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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months for reporting.

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 more

Awards & 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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