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Monoclonal Antibodies
Chemoimmunotherapy for Colon Cancer
Phase 2
Waitlist Available
Led By Atif Iqbal, MD
Research Sponsored by Baylor College of Medicine
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 3-12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate if a therapy combining chemotherapy and an anti-PD-L1 mAb can improve outcomes for colon cancer patients.
Who is the study for?
This trial is for adults over 18 with resectable, non-metastatic colon cancer that's not spread and has specific molecular features (pMMR). They must be able to follow the study plan, have certain high-risk factors like large tumors or signs of spreading to lymph nodes, and be in good physical condition. People can't join if they've had severe lung disease, recent heart issues, major surgery within a month, active infections including TB or hepatitis B/C/HIV, received live vaccines recently, are pregnant/breastfeeding or planning pregnancy soon.
What is being tested?
The trial tests neoadjuvant CAPEOX chemotherapy combined with Atezolizumab (an immunotherapy drug) before surgery followed by more chemo if needed. It aims to see if this treatment shrinks tumors better and improves immune response. Patients get four cycles of both drugs every three weeks pre-surgery; high-risk patients may receive additional chemo post-surgery based on guidelines.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used (Atezolizumab/CAPEOX), risk of infection due to weakened immune system from chemotherapy and immunotherapy agents. Other common side effects might involve fatigue, digestive issues such as nausea/vomiting/diarrhea from chemo and potential liver function changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine the rate of complete histopathologic response to neoadjuvant immunotherapy with neoadjuvant chemotherapy in pMMR resectable, non-metastatic colon cancer.
Secondary study objectives
Assess short and long-term quality of life through Patient-Reported Outcomes (PROs)
Determine the R0 resection rate and number of lymph nodes harvested after neoadjuvant combination CAPEOX / Atezolizumab
Determine the relapse-free survival, time to recurrence, and overall survival after CAPEOX / Atezolizumab, and surgical resection.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Therapy ArmExperimental Treatment3 Interventions
Subjects will receive 4 cycles of neoadjuvant atezolizumab in combination with 4 cycles of CAPEOX before standard of care surgical resection. After surgery, patients who are still considered high risk for recurrence (per the treating medical oncologist) will be offered adjuvant therapy. Adjuvant therapy will consist of mFOLFOX6 Q2 weeks x 6 cycles (12 weeks) or CAPEOX Q3 weeks x 4 cycles (12 weeks).
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Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,970 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,132 Total Patients Enrolled
Atif Iqbal, MDPrincipal InvestigatorBaylor College of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major heart problems in the last 3 months.I have not had a severe infection in the last 4 weeks.I have not had major surgery in the last 4 weeks.I have high calcium levels in my blood that are causing symptoms.I have fluid buildup due to cancer spread in my chest or abdomen.I have not taken any strong antibiotics in the last 2 weeks.I have active tuberculosis.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I don't have any health issues that would prevent me from taking a new drug.I have had a previous transplant of stem cells or an organ.My cancer is spreading and causing symptoms or getting worse without treatment.I am currently on medication for hepatitis B.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I have had leptomeningeal disease.My tumor is located more than 12 cm from the anal opening, based on tests or surgery.I have a history of specific lung conditions not caused by known factors.I haven't taken any immune-weakening drugs in the last 2 weeks.I am over 18 years old.I am allergic to components in CAPEOX or mFOLFOX6 chemotherapy.My tumor is not MSI-high as determined by specific tests.My colon cancer is confirmed and can be surgically removed.I have not had any cancer other than colon adenocarcinoma in the last 5 years.I have or had an autoimmune disease or immune deficiency.I can provide a sample of my tumor for testing.My cancer pain is under control with a stable pain medication plan.I have not received a live vaccine in the last 4 weeks.I have one or more high-risk cancer features like high CEA, poor tumor grade, or large tumor size.My recent blood and organ function tests meet the study's requirements.I have or had more than one primary cancer in my colon or rectum.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Therapy Arm
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.