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Isatuximab for Colorectal Cancer

Phase 1 & 2

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to death from any cause (up to 4 years)

Awards & highlights

Study Summary

This trial is designed to study the safety and preliminary effectiveness of various immunotherapy-based treatments for patients with metastatic colorectal cancer that has stopped responding to first- and second-line therapies.

Eligible Conditions

Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization up to death from any cause (up to 4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization up to death from any cause (up to 4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to death from any cause (up to 4 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

Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary outcome measures

Disease Control Rate (DCR), as Determined by the Investigator Per RECIST v1.1

Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1

Overall Survival (OS)

+3 more

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Atezolizumab + Selicrelumab + BevacizumabExperimental Treatment3 Interventions

Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.

Group II: Atezolizumab + Regorafenib + AB928Experimental Treatment3 Interventions

Group III: Atezolizumab + RegorafenibExperimental Treatment2 Interventions

Group IV: Atezolizumab + LOAd703Experimental Treatment2 Interventions

Group V: Atezolizumab + IsatuximabExperimental Treatment2 Interventions

Group VI: Atezolizumab + Imprime PGG + BevacizumabExperimental Treatment3 Interventions

Group VII: Atezolizumab + IdasanutlinExperimental Treatment2 Interventions

Group VIII: Regorafenib (Control)Active Control1 Intervention

Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regorafenib

2014

Completed Phase 2

~1580

Atezolizumab

2017

Completed Phase 3

~5860

Imprime PGG

2014

Completed Phase 2

~160

Bevacizumab

2013

Completed Phase 4

~5280

Isatuximab

2016

Completed Phase 3

~370

Selicrelumab

2014

Completed Phase 1

~240

Idasanutlin

2018

Completed Phase 2

~380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,958 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,406 Total Patients Enrolled

Frequently Asked Questions

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

What is the maximum capacity of participants for this investigation?

"Currently, this trial is not recruiting patients. Its initial posting date was September 27th 2018 and its last update was on the 2nd of September 2022. For individuals looking for other studies related to colorectal carcinoma, there are 1061 trials that are now enrolling participants; 719 of these specifically involve AB928."

Answered by AI

Does this research endeavor require any new participants at the present time?

"At this time, the trial is no longer recruiting participants. The original posting was on September 27th 2018 and it was last edited 2 years later in 2020. Those searching for other trials may be interested to note that 1061 studies are currently accepting colorectal carcinoma candidates while 719 medical centres are enrolling patients for AB928 treatment plans."

Answered by AI

What prior research endeavors have included AB928 as a component?

"Currently, 719 studies involving AB928 are underway. Of these, 156 have reached Phase 3 and are being tested at 34451 medical sites around the world with most located in Taibei City Taiwan."

Answered by AI

How many venues are facilitating this research endeavor?

"Currently, this experiment is being conducted across 5 sites, with the nearest ones located in New york City and New Haven. Additionally, Duarte has a medical centre participating as well as five other locales which must be taken into account when choosing your closest site for enrollment to minimize travel requirements."

Answered by AI

In what conditions is AB928 typically prescribed?

"AB928 is a common treatment option for recurrent platinum-resistant epithelial ovarian cancer. It can also be beneficial in treating conditions like refractory multiple myeloma, malignant neoplasms and recurrent primary peritoneal cancer that has grown resistant to platinum therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

2018. "A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03555149.