REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03610711
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Gastroesophageal Cancer
  • Immune Checkpoint Inhibition

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    240mg administered IV over 30 minutes every 2 weeks for one year
  • Relatlimab — DRUG
    every 2 weeks for one year

Study Details

This is a Phase 1B study assessing the safety of immune checkpoint inhibition after SBRT in patients with recurrent or metastatic gastroesophageal cancer (limited metastatic disease).

Key Dates

Start date
Mar 6, 2019
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A Nivolumab Only
    stereotactic body radiation (SBRT) 8G x 3 followed by Nivolumab 240mg administered IV over 30 minutes every 2 weeks for one year or until evidence of disease progression or unresolved toxicity.
  • Experimental: Arm B Nivolumab + Relatlimab
    stereotactic body radiation (SBRT) 8G x 3 followed by Nivolumab 240mg administered IV over 30 minutes every 2 weeks and Relatlimab (anti-LAG3) every 2 weeks for one year or until evidence of disease progression or unresolved toxicity.

Primary Outcome Measure

Change in the infiltrating CD8+ T cell density units after systemic treatment with radiation plus nivolumab +/- Relatlimib [ Time Frame: 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-
Alleghany Health NetworkPittsburghPennsylvania15212-
Baylor UniversityDallasTexas75246-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University· Baltimore, MDAlleghany Health Network· Pittsburgh, PABaylor University· Dallas, TX

Related Studies