Autopsy report · NCT03637764

Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

“Study was stopped after interim analysis for 4 cohorts (HCC, SCCHN, EOC, and GBM) indicated that the results did not fulfill the preplanned interim analysis criteria to move to Phase 2 stage 2 in all 4 cohorts.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 9 months before it stopped.
• 107 participants enrolled.
• Results were posted on the registry 1 year 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Sanofi

Sponsor type

Industry

Conditions

Neoplasm

Interventions

Isatuximab SAR650984; Atezolizumab

Participants

107

Sites

26

Countries

Belgium, Canada, Czechia, Italy, Netherlands, Spain, Taiwan, United States

Trials that died the same way

• A Study of Isatuximab-based Therapy in Participants With Lymphoma
  “Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern” (81% match in meaning)
• Moxonidine in Patients Undergoing Vascular Surgery
  “Study was stopped after pre-definied interim analysis because of no effects” (75% match in meaning)
• A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
  “Study was stopped following interim analysis.” (75% match in meaning)
• Adherence to Antidepressant Treatment in Subjects With Depression
  “The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.” (73% match in meaning)
• Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
  “This study was terminated early due to other competing trials, therefore did not go on to the Phase II portion of the study.” (71% 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.