Description:
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).
Title
- Brief Title: Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC
- Official Title: A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With Non-small Cell Lung Cancer (NSCLC)
Clinical Trial IDs
- ORG STUDY ID:
LUD2014-012-VAC
- NCT ID:
NCT03164772
Conditions
- Metastatic Non-small Cell Lung Cancer
- NSCLC
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | MEDI4736 | Arm A |
Tremelimumab | | Arm B |
BI 1361849 | CV9202 | Arm A |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | 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). | |
Arm B | Experimental | 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). | - Durvalumab
- Tremelimumab
- BI 1361849
|
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Adverse Events |
Time Frame: | up to 15 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | up to 24 weeks |
Safety Issue: | |
Description: | Objective Response Rate at 8 and 24 Weeks |
Measure: | Progression Free Survival (PFS) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | Progression Free Survival (PFS) at 8 and 24 weeks |
Measure: | Duration of Response (DoR) |
Time Frame: | up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Ludwig Institute for Cancer Research |
Trial Keywords
- mRNA Vaccine
- Durvalumab
- MEDI4736
- anti-PD-L1
- tremelimumab
- anti-CTLA-4
- BI 1361849
Last Updated
February 23, 2021