Autopsy report · NCT04066491

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

“Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 2 months before it stopped.
• 309 participants enrolled.
• Results were posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

EMD Serono Research & Development Institute, Inc.

Sponsor type

Industry

Conditions

Biliary Tract Cancer; Cholangiocarcinoma; Gallbladder Cancer

Interventions

M7824; Placebo; Gemcitabine; Cisplatin

Participants

309

Sites

99

Countries

Argentina, Australia, Brazil, Chile, China, France, Germany, Italy, Japan, Poland, South Korea, Spain and more

Trials that died the same way

• To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
  “This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.” (66% match in meaning)
• A Study of Ponsegromab in People With Heart Failure
  “Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study” (65% match in meaning)
• GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
  “The study was terminated following assessment of the lack of efficacy of the study product by the Independent Data monitoring Committee for the study.” (62% match in meaning)
• Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
  “Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.” (61% match in meaning)
• SPIROCOR Coronary Outcome by Respiratory Stress Examination
  “Based on analyses of studies separately of the SCORE study, sponsor has decided to discontinue the Study. Data collected during the study will not be analyzed” (61% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.