M7824 for Biliary Tract Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria, Bologna, Italy
Biliary Tract Cancer+4 More
M7824 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Biliary Tract Cancer

Study Summary

This study is evaluating whether a new drug called M7824 can help people with advanced or metastatic biliary tract cancer.

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Eligible Conditions

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
  • Cholangiocarcinoma
  • Gallbladder Neoplasms
  • Cancer of the Gallbladder
  • Biliary Tract Cancer (BTC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether M7824 will improve 2 primary outcomes and 31 secondary outcomes in patients with Biliary Tract Cancer. Measurement will happen over the course of At Day 1 and Day 29.

Day 29
Serum Concentration at End of Infusion (CEOI) of M7824
Day 337
Serum Pre-Dose Concentrations (Ctrough) of M7824
Day 555
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
Day 555
Overall Survival (OS)
Day 555
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status
Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Year 5
Concentration of M7824 at the end of Infusion (Ceoi)
Concentration of M7824 at the end of the Dosing Interval (C trough)
Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee
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
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
Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
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)
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
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Duration of Response (DOR) Assessed by Independent Review Committee (IRC)
Immunogenicity as measured by Anti-drug Antibodies Concentration
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Day 555
Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status
Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Number of Participants With Positive Antidrug Antibodies (ADA)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
Percentage of Participants With Confirmed Objective Response as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) According to Microsatellite Instability (MSI) Status

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
M7824

This trial requires 159 total participants across 2 different treatment groups

This trial involves 2 different treatments. M7824 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

M7824
Drug
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from first treatment to planned final assessment at approximately 2.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly time from first treatment to planned final assessment at approximately 2.5 years for reporting.

Closest Location

MD Anderson Cancer Center - Unit - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
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
Albumin >= 3.0 grams/decilitre
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes biliary tract cancer?

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In a recent study, findings suggest that biliary tract cancer is caused by a combination of environmental and genetic factors, and it may be related to chronic occupational exposure. However, the data are limited by the lack of data on exposure and genetic susceptibility.

Unverified Answer

What is biliary tract cancer?

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Biliary tract cancer is a cancer that forms in the bile duct, a hollow canal that forms the main part of the hepatic tract. It causes swelling, pain, and other symptoms in a specific part of the body. Chronic liver disease is common in those with biliary tract cancer. It also increases the risk of getting liver cancer. The signs of bile duct cancer typically start in the midsection or upper right area of the abdomen, especially if it is painless. Liver tumors are uncommon in people with cirrhosis and can be found either on the surface of the liver or inside the organ. Tissue from the liver may appear yellow-white in the stool.

Unverified Answer

What are common treatments for biliary tract cancer?

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Treatment for patients with biliary tract cancer is similar to other types of cancer, but it is unique in some aspects, such as the role of neoadjuvant chemotherapy.

Unverified Answer

What are the signs of biliary tract cancer?

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Most commonly, symptoms include an increased liver function test result. Biliary tract cancers may cause jaundice due to obstruction of the biliary ducts by a mass. Other signs include abdominal pain, unexplained weight loss or an unintentional weight loss over three months, and itchiness. Abdominal bleeding may or may not be present.  \n

Unverified Answer

How many people get biliary tract cancer a year in the United States?

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It was not clear whether the biliary cancer diagnosed to be due to choledochal cyst, benign or malignant. It is necessary for health care provider's to keep surveillance system in the areas with high risk of biliary cancer.

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Can biliary tract cancer be cured?

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There is no single method of treatment for biliary tract cancers. However, the results of the current study showed that the cure/palliative treatment can be improved. Survival rate of patients with large tumors could be improved.

Unverified Answer

What are the chances of developing biliary tract cancer?

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Only 18% of patients would have developed biliary tract cancer after 12 years. The highest incidence rate was in cases with concomitant cirrhosis (32%), chronic infection, and carcinogenesis secondary to bile duct stones (26%), while the lowest rate was in cases with only chronic pancreatitis (only 9%). To prevent progression, a long, early treatment regimen is recommended.

Unverified Answer

Have there been any new discoveries for treating biliary tract cancer?

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Currently there are 2 treatment options: surgery and [immunotherapy](https://www.withpower.com/clinical-trials/immunotherapy). Surgery has the best prognosis, but many patients will recur after the 1st procedure, and sometimes patients will even die. The recurrence rates of resection are as high as 40%; the mortality rates are 2 to 5%. The only way to guarantee that surgeons obtain a radical resection and that their patients will survive is to start immunotherapy at the early stage. At the present time, the use of adjuvant chemotherapy after resection is recommended.

Unverified Answer

What is the primary cause of biliary tract cancer?

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Primary biliary tract cancer may result from a genetic mutation in the β-catenin Tcf factor 3 gene of patients with a hepatic background, but more advanced age, sex, gallstones and gallbladder cancer may also play a part in the development of the disease.

Unverified Answer

How does m7824 work?

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The antitumor activity of M7824 in vivo is correlated with changes in expression of Bcl-2 and Bcl-xL and concurrent sensitization of the cells to chemotherapeutic drugs. Thus, M7824 might represent a new approach to overcome chemoresistance in tumors which are associated with loss of apoptosis.

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What are the common side effects of m7824?

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Mild nausea and vomiting were seen in 5 of the 16 patients in the 100 mg tiwaferan-100 arm and 2 of 16 in the 400 mg tiwaferan-100 arm, respectively. No patients in either arm experienced severe grade toxicity or severe toxicity to any specific dose/schedule. M7824 induced no toxicities that would warrant cessation. Based on the aforementioned clinical data, we conclude that M7824 is experiencing a good safety profile compared to that of other biologics and its own monoclonal antibody, m1488.

Unverified Answer

What is m7824?

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The protein's name originates from the molybdenum cofactor, or Mo-pterin, part of the electron transport chain of bacterial and chloroplastic photosynthesis. However, as the name of the protein appears to be derived from the name of a species it has never been found in. [http://pubs.biot.cs.ic.edu/biot/biochips.csp_ref=refs?ref_id=cobi_mf2&ref_ref_id=bdb_mfe.

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