M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

  • Interventional
  • Recruiting
  • NCT03833661
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria

         - Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC.

         - Availability of tumor (primary or metastatic) archival material or fresh biopsies (collected within 28 days before first administration) of study intervention is mandatory

         - Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy

         - Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1

         - Eastern Cooperative Oncology Group (ECOG) 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 * 10^9/Litre with absolute neutrophil count (ANC) >= 1.5 * 109/Litre, lymphocyte count >= 0.5 * 10^9/Litre, platelet count >=75 * 10^9/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

        Exclusion Criteria:

         - 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

         - Other protocol defined exclusion criteria could apply

At a Glance

National Government IDNCT03833661

IRB#IRB19-0311

Lead SponsorEMD Serono Research & Development Institute, Inc.

Lead PhysicianChih-Yi Liao

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting