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

Part of paid clinical trials in Port Orange, Florida.

Sponsor
Vaccinogen Inc
Study ID
NCT02448173
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Stage II Colon Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OncoVAX and Surgery — BIOLOGICAL
    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
    Surgical resection of Stage II colon cancer

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2033

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OncoVAX and Surgery
    Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer
  • Active Comparator: Surgery
    Surgical resection of Stage II colon cancer

Primary Outcome Measure

Disease-Free Survival [ Time Frame: Up to Five years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Halifax Health Medical CenterPort OrangeFlorida32127
Ammar Hemaidan, MD
Ammar Hemaidan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Port Orange, FL

By research site
Halifax Health Medical Center· Port Orange, FL

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