Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02466568
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Participants will receive treatment with nivolumab as a 60-minute +/-5 minutes intravenous (IV) infusion on Day 1 and 15 of each 28-day cycle.
  • GM.CD40L Vaccine — BIOLOGICAL
    GM.CD40L will be injected intradermally every 2 weeks for 4 injections, then every month for 4 injections, then every 3 months until the patient is off treatment.

Study Details

The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.

Key Dates

Start date
Jul 31, 2018
Status verified
Sep 2019
Primary completion
Jul 31, 2019
Completion
Jul 31, 2020

Study Design

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

Arms

  • Experimental: Phase I and Phase II Treatment Arm
    Participants will receive nivolumab and GM.CD40L. Treatment will be administered on an outpatient basis. The nivolumab will be given first followed by the GM.CD40L vaccine for those enrolled on this arm.
  • Active Comparator: Phase II Control Arm
    Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.

Primary Outcome Measure

Phase I: Recommended Phase II Dose [ Time Frame: Up to 2 months ]

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