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Trial record 29 of 322 for:    "Adenocarcinoma of lung"

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

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ClinicalTrials.gov Identifier: NCT02466568
Recruitment Status : Withdrawn (Funding unavailable)
First Posted : June 9, 2015
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Adenocarcinoma of the Lung Drug: Nivolumab Biological: GM.CD40L Vaccine Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
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.
Drug: Nivolumab
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.
Other Names:
  • Opdivo
  • Anti-PD-1

Biological: GM.CD40L Vaccine
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.
Other Names:
  • Immunotherapy
  • Cell Vaccine

Active Comparator: Phase II Control Arm
Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.
Drug: Nivolumab
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.
Other Names:
  • Opdivo
  • Anti-PD-1




Primary Outcome Measures :
  1. Phase I: Recommended Phase II Dose [ Time Frame: Up to 2 months ]
    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.

  2. Phase II: Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]
    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 :
  1. Phase II: Overall Survival (OS) [ Time Frame: Up to 2 years ]
    OS per treatment arm. Overall survival is defined as the time from randomization until death from any cause.

  2. Phase II: Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]
    PFS per treatment arm. Progressive Disease (PD): = 20% increase in the sum of the longest diameter of target lesions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466568


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

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02466568     History of Changes
Other Study ID Numbers: MCC-18147
1504-1392 ( Other Identifier: NIH Office of Biotechnology Activities (OBA) )
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
advanced
metastatic
lung disease
adenocarcinoma
non-small cell lung cancer (NSCLC)

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Vaccines
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents