Morpheus-CRC : A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Colorectal Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

This phase Ib/II trial is evaluating different combinations of immunotherapy-based treatments in patients with metastatic colorectal cancer that has not responded or gotten worse on other treatments.
 

This trial is treating patients with colorectal cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • 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 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

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Scientific Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Colorectal Cancer

Commercial Sponsor

Hoffmann-La Roche

Summary

In this trial, eligible patients will be randomly assigned to one of three treatment arms. In the active comparator arm, participants will continue to receive treatment with Regorafenib, administered orally on Days 1-21 of each 28 day cycle, until unacceptable toxicity or disease progression occurs. In Experimental Arm 1, participants will receive Atezolizumab, Imprime PGG and Bevacizumab until unacceptable toxicity or disease progression occurs. In this Arm, Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles or by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of 28-day cycles; Imprime PGG will be administered by IV infusion weekly on Days 1, 8, and 15 of each 21-day cycle; and Bevacizumab will be administered IV infusion on Day 1 of each 21-day cycle. In Experimental Arm 2, participants will receive Atezolizumab and Isatuximab. In this Arm, Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles or by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of 28-day cycles; and Isatuximab will be administered by IV infusion. In all Arms, participants who progress on treatment may have the option of receiving Atezolizumab and Cobimetinib, provided they meet the eligibility criteria.

Recruiting Hospitals Read MoreRead more

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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