Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L)

Part of paid clinical trials in Tampa, Florida.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04021108
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Gastroesophageal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab 240 MG — DRUG
    Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.

Study Details

This is a randomized phase II study examining nivolumab alone versus radiation therapy with nivolumab in subjects who did not have disease progression to initial therapy with the combination of FOLFOX and Nivolumab.

Key Dates

Start date
Jul 22, 2019
Status verified
Jun 2025
Primary completion
Jun 11, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Cohort 1
    Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2. Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
  • Experimental: Cohort 2
    Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2. Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)

Primary Outcome Measure

Number of patients with 12-month progression free survival [ Time Frame: 12 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Washington University School of MedicineSt LouisMissouri63110-
University of NebraskaOmahaNebraska68105-
Roswell Park Cancer CenterBuffaloNew York14203-
Weill Cornell MedicineNew YorkNew York10065-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLWashington University School of Medicine· St Louis, MOUniversity of Nebraska· Omaha, NERoswell Park Cancer Center· Buffalo, NYWeill Cornell Medicine· New York, NY

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