OncoVAX for Colon Cancer

Overseen By Michael G Hanna, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vaccinogen Inc

Disqualifiers: Prior radiation, chemotherapy, prior malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests OncoVAX®, a new treatment aimed at preventing the return of Stage II colon cancer after surgery. OncoVAX® uses a patient's own cancer cells to help the immune system target any remaining cancer cells. The study compares patients who receive only surgery to those who receive both surgery and OncoVAX®. Candidates may qualify if they have had Stage II colon cancer removed and recent check-ups show no signs of cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the OncoVAX trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that OncoVAX has been tested in several studies involving people with colon cancer. These studies found positive results for those with stage II colon cancer. The treatment uses a person's own cancer cells to help the body fight the cancer and prevent its return after surgery.

Safety information from earlier research suggests that OncoVAX is generally well-tolerated. Some studies noted that patients who had an immune response to the vaccine experienced better outcomes, meaning their condition improved when their body reacted well to the treatment.

While OncoVAX remains under investigation, these findings suggest it might be safe for use. However, as it is still in the trial phase, some risks may not yet be fully understood. Always discuss potential risks and benefits with a healthcare provider before joining any clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment for Stage II colon cancer, which typically involves surgical resection, OncoVAX introduces an innovative approach by combining surgery with autologous specific immunotherapy. This immunotherapy is derived from the patient’s own tumor cells, which are then used to stimulate the immune system to specifically target and attack any remaining cancer cells. Researchers are excited about OncoVAX because it has the potential to improve the body’s natural ability to fight cancer, reducing the risk of recurrence and enhancing long-term survival rates.

What evidence suggests that OncoVAX® might be an effective treatment for Stage II colon cancer?

Research shows that OncoVAX, a vaccine made from a patient's own tumor cells, has promising results for people with Stage II colon cancer. In this trial, some participants will receive OncoVAX alongside surgery. Studies have found that this vaccine helps the immune system identify and attack cancer cells, reducing the chance of cancer returning after surgery. Clinical trials demonstrated that OncoVAX significantly helps prevent cancer recurrence. Specifically, patients who received OncoVAX had better survival rates than those who only underwent surgery. These findings suggest that OncoVAX could be an effective new treatment for Stage II colon cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Herbert C. Hoover, MD

Principal Investigator

Vaccinogen Inc

Michael G Hanna, Jr, PhD

Principal Investigator

Vaccinogen Inc

Are You a Good Fit for This Trial?

This trial is for patients with Stage II colon cancer who've had surgery to remove it and show no signs of remaining or spread disease. They must have normal CEA levels, a tumor marker, after surgery to join.

Inclusion Criteria

My cancer is at Stage II.

I had surgery to remove my cancer and there's no sign of cancer left.

My CEA levels returned to normal after surgery within 21 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Standard-of-care surgical tumor resection for Stage II colon cancer

1 week

Treatment

Participants receive three weekly injections of OncoVAX followed by a booster shot after six months

6 months

3 visits (in-person) for initial injections, 1 visit (in-person) for booster

Follow-up

Participants are monitored for disease recurrence and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• OncoVAX®
• Surgery

Trial Overview

The study tests OncoVAX, a personalized vaccine made from the patient's own cancer cells, aimed at preventing cancer return post-surgery in Stage II colon cancer patients compared to those only receiving surgery.

How Is the Trial Designed?

Group I: OncoVAX and Surgery Experimental Treatment 2 Interventions

Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer

Group II: Surgery Active Control 1 Intervention

Surgical resection of Stage II colon cancer

Who Is Running the Clinical Trial?

Vaccinogen Inc

Lead Sponsor

Trials

1

Recruited

550+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0264410X00004850

Adjuvant active specific immunotherapy of stage II and ...

Active specific immunotherapy (ASI) with autologous tumor cell vaccines has resulted in significant beneficial outcomes in patients with stage II colon cancer.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3551893/

Immunotherapy with autologous tumor cell vaccines for ...

Several phase I/II dose optimization and regimen finding clinical trials were performed with OncoVAX, in stage II and III colon cancer patients. In the 1980s ...

3.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(19)46043-2/fulltext

Adjuvant therapy for stage II colon cancer: an elephant in ...

Conversely, the NSABP group performed a pooled analysis of outcome data from four of their trials (C-01 to C-04) with >1500 stage II patients. They compared ...

4.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1427428/full

Efficacy of novel allogeneic cancer cells vaccine to treat ...

The first trial of the autologous whole cell-based vaccine called ONCOVAX showed interesting results in patients with stage II colon cancer (13) ...

5.

cancernetwork.com

cancernetwork.com/view/new-cancer-vaccine-appears-improve-colon-cancer-survival

New Cancer Vaccine Appears to Improve Colon ...

“If approved by FDA, the OncoVAX vaccine therapy will be a completely new treatment approach that could become standard treatment for stage II colon cancer, ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02448173

NCT02448173 | A Multicenter Study of Active Specific ...

OncoVAX is designed to use a patient's own cancer cells to mobilize the body's immune system to prevent the return of colon cancer following surgery.

7.

bmjopen.bmj.com

bmjopen.bmj.com/content/10/6/e034714

Safety and efficacy of autologous tumour cell vaccines as a ...

Evidence suggests that among patients receiving these vaccines, those who mount an immune response against their own tumour cells have better prognosis, and a ...