CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 80 enrolled
Drug / intervention
Nivolumab 240 MGdrug
Likely dose
Nivolumab 240 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04021108
NCT04021108Phase 2Active

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)

Weill Medical College of Cornell University·interventional·Posted Jul 16, 2019·Updated Jun 24, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab 240 MG for Gastroesophageal Adenocarcinoma. Active but no longer recruiting, targeting 80 participants across 5 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2ActiveOverdue
2020202120222023202420252026
First PostedJul 16, 2019
Enrollment StartJul 22, 2019
Primary CompletionJun 11, 2025
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 7.0 years ago

Interventions

Nivolumab 240 MGdrug

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.