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A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer

ConditionStage II Colon Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVaccinogen Inc

About this trial

OncoVAX® is the first cancer therapy that both prevents cancer recurrence and

addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase

IIIb study in patients with Stage II colon cancer, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have Stage II (IIA = T3N0M0, IIB = T4aN0M0, IIC = T4bN0M0) disease.

Patients must have undergone curative resection and have no evidence of residual or metastatic disease.

Following curative resection patients must have a CEA within normal limits. If elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization.

Disqualifiers

Patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. However, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study.

Patients with more than one malignant primary colon cancer will be excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • OncoVAX and Surgery

    Biological/Vaccine

    OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer

  • Surgery

    Procedure/Surgery

    Surgical resection of Stage II colon cancer

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: OncoVAX and SurgeryExperimental treatment 2 interventions
Group B: SurgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-Free Survival

Defined as time from randomization to the date of the first objective test confirming tumor recurrence or death due to any cause

Time frame
Up to Five years

Secondary outcomes

1

Overall Survival

Defined as the time from randomization to death due to any cause

Time frame
Up to Five Years
2

Recurrence-Free Interval

Defined as the time from randomization to the first objective test confirming tumor recurrence

Time frame
Up to Five Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vaccinogen Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: