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RecruitingLast updated:15 August 2023

Ave-Rec study: This phase II trial is evaluating the addition of an immunotherapy drug following long-course chemo-radiotherapy in patients with a locally advanced rectal cancer that is able to be surgically removedPhase II Trial PD-L1/PD-1 Blockade Avelumab (MSB0010718C) With Chemoradiotherapy for Locally Advanced ResectableT3b-4/N1-2 Rectal Cancer

Clinical summary

Summary

This trial is investigating the inclusion of avelumab post long-course chemo-radiotherapy in patients with resectable locally advanced rectal cancer. It is hypothesised that this may enhance the pathological and imaging response rates whilst potentially reducing the relapse rates. Participants will receive standard long course chemoradiotherapy (LCCRT) treatment with radiotherapy and 5-fluorouracil (5 FU)/Capecitabine for 6 weeks, this then followed by 4 cycles of Avelumab and then surgical resection. The trial will measure disease response just prior to surgery and participants will be followed up for a minimum of 18 months (from study entry) and up to 42 months.

Age

People18+

Phase

II

Trial Acronym

Ave-Rec study

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Trial Identifiers

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Commercial Sponsor

Peter MacCallum Cancer Centre

Scientific Title

Phase II Trial PD-L1/PD-1 Blockade Avelumab (MSB0010718C) With Chemoradiotherapy for Locally Advanced ResectableT3b-4/N1-2 Rectal Cancer

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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