Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03164772 |
Recruitment Status :
Completed
First Posted : May 24, 2017
Last Update Posted : November 16, 2021
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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]
The run-in evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (inclusive of subjects from the run-in).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Non-small Cell Lung Cancer NSCLC | Drug: Durvalumab Drug: Tremelimumab Biological: BI 1361849 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 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 |
Actual Primary Completion Date : | October 29, 2021 |
Actual Study Completion Date : | October 29, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
The run-in dose evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (including subjects from the run-in).
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Drug: Durvalumab
anti-PD-L1
Other Name: MEDI4736 Biological: BI 1361849 mRNA Vaccine
Other Name: CV9202 |
Experimental: Arm B
The run-in dose evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (including subjects from the run-in).
|
Drug: Durvalumab
anti-PD-L1
Other Name: MEDI4736 Drug: Tremelimumab anti-CTLA-4 Biological: BI 1361849 mRNA Vaccine
Other Name: CV9202 |
- Number of Adverse Events [ Time Frame: up to 15 months ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- 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.
- Availability of archival (diagnostic) specimens or willing to undergo a pre-treatment biopsy.
- 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.
- Laboratory parameters for vital functions should be in the normal range.
- ECOG Performance Status ≤ 2.
Exclusion Criteria
Subjects 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.
- Subjects 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.

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
United States, Arizona | |
Research Facility | |
Gilbert, Arizona, United States, 85234 | |
United States, Florida | |
Research Facility | |
Tampa, Florida, United States, 33612 | |
United States, Michigan | |
Research Facility | |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Research Facility | |
New York, New York, United States, 10016 | |
United States, Wisconsin | |
Research Facility | |
Milwaukee, Wisconsin, United States, 53226 |
Study Chair: | Jhanelle Gray, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT03164772 |
Other Study ID Numbers: |
LUD2014-012-VAC |
First Posted: | May 24, 2017 Key Record Dates |
Last Update Posted: | November 16, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
mRNA Vaccine Durvalumab MEDI4736 anti-PD-L1 |
tremelimumab anti-CTLA-4 BI 1361849 |
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 Antineoplastic Agents, Immunological Antineoplastic Agents |