INTEGRATEIIb : A Randomised Phase III Open Label Study of Regorafenib + Nivolumab vs Standard Chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Oesophagus,Stomach

Trial Overview Read MoreRead more

This Phase III trial is trying to determine if a combined treatment of targeted and immunotherapy drugs (regorafenib and nivolumab) is more effective than the current standard chemotherapy treatments in people with advanced gastro-oesophageal cancer .
 

This trial is treating patients with advanced gastro-oesophageal cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has 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 had certain treatments, surgical procedures or drugs.

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

A Randomised Phase III Open Label Study of Regorafenib + Nivolumab vs Standard Chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Cooperative Group

Australasian Gastro-Intestinal Trials Group (AGITG)

Summary

This is a randomised trial with experimental and active comparator arms. Participants in the Experimental Arm will receive regorafenib and nivolumab (RegoNivo). 90mg of Regorafenib will be self-administered orally (3 x 30mg) days 1-21 of each 28-day treatment cycle; and nivolumab will be administered intravenously (240mg) day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion. Participants in the Active Comparator group will receive Standard Of Care treatment. Participants in this group will receive investigator choice chemotherapy with any of the following agents: taxane (paclitaxel or docetaxel), irinotecan, or oral trifluridine/tipiracil (TAS102). All treatment groups will receive Best Supportive Care (BSC).

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

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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