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Clinical Trial 19569

Cancer Type: Thoracic
Interventions:

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Jhanelle Gray

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

Study Title

A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects with Non-small Cell Lung Cancer (NSCLC)

Summary

Objective

Inclusion Criteria

  • Histologic confirmation of metastatic NSCLC. For Participants with known EGFR or ALK/ROS-1 mutations, prior therapy must have included an EGFR tyrosine kinase inhibitor or ALK/ROS-1 inhibitor, respectively. Participants may have had 1 prior line of anti-PD-1/PD-L1 therapy. Participants who received prior anti-PD-1/PD-L1 therapy must have progressed during or after treatment, but not prior to Week 12 of treatment.
  • Availability of archival (diagnostic) specimens or willing to undergo a pre-treatment biopsy.
  • Participants with treated brain metastases must have been treated with surgery and/or radiation therapy ≥ 21 days pre-study and must be clinically stable with no requirement for steroids.
  • Laboratory parameters for vital functions should be in the normal range.
  • ECOG Performance Status ≤ 2.

  • Exclusion Criteria

  • Participants may not enter the study if they fulfill any of the following criteria:
  • Treatment with an investigational agent within 4 weeks of starting treatment or prior treatment with anti-CTLA-4 therapy.
  • Active, suspected or prior documented autoimmune disease, clinically significant cardiovascular disease, or clinically uncontrolled hypertension.
  • History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events following prior therapy.
  • Major surgery within 4 weeks of starting treatment (or scheduled for surgery during the projected course of the study) or prior cancer vaccine treatment or allogeneic bone marrow transplantation.
  • Participants who are immunosuppressed, including those with known immunodeficiency or have active infection including tuberculosis or other serious illnesses.
  • Skin disease (e.g., psoriasis) that may prevent intradermal administration of the vaccine into the target areas.