Site
Greenville, South Carolina, 29605
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Fort Worth, Texas, 76104
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12
Study Completion Date2029-05-16

Study Record Updates

Study Start Date2024-08-12
Study Completion Date2029-05-16

Terms related to this study

Keywords Provided by Researchers

  • Biliary Tract Cancer
  • HER2
  • HER2 expressing BTC
  • Trastuzumab deruxtecan
  • T-DXd
  • Rilvegostomig

Additional Relevant MeSH Terms

  • Biliary Tract Cancer