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Trial record 2 of 2 for:    CV9202

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

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ClinicalTrials.gov Identifier: NCT03164772
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : July 25, 2019
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

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).


Condition or disease Intervention/treatment Phase
Metastatic Non-small Cell Lung Cancer NSCLC Drug: Durvalumab Drug: Tremelimumab Biological: BI 1361849 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
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).
Drug: Durvalumab
anti-PD-L1
Other Name: MEDI4736

Biological: BI 1361849
mRNA Vaccine
Other Name: CV9202

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.

Drug: Durvalumab
anti-PD-L1
Other Name: MEDI4736

Drug: Tremelimumab
anti-CTLA-4

Biological: BI 1361849
mRNA Vaccine
Other Name: CV9202




Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: up to 15 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 24 weeks ]
    Objective Response Rate at 8 and 24 Weeks

  2. Progression Free Survival (PFS) [ Time Frame: 24 weeks ]
    Progression Free Survival (PFS) at 8 and 24 weeks

  3. Duration of Response (DoR) [ Time Frame: up to 15 months ]
  4. Overall Survival (OS) [ Time Frame: up to 5 years ]


Information from the National Library of Medicine

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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

  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.

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): NCT03164772


Contacts
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Contact: Andrew Park 212-450-1515 clintrialinformation@licr.org

Locations
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United States, Alabama
Research Facility Not yet recruiting
Huntsville, Alabama, United States, 35805
United States, Arizona
Research Facility Recruiting
Gilbert, Arizona, United States, 85234
United States, Florida
Research Facility Recruiting
Tampa, Florida, United States, 33612
United States, New York
Research Facility Recruiting
New York, New York, United States, 10016
United States, Wisconsin
Research Facility Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Cancer Research Institute, New York City
Boehringer Ingelheim
MedImmune LLC
CureVac AG
PharmaJet, Inc.
Investigators
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Study Chair: Jhanelle Gray, MD H. Lee Moffitt Cancer Center and Research Institute

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Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT03164772     History of Changes
Other Study ID Numbers: LUD2014-012-VAC
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ludwig Institute for Cancer Research:
mRNA Vaccine
Durvalumab
MEDI4736
anti-PD-L1
tremelimumab
anti-CTLA-4
BI 1361849
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Durvalumab
Tremelimumab
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents