Description:
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.
Title
- Brief Title: M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
- 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
Clinical Trial IDs
- ORG STUDY ID:
MS200647_0047
- SECONDARY ID:
2018-003707-19
- NCT ID:
NCT03833661
Conditions
- Biliary Tract Cancer
- Cholangiocarcinoma
- Gallbladder Cancer
Interventions
Drug | Synonyms | Arms |
---|
M7824 | Bintrafusp alfa | M7824 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
M7824 | Experimental | | |
Eligibility Criteria
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 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 *
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
- Systemic anticancer treatment after failing 1L platinum-based chemotherapy
- Other protocol defined exclusion criteria could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) Assessed by Independent Review Committee (IRC) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Durable Response of at Least 6 Months According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Concentration of M7824 at the end of Infusion (Ceoi) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Concentration of M7824 at the end of the Dosing Interval (C trough) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity as measured by Anti-drug Antibodies Concentration |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Confirmed Objective Response According to RECIST Version 1.1 Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) According to (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Durable Response According to RECIST Version 1.1 Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status |
Time Frame: | Time from first treatment to planned final assessment at approximately 2.5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
Trial Keywords
- M7824
- Bintrafusp alfa (proposed INN)
- Transforming growth factor-beta
- First-line Platinum-Based Chemotherapy
- Programmed death-ligand 1
- Metastatic Biliary Tract Cancer
- Cholangiocarcinoma
- Gallbladder cancer
- INTR@PID BTC 047
Last Updated
February 18, 2021