Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03044613
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    240mg or 1 mg/kg administered IV
  • Relatlimab — DRUG
    80mg administered IV
  • Carboplatin — DRUG
    standard care dose
  • Paclitaxel — DRUG
    standard care dose
  • Radiation — RADIATION
    standard care dose

Study Details

Anti-PD-1 (nivolumab) or Anti-PD1/Anti LAG-3- (relaltimab) administration in the pre-operative setting with chemoradiation will be safe and feasible in patients with resectable distal esophageal/gastroesophageal junction cancer and will change cellular and molecular characteristics of the tumor microenvironment that will improve survival.

Key Dates

Start date
Jul 11, 2017
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Nivolumab 240mg administered IV over 30 minutes every 2 weeks for 2 cycles and then standard of care chemoradiation (weekly carboplatin/paclitaxel and concurrent radiation
  • Experimental: Arm B
    Nivolumab 240mg administered IV over 30 minutes followed by relatlimab 80mg administered IV over 60 minutes on Day 1 every 2 weeks for 2 cycles and then standard of care chemoradiation (weekly carboplatin/paclitaxel and concurrent radiation).

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 100 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-
Alleghany Health NetworkPittsburghPennsylvania15212-
Baylor University/ Charles A. Sammons Cancer CenterDallasTexas75246-

Find similar trials in Baltimore, MD

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Johns Hopkins University· Baltimore, MDAlleghany Health Network· Pittsburgh, PABaylor University/ Charles A. Sammons Cancer Center· Dallas, TX

Related Studies