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Clinical Trial 19569

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03164772

Phase: Phase I/II
Prinicipal Investigator:

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Overview

Study Title

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

Summary

This is an open-label multicenter 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC

Objective

Primary Objective- Dose Evaluation Phase: Safety and Tolerability [CTCAE 4.03, including DLTs and RCD] Expansion Phase: Safety and Tolerability [CTCAE 4.03] Secondary Objectives- Dose Evaluation and Expansion Phases (all subjects): Clinical Efficacy by irRECIST and RECIST 1.1 [PFS rate and ORR at 8 and 24 weeks, best overall response, DCR, DoR, OS] Exploratory Objectives- Dose Evaluation and Expansion Phases (all subjects): Biologic Activity [Effects on Tumor Microenvironment, Immune Responses]

Treatments

Therapies

Medications

AMP-514 (Durvalumab); BI 1361849 (); CP-675,206 (tremelimumab); Durvalumab (); MEDI4736 (Durvalumab); tremelimumab ()

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.

  • 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.