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Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164772
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : February 19, 2020
Sponsor:
Collaborators:
Cancer Research Institute, New York City
Boehringer Ingelheim
MedImmune LLC
CureVac AG
PharmaJet, Inc.
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Tracking Information
First Submitted Date  ICMJE May 22, 2017
First Posted Date  ICMJE May 24, 2017
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE December 20, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
Number of Adverse Events [ Time Frame: up to 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • Objective Response Rate (ORR) [ Time Frame: up to 24 weeks ]
    Objective Response Rate at 8 and 24 Weeks
  • Progression Free Survival (PFS) [ Time Frame: 24 weeks ]
    Progression Free Survival (PFS) at 8 and 24 weeks
  • Duration of Response (DoR) [ Time Frame: up to 15 months ]
  • Overall Survival (OS) [ Time Frame: up to 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC
Official Title  ICMJE A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With Non-small Cell Lung Cancer (NSCLC)
Brief 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.

Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 [durvalumab] Arm B: mRNA Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 [tremelimumab]

For each arm of the study, there is a dose evaluation phase in which the Recommended Combination Dose (RCD) is determined according to a standard 3 + 3 design. The dose evaluation phase is followed by an expansion phase, in which the cohort at the RCD is expanded to 20 subjects (inclusive of the subjects from the dose evaluation cohort).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Non-small Cell Lung Cancer
  • NSCLC
Intervention  ICMJE
  • Drug: Durvalumab
    anti-PD-L1
    Other Name: MEDI4736
  • Drug: Tremelimumab
    anti-CTLA-4
  • Biological: BI 1361849
    mRNA Vaccine
    Other Name: CV9202
Study Arms  ICMJE
  • Experimental: Arm A
    There is a dose evaluation phase in which the Recommended Combination Dose is determined according to a standard 3 + 3 design. The dose evaluation phase is followed by an expansion phase, in which the cohort at the Recommended Combination Dose is expanded to 20 subjects (inclusive of the subjects from the dose evaluation cohort).
    Interventions:
    • Drug: Durvalumab
    • Biological: BI 1361849
  • Experimental: Arm B

    The dose evaluation phase is followed by an expansion phase, in which the cohort at the Recommended Combination Dose is expanded to 20 subjects (inclusive of the subjects from the dose evaluation cohort).

    For Arm B, there will be an additional Control group (n = 10) added to the expansion phase in which the subjects will receive only durvalumab and tremelimumab every 4 weeks.

    Interventions:
    • Drug: Durvalumab
    • Drug: Tremelimumab
    • Biological: BI 1361849
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Histologic confirmation of metastatic NSCLC. For subjects with known EGFR or ALK/ROS-1 mutations, prior therapy must have included an EGFR tyrosine kinase inhibitor or ALK/ROS-1 inhibitor, respectively. Subjects may have had 1 prior line of anti-PD-1/PD-L1 therapy. Subjects who received prior anti-PD-1/PD-L1 therapy must have progressed during or after treatment, but not prior to Week 12 of treatment.
  2. Availability of archival (diagnostic) specimens or willing to undergo a pre-treatment biopsy.
  3. Subjects 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.
  4. Laboratory parameters for vital functions should be in the normal range.
  5. ECOG Performance Status ≤ 2.

Exclusion Criteria

Subjects may not enter the study if they fulfill any of the following criteria:

  1. Treatment with an investigational agent within 4 weeks of starting treatment or prior treatment with anti-CTLA-4 therapy.
  2. Active, suspected or prior documented autoimmune disease, clinically significant cardiovascular disease, or clinically uncontrolled hypertension.
  3. History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events following prior therapy.
  4. 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.
  5. Subjects who are immunosuppressed, including those with known immunodeficiency or have active infection including tuberculosis or other serious illnesses.
  6. Skin disease (e.g., psoriasis) that may prevent intradermal administration of the vaccine into the target areas.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew Park 212-450-1515 clintrialinformation@licr.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164772
Other Study ID Numbers  ICMJE LUD2014-012-VAC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ludwig Institute for Cancer Research
Study Sponsor  ICMJE Ludwig Institute for Cancer Research
Collaborators  ICMJE
  • Cancer Research Institute, New York City
  • Boehringer Ingelheim
  • MedImmune LLC
  • CureVac AG
  • PharmaJet, Inc.
Investigators  ICMJE
Study Chair: Jhanelle Gray, MD H. Lee Moffitt Cancer Center and Research Institute
PRS Account Ludwig Institute for Cancer Research
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP