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Cancer Vaccine

EGF-Depleting Vaccine + Standard Therapy for Colorectal Cancer

Q: Is there presently an opportunity to join this research?

<p>According to clinicaltrials.gov, this medical trial is currently open for enrollment and was posted on November 2nd 2023 with its most recent update being October 30th of the same year.</p>

Q: What is the approximate size of this scientific investigation?

<p>Affirmative. Clinicaltrials.gov documents that this trial has been open for recruitment since November 2nd 2023 and was last amended on October 30th 2023, with a total of 42 enrollees sought from 1 medical site.</p>

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 time from treatment until disease progression, death or last follow up assesed up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ time from treatment until disease progression, death or last follow up assesed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from treatment until disease progression, death or last follow up assesed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from treatment until disease progression, death or last follow up assesed up to 2 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

Immunogencity of vaccine

Secondary outcome measures

Progression free survival

Trial Design

4Treatment 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 AExperimental 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 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

Oxaliplatin

2011

Completed Phase 4

~2560

Bevacizumab

2013

Completed Phase 4

~5280

Metastasectomy

2010

N/A

~100

Irinotecan

2017

Completed Phase 4

~2680

Leucovorin

2005

Completed Phase 4

~5730

Biospecimen collection

2020

N/A

~70

Fluorouracil

2014

Completed Phase 3

~11540

Cetuximab

2011

Completed Phase 3

~2480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,765 Total Patients Enrolled

Deepak VadehraPrincipal InvestigatorRoswell Park Comprehensive Cancer Center

Frequently Asked Questions

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

Is there presently an opportunity to join this research?

"According to clinicaltrials.gov, this medical trial is currently open for enrollment and was posted on November 2nd 2023 with its most recent update being October 30th of the same year."

Answered by AI

What is the approximate size of this scientific investigation?

"Affirmative. Clinicaltrials.gov documents that this trial has been open for recruitment since November 2nd 2023 and was last amended on October 30th 2023, with a total of 42 enrollees sought from 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer

2023. "EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011772.