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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/2/2019
Start Date:December 20, 2017
End Date:December 2024
Contact:Andrew Park
Email:clintrialinformation@licr.org
Phone:212-450-1515

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

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).


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.
We found this trial at
4
sites
Gilbert, Arizona 85234
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Gilbert, AZ
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600 East Greenfield Avenue
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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3840 Corlear Avenue
New York, New York 10065
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New York, NY
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4202 East Fowler Avenue
Tampa, Florida 33612
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Tampa, FL
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