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Cancer Vaccine

EGF-Depleting Vaccine + Standard Therapy for Colorectal Cancer

Phase < 1

Recruiting

Led By Deepak Vadehra

Research Sponsored by Roswell Park Cancer Institute

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 up to 60 days after last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a vaccine can help treat colorectal cancer, when used with standard treatments.

Who is the study for?

This trial is for adults with metastatic colorectal cancer that hasn't spread to the brain, who haven't had certain treatments or surgeries recently. They should have a type of cancer not affected by RAS/BRAF mutations and be in good physical condition. Participants must not have other active cancers, serious heart conditions, uncontrolled high blood pressure, significant infections, or immune diseases like HIV.

What is being tested?

The study tests CIMAvax-EGF vaccine's ability to trigger an anti-cancer immune response when combined with standard therapies (like chemotherapy and biological agents) in patients with specific types of advanced colorectal cancer. It aims to see if this combination can improve treatment outcomes.

What are the potential side effects?

Possible side effects include reactions at the injection site from the vaccine, typical chemotherapy-related issues such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding tendencies. There may also be risks associated with immunotherapy like allergic reactions or autoimmune-like symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immunogencity of vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment6 Interventions

Description LOADING PHASE: Patients receive CIMAvax-EGF IM on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive mFOLFOX6 and cetuximab, FOLFOX6 and bevacizumab, or mFOLFOX6 per investigators preference. Treatment repeats every 2 weeks for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo metastasectomy 4-8 weeks after first maintenance phase dose. Patients undergo collection of blood samples throughout the trial.

Group II: Cohort B2Experimental Treatment5 Interventions

LOADING PHASE: Patients receive CIMAvax-EGF IM on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive mFOLFOX6 chemotherapy and cetuximab IV over 120 minutes on days 1 and 15. Treatment repeats every 2 weeks for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples throughout the trial

Group III: Cohort B1Experimental Treatment6 Interventions

LOADING PHASE: Patients receive CIMAvax-EGF IM on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive FOLFIRI consisting of irinotecan IV, leucovorin IV over 90 minutes, and fluorouracil IV and cetuximab IV over 120 minutes on days 1 and 15. Treatment repeats every 2 weeks for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples throughout the trial.

Group IV: Cohort A2Experimental Treatment6 Interventions

LOADING PHASE: Patients receive CIMAvax-EGF intramuscularly (IM) on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive mFOLFOX6 chemotherapy consisting of leucovorin IV, oxaliplatin IV over 2 hours, and fluorouracil IV, as well as cetuximab IV over 120 minutes on days 1 and 15, or panitumumab IV over 60 minutes on days 1 and 15. Patients undergo collection of blood samples and CT throught the trial

Group V: Cohort A1Experimental Treatment6 Interventions

LOADING PHASE: Patients receive CIMAvax-EGF IM on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive mFOLFOX6 chemotherapy consisting of leucovorin IV, oxaliplatin IV over 2 hours, and fluorouracil IV and bevacizumab IV over 10 minutes on days 1 and 15. Treatment repeats every 2 weeks for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Oxaliplatin

2011

Completed Phase 4

~2890