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Small Molecule
Etrumadenant-Based Combinations for Colorectal Cancer (ARC-9 Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed metastatic colorectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death from any cause (up to approximately 3-7 years)
Awards & highlights
ARC-9 Trial Summary
This trial will study the effects of a new drug, etrumadenant, on participants with metastatic colorectal cancer.
Who is the study for?
Adults with metastatic colorectal cancer who've had no more than two prior treatments can join this trial. They must have a measurable tumor, be HIV and hepatitis negative, have good organ function and performance status (able to carry out daily activities), and agree to contraception. Exclusions include certain heart conditions, active infections, recent vaccines or surgeries, other cancers within 2 years (except some skin cancers), CNS metastases, autoimmune diseases, or previous treatment with similar drugs.Check my eligibility
What is being tested?
The study is testing combinations of Etrumadenant with other cancer drugs like Zimberelimab and Bevacizumab in patients whose disease has progressed after treatment. It's an open-label trial where everyone knows what treatment they're getting; it aims to see how well these drug combos work against advanced colorectal cancer.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to the medication components, increased risk of infection due to immune system effects from Zimberelimab or Etrumadenant, bleeding risks associated with Bevacizumab use on top of general chemotherapy side effects such as fatigue, digestive issues and blood cell count changes.
ARC-9 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a type of colorectal cancer that has spread.
Select...
My colorectal cancer worsened after one treatment including oxaliplatin or irinotecan with a biologic.
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My colorectal cancer worsened after up to two treatments including oxaliplatin, irinotecan, and a biologic.
Select...
My colorectal cancer worsened after one treatment including oxaliplatin or irinotecan and a biologic.
ARC-9 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until death from any cause (up to approximately 3-7 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death from any cause (up to approximately 3-7 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort A and B - Progression-free Survival (PFS)
Cohort C - Objective Response Rate (ORR)
Number of Participants With Treatment-emergent Adverse Events
Secondary outcome measures
AUV(0-336) of Zimberelimab
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of Etrumadenant and its Metabolites
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours [AUC(0-336)] of AB680
+11 moreARC-9 Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Etrumadenant + Zimberelimab + mFOLFOX-6 +/- BevacizumabExperimental Treatment4 Interventions
Participants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion.
Group II: AB680 + Etrumadent+ ZimberelimabExperimental Treatment3 Interventions
Participants will receive oral etrmadenant in combination with AB680 + zimberelimab by IV infusion.
Group III: mFOLFOX-6 +/- BevacizumabActive Control2 Interventions
Participants will receive mFOLFOX-6 +/- bevacizumab by IV infusion.
Group IV: RegorafenibActive Control1 Intervention
Participants will receive oral regorafenib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrumadenant
2018
Completed Phase 1
~130
Bevacizumab
2013
Completed Phase 4
~5280
Zimberelimab
2018
Completed Phase 1
~50
AB680
2018
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,085 Previous Clinical Trials
848,167 Total Patients Enrolled
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,870 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,789 Previous Clinical Trials
8,067,103 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any immune-boosting drugs in the last 4 weeks.I have active tuberculosis.I have a bleeding disorder that increases my risk of bleeding.I have never received immune checkpoint inhibitors for my condition.I have a history of lung scarring or inflammation not caused by infections.I am fully active or restricted in physically strenuous activity but can do light work.I have not taken any strong antibiotics in the last 2 weeks.I have had cancer spread to the lining of my brain or spinal cord.My blood and organs are functioning well.I have had a stem cell or organ transplant in the past.I have not had any cancer other than colorectal cancer in the last 2 years, except for non-dangerous skin cancer or a specific breast cancer.I have weak bones at risk of breaking.I have been treated with drugs targeting the adenosine pathway before.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.I have not received any live vaccines in the last 28 days.My cancer is a type of colorectal cancer that has spread.I haven't had cancer treatment in the last 4 weeks.I am currently on medication for hepatitis B.I have not had a heart attack or unstable heart conditions in the past 6 months.My cancer has a BRAF gene mutation, or I will get tested for it.You are expected to live for at least 3 more months.I cannot swallow pills.I am 18 years old or older.I agree to use birth control and not donate sperm for up to 180 days after my last treatment.My colorectal cancer worsened after one treatment including oxaliplatin or irinotecan with a biologic.My colorectal cancer worsened after up to two treatments including oxaliplatin, irinotecan, and a biologic.I have brain metastases that are untreated or getting worse.I have a condition that affects how my body absorbs pills.I have not had a severe infection in the last 4 weeks.My colorectal cancer worsened after one treatment including oxaliplatin or irinotecan and a biologic.I have or had an autoimmune disease or immune deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: mFOLFOX-6 +/- Bevacizumab
- Group 2: Regorafenib
- Group 3: AB680 + Etrumadent+ Zimberelimab
- Group 4: Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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