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

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Adenocarcinoma of lung
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Boehringer Ingelheim – Adenocarcinoma of lung
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Brief Title

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

Official Title

A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung

Brief Summary

      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.

Detailed Description

      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.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Phase I: Recommended Phase II Dose

Secondary Outcome

 Phase II: Overall Survival (OS)

Condition

Lung Cancer

Intervention

Nivolumab

Study Arms / Comparison Groups

 Phase I and Phase II Treatment Arm
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

July 2018

Completion Date

July 2020

Primary Completion Date

July 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0/1

          -  Chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung
             cancer (NSCLC) >6 months prior

          -  Adequate bone marrow, renal and hepatic function

          -  Must have measurable metastatic disease according to Response Evaluation Criteria in
             Solid Tumors (RECIST) v1.1 criteria

          -  Mandatory archival tissue or willingness to undergo a fresh biopsy

          -  Life expectancy of greater than 6 months

        Exclusion Criteria:

          -  Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis

          -  Pregnancy or breast feeding

          -  Serious uncontrolled medical disorder or active infection that would impair the
             participant's ability to receive study treatment

          -  Prior use of a PD1 or PDL1 inhibitor

          -  Concurrent use of other anticancer approved or investigational agents is not allowed

          -  Autoimmune disorders

          -  Prior malignancy in past 2 years

          -  Systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent

          -  Any other pre-existing immunodeficiency condition (including known HIV infection)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jhanelle Gray, M.D., ,

Administrative Informations

NCT ID

NCT02466568

Organization ID

MCC-18147

Secondary IDs

1504-1392

Responsible Party

Sponsor

Study Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Study Sponsor

Jhanelle Gray, M.D., Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute

Verification Date

September 2019