Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

Official Title

A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy

Keywords

Biliary Tract Cancer Cholangiocarcinoma Gallbladder Cancer M7824 Bintrafusp alfa (proposed INN) Transforming growth factor-beta First-line Platinum-Based Chemotherapy Programmed death-ligand 1 Metastatic Biliary Tract Cancer INTR@PID BTC 047 Biliary Tract Neoplasms Gallbladder Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC.
  • Availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory
  • Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy administered for locally advanced or metastatic disease. Only one prior treatment line is allowed
  • Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
  • Life expectancy >= 12 weeks as judged by the Investigator
  • Adequate hematological function defined by white blood cell (WBC) count >= 3 * 109/Litre with absolute neutrophil count (ANC) >= 1.5 * 109/Litre, lymphocyte count >= 0.5 * 109/Litre, platelet count >=75 * 109/Litre, and hemoglobin (Hgb) >= 9 grams/decilitre

  • Adequate hepatic function defined by a total bilirubin level =< 1.5 * upper limit of normal (ULN), an aspartate aminotransferase (AST) level =< 2.5 * ULN, and an alanine aminotransferase (ALT) level =<2.5 * ULN. For participants with liver involvement in their tumor, AST =< 5.0 * ULN and ALT =< 5.0 * ULN is acceptable
  • Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) =< 1.5 * ULN unless the participant is receiving anticoagulant therapy
  • Albumin >= 3.0 grams/decilitre
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
  • Adequate renal function defined by either creatinine =< 1.5 * ULN or an estimated creatinine clearance (CCr) > 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
  • Other protocol defined inclusion criteria could apply

You CAN'T join if...

  • Ampullary cancer is excluded
  • Significant acute or chronic infections
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Interstitial lung disease or its history
  • Participants who are not eligible for or have not been treated with 1L systemic chemotherapy
  • Anticancer treatment within 21 days before the start of study intervention
  • Concurrent treatment with nonpermitted drugs
  • Prior participation in a M7824 clinical trial
  • Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
  • Pregnancy or breast feeding
  • Systemic anticancer treatment after failing 1L platinum-based chemotherapy
  • Other protocol defined exclusion criteria could apply

Locations

  • UCSF Mount Zion Medical Ctr
    San Francisco California 94158 United States
  • Mayo Clinic Arizona
    Scottsdale Arizona 85259 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
EMD Serono Research & Development Institute, Inc.
Links
INTR@PID Clinical Trial Program Trial Awareness and Transparency website US Medical Information website, Medical Resources
ID
NCT03833661
Phase
Phase 2
Study Type
Interventional
Last Updated