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

Primary Purpose

Lung Cancer, Adenocarcinoma of the Lung

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nivolumab
GM.CD40L Vaccine
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring advanced, metastatic, lung disease, adenocarcinoma, non-small cell lung cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Phase I and Phase II Treatment Arm

    Phase II Control Arm

    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.

    Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.

    Outcomes

    Primary Outcome Measures

    Phase I: Recommended Phase II Dose
    The recommended Phase II dose will be defined as the highest dose level of GMCD40L vaccine in combination with nivolumab that induced dose limiting toxicity (DLT) in fewer than 33% of patients.
    Phase II: Objective Response Rate (ORR)
    Objective tumor response per treatment arm. ORR: Complete Response (CR) = disappearance of all target lesions + Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions.

    Secondary Outcome Measures

    Phase II: Overall Survival (OS)
    OS per treatment arm. Overall survival is defined as the time from randomization until death from any cause.
    Phase II: Progression-free Survival (PFS)
    PFS per treatment arm. Progressive Disease (PD): = 20% increase in the sum of the longest diameter of target lesions.

    Full Information

    First Posted
    June 5, 2015
    Last Updated
    September 6, 2019
    Sponsor
    H. Lee Moffitt Cancer Center and Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02466568
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding unavailable
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    H. Lee Moffitt Cancer Center and Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer, Adenocarcinoma of the Lung
    Keywords
    advanced, metastatic, lung disease, adenocarcinoma, non-small cell lung cancer (NSCLC)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase I and Phase II Treatment Arm
    Arm Type
    Experimental
    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.
    Arm Title
    Phase II Control Arm
    Arm Type
    Active Comparator
    Arm Description
    Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.
    Intervention Type
    Drug
    Intervention Name(s)
    Nivolumab
    Other Intervention Name(s)
    Opdivo, Anti-PD-1
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    GM.CD40L Vaccine
    Other Intervention Name(s)
    Immunotherapy, Cell Vaccine
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Phase I: Recommended Phase II Dose
    Description
    The recommended Phase II dose will be defined as the highest dose level of GMCD40L vaccine in combination with nivolumab that induced dose limiting toxicity (DLT) in fewer than 33% of patients.
    Time Frame
    Up to 2 months
    Title
    Phase II: Objective Response Rate (ORR)
    Description
    Objective tumor response per treatment arm. ORR: Complete Response (CR) = disappearance of all target lesions + Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions.
    Time Frame
    Up to 2 years
    Secondary Outcome Measure Information:
    Title
    Phase II: Overall Survival (OS)
    Description
    OS per treatment arm. Overall survival is defined as the time from randomization until death from any cause.
    Time Frame
    Up to 2 years
    Title
    Phase II: Progression-free Survival (PFS)
    Description
    PFS per treatment arm. Progressive Disease (PD): = 20% increase in the sum of the longest diameter of target lesions.
    Time Frame
    Up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jhanelle Gray, M.D.
    Organizational Affiliation
    H. Lee Moffitt Cancer Center and Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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