Phase 1 / 2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With 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.
Locations & Contacts
Contact: Tara Louise Ackerman
Name Not Available
Trial Phase & Type
Ludwig Institute for Cancer Research
Secondary IDs NCI-2018-01133
Clinicaltrials.gov ID NCT03164772