Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer (POLEM)
POLEM:Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Exonuclease Domain Mutant Colon Cancer: A Phase 3 Randomised Study
Sponsor: Merck KGaA, Darmstadt, Germany
Terminated
POLEM encountered significant recruitment challenges. With little prospect of recruiting to target the decision to close was made.
Other terminated trials from Merck KGaA, Darmstadt, Germany
A PHASE3 clinical study on Microsatellite Instability and POLE Exonuclease Mutant Colon Cancer, this trial is terminated or withdrawn. The trial is conducted by Merck KGaA, Darmstadt, Germany and has accumulated 9 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Terminated PHASE3
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
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Nov 2022 — Jul 2024 [monthly]
Terminated PHASE3
Status: Active Not Recruiting → Terminated
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Sep 2021 — Nov 2022 [monthly]
Active Not Recruiting PHASE3
-
Apr 2021 — Sep 2021 [monthly]
Active Not Recruiting PHASE3
▶ Show 4 earlier versions
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Jan 2021 — Apr 2021 [monthly]
Active Not Recruiting PHASE3
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Jul 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Mar 2020 — Jul 2020 [monthly]
Recruiting PHASE3
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Mar 2019 — Mar 2020 [monthly]
Recruiting PHASE3
First recorded
Aug 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Merck KGaA, Darmstadt, Germany
- Royal Marsden NHS Foundation Trust
- University of Oxford
- University of Surrey
For direct contact, visit the study record on ClinicalTrials.gov .