Lung Cancer Clinical Trial
Official title:
A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
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.
This study has two parts and participants may be involved in either Phase I part or Phase II.
Phase I: Investigators plan to enroll participants in cohorts of 6 and monitor side effects
over a 21 day period to determine the maximum tolerated dose (MTD) of nivolumab, which will
be given in combination with GM.CD40L. This is being done since this study involves a
combination of treatments that have not been studied in humans before and to find the best
dose for the Phase II part of the study.
Phase II: Investigators plan to compare any clinical benefit in the participants who receive
the combination of GM.CD40L vaccine with nivolumab, to participants that receive only
nivolumab.
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