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Checkpoint Inhibitor

Cibisatamab + Atezolizumab for Colorectal Cancer

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic disease not amenable to local treatment
Experienced disease progression during or within 3 months following the last administration of approved standard therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is looking at a new colorectal cancer treatment combining two drugs, cibisatamab and atezolizumab, given after pretreatment with obinutuzumab. The trial will assess the safety and efficacy of this combination therapy and will enroll patients who have Stage IV microsatellite stable metastatic colorectal cancer and high carcinoembryonic antigen-related cell adhesion molecule 5 expression.

Who is the study for?
This trial is for adults with Stage IV colorectal cancer that's spread and can't be removed by surgery. They must have tried at least two chemotherapy regimens, have a specific tumor marker (CEACAM5), good physical function, no HIV or hepatitis, and agree to contraception. Excluded are those with uncontrolled symptoms, autoimmune diseases, recent vaccinations or treatments that conflict with the study drugs.Check my eligibility
What is being tested?
The trial tests cibisatamab combined with atezolizumab after obinutuzumab pretreatment in patients whose tumors express CEACAM5 and who've progressed on other therapies. It aims to assess safety, effectiveness, how the body processes the drugs (pharmacokinetics), and immune response.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of these drugs such as fever or chills; organ inflammation; increased risk of infections; allergic responses; fatigue; liver enzyme changes; blood disorders like low white cell counts which could lead to higher infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread and cannot be treated with surgery or radiation.
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My condition worsened within 3 months after my last standard treatment.
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My blood and organs are functioning well.
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I am fully active or can carry out light work.
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I have not been treated with regorafenib or TAS-102.
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My tumor shows high levels of a specific protein marker.
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I agree to use contraception or remain abstinent and not donate sperm during and for 3 months after treatment.
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I have tested negative for hepatitis B or have a controlled infection.
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My cancer is a type of colon or rectal cancer confirmed by a lab test.
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My cancer has spread and cannot be treated with surgery or radiation.
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My cancer is a type of colon or rectal cancer confirmed by a biopsy.
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My tumor shows high levels of a specific protein, confirmed by a test.
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I am fully active or can carry out light work.
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I have tested negative for hepatitis B or have cleared the virus.
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My tumor is not highly variable at the genetic level.
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My tumor is not highly variable at the genetic level.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (ORR)
Percentage of Participants with Adverse Events (AEs)
Secondary outcome measures
AUC0-t of Atezolizumab
AUC0-t of Obinutuzumab
Area Under the Concentration-Time Curve (AUC0-t) for Cibisatamab
+17 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Obinutuzumab Pretreatment (OpT) + Cibisatamab + AtezolizumabExperimental Treatment4 Interventions
Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Cibisatamab
2019
Completed Phase 1
~50
Tocilizumab
2012
Completed Phase 4
~1840
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,003 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,431 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03866239 — Phase 1
Colorectal Cancer Research Study Groups: Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab
Colorectal Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03866239 — Phase 1
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03866239 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other experiments have employed Cibisatamab to analyze its efficacy?

"Currently, there are 498 active trials exploring cibisatamab's efficacy and safety. Of those studies, 95 have reached Phase 3 of the trial process. Although most research is centred in Harvey, Illinois, Cibisatamab is being tested at over 24000 locations worldwide."

Answered by AI

What are the safety implications associated with Cibisatamab use?

"Due to the limited clinical data available on Cibisatamab, our experts assigned it a safety score of 1. This is because this drug is still being tested in Phase 1 trials and its efficacy has yet to be seen."

Answered by AI

Has a similar endeavor been attempted prior to this venture?

"At present, 498 Cibisatamab studies are being conducted across 82 countries and 1935 cities. The initial clinical trial for this drug was carried out by Hoffmann-La Roche in 2008 and included 720 patients. This study achieved Phase 2 FDA approval before concluding; since then a further 348 similar trials have been completed worldwide."

Answered by AI

Would this research endeavor be open to new participants?

"Per the clinical trials website, this medical research project is presently inactive with regards to recruiting volunteers. It was first posted on May 7th 2019 and last updated October 28 2022. Fortunately for those interested in participating in a trial, there are 1,852 other studies currently searching for patients."

Answered by AI

What therapeutical applications is Cibisatamab employed for?

"Cibisatamab may be effective in treating small cell lung cancer, systemic juvenile idiopathic arthritis, and certain malignant neoplasms."

Answered by AI
~8 spots leftby Mar 2025