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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

TwoPhase Two

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy | Bowel (colorectum)Rectum

Trial Overview Read MoreRead more

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 removed .
 

This trial is treating patients with Rectal Cancer.

This is a systemic therapy and radiotherapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • 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.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

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.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Nikki Cross
n.cross@alfred.org.au
03 9076 3534

Box Hill Hospital Medical Oncology
Box Hill
Yvonne Chan
yvonne.chan@monash.edu
03 9895 3203

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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