Moffitt logo

Clinical Trials Search

Clinical Trial 20363

Cancer Type: Immunotherapy
Study Type: Treatment
NCT#: NCT04069936

Phase: Phase II
Prinicipal Investigator:

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

A Phase 2a, Open-Label, Multi-Center Study to Assess the Efficacy and Safety of Marrow Infiltrating Lymphocytes NonSmall Cell Lung Cancer (MILs - SCLC) Alone or in Combination with Nivolumab in Subjects with Locally Advanced and Unresectable or Metastatic NSCLC Previously Treated with Anti-PD-1

Summary

The purpose of this study is to determine the safety and efficacy of MILs™ - NSCLC alone and in combination with nivolumab in subjects with locally advanced and unresectable or metastatic NSCLC who are refractory or relapsing to a PD-1 containing regimen.

Objective

Primary: -To assess the safety of MILs - NSCLC alone in subjects with advanced unresectable or metastatic NSCLC -To asses the safety of MILs - NSCLC in combination with pembrolizumab per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects with advanced unresectable or metastatic NSCLC Secondary" -to further assess the efficacy of MILs - NSCLC in combination with pembrolizumab in subjects with advanced unresectable or metastatic NSCLC: -duration of response (DOR) -disease control rate (DCR) -PFS -OS -to determine the safety and tolerability of MILs - NSCLC in combination with pembrolizumab in subjects with advanced unresectable or metastatic NSCLC Exploratory: -To assess the relationship between tumor biomarkers and efficacy parameters of MILs - NSCLC in combination with pembrolizumab in subjects with unresectable or metastatic NSCLC -To explore the relationship between the immune composition of the MILs - NSCLC preparation and efficacy parameters in subjects with advanced unresectable or metastatic NSCLC -To explore the relationship between the immune effects of the administration of MILs - NSCLC in combination with pembrolizumab and efficacy parameters in subjects with advanced unresectable or metastatic NSCLC

Treatments

Therapies

Medications

BMS-936558 (Nivolumab); MILs - NSCLC (); Nivolumab (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Locally advanced and unresectable, or metastatic NSCLC.
  • Histologically or cytologically confirmed, either squamous or non-squamous NSCLC.
  • Measurable disease as per RECIST 1.1 with radiographic evidence of disease progression.
  • Willingness to undergo bone marrow aspiration (BMA).
  • No more than one treatment regimen following an anti-PD-1 antibody containing treatment regimen prior to BMA collection
  • 21 days or more have lapsed since last cytotoxic chemotherapy treatment prior to collection of the BMA.
  • Previous treatment with the appropriate targeted therapy if the subject has known EGFR/ALK/ROS1 rearrangements.
  • Willingness to provide a fresh tumor biopsy during Screening Period or formalin-fixed, paraffin-embedded tissue collected at the time of most recent relapse. Note: Archival tissue regardless of biopsy date may be considered.
  • Adequate renal, hepatic and bone marrow function as defined per protocol.
  • Women of childbearing potential and male subjects (even if they are surgically sterilized or had a vasectomy) and their partners must agree to abstain or to use an effective form of birth control during the study for at least 6 months following administration of the last dose of lymphodepletion or for at least 5 months following the last dose of nivolumab for females and 7 months for males, whichever is longer. In addition, male subjects must not donate sperm during this period.
  • Capable of giving and has provided a signed ICF, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

  • Exclusion Criteria

  • Insufficient activation/expansion of T cells or other problems with the subject's MILs™ - NSCLC product which would prohibit administration.
  • Major surgical procedure within 7 days of the first dose of lymphodepletion treatment.
  • Prior malignancy active within the previous 3 years from date of BMA collection except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Subjects with symptomatic uncontrolled brain metastases requiring treatment with steroids or anti-seizure medications within 28 days prior to the BMA are excluded. However, participants with brain metastases that have been previously treated and are stable on subsequent scan(s) are allowed and subjects with untreated possible brain metastases that are new at the time of screening and are less than 1 cm and asymptomatic are allowed.
  • Infection requiring treatment with intravenous antibiotics, antifungal, or antiviral agents within 7 days prior to the BMA.
  • Presence of an autoimmune disease requiring active systemic treatment.
  • Clinically significant, uncontrolled cardiovascular disease, including congestive heart failure Grade III or IV according to the New York Heart Association classification, myocardial infarction or unstable angina within the previous 6 months prior to BMA collection.
  • Known diagnosis of human immunodeficiency virus (HIV) or active viral hepatitis.
  • Administration of neutrophil growth factor support within 14 days prior to the BMA.
  • Use of systemic corticosteroids (glucocorticoids) for greater than one day within 28 days prior to the BMA.
  • Planned use of systemic corticosteroids (glucocorticoids) for greater than one day within 28 days prior to MILs™ - NSCLC administration.
  • Prior radiation to both sides of the pelvis. Prior radiation to one side of the pelvis is permitted as long as the other side of the pelvis.
  • Subjects with history of life-threatening toxicity related to prior immune therapy except those that are unlikely to re-occur with standard countermeasures.
  • Receipt of live attenuated vaccine within 30 days of planned Day 0.
  • History of allergy or hypersensitivity to MILs™-NSCLC, cyclophosphamide, fludarabine, nivolumab or their components.
  • Pregnant or lactating females.
  • Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject or impair the assessment of study results.
  • Unwilling or unable to comply with the protocol.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.