Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Research Institute, New York City | OTHER |
| Boehringer Ingelheim | INDUSTRY |
| MedImmune LLC | INDUSTRY |
| CureVac |
Not provided
Not provided
Not provided
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: messenger ribonucleic acid (mRNA) Vaccine [BI 1361849 (formerly CV9202)] + anti-programmed death ligand 1 (PD-L1) antibody [durvalumab]
Arm B: messenger ribonucleic acid (mRNA) Vaccine [BI 1361849] + anti-programmed death ligand 1 (PD-L1) [durvalumab] + anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody [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).
This was a Phase 1/2, 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 in subjects with NSCLC.
Up to 56 subjects were planned for enrollment from up to 8 clinical sites in 2 arms:
Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 antibody [durvalumab]
Arm B: mRNA Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 antibody [tremelimumab]
Subjects must have had histologically confirmed 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 and must not have had progression at or before 12 weeks after start of the prior anti-PD-1/PD-L1 treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BI 1361849 mRNA Vaccine + durvalumab | Experimental | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. |
|
| Arm B: BI 1361849 mRNA Vaccine + durvalumab + tremelimumab | Experimental | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | anti-PD-L1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) | Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 20.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. AEs were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are AEs that occurred or worsened in severity after administration of the first dose of study treatment. For each arm, the first 6 subjects were evaluated for dose limiting toxicities (DLTs). Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment. | up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median PFS by RECIST 1.1 as Estimated Using the Kaplan-Meier Method | Progression Free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or to the date of death, if disease progression did not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions. |
Not provided
Inclusion Criteria
Exclusion Criteria
Subjects may not enter the study if they fulfill any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jhanelle Gray, MD | H. Lee Moffitt Cancer Center and Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Gilbert | Arizona | 85234 | United States | ||
| Research Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19097774 | Background | Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. | |
| Background | Bohnsack O, Hoos A, Ludajic K. Adaptation of the immune related response criteria: irRECIST. Ann Oncol. 2014 Sep;25(suppl 4):iv361-iv72 [Abstract 4958]. doi: 10.1093/annonc/mdu342.23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
61 subjects were enrolled; 24 into Arm A and 37 into Arm B. Of these 61 subjects, 57 were treated with at least one dose of study treatment; 23 in Arm A and 34 in Arm B.
No dose adjustments were made and as a result all patients treated in each arm are presented.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: BI 1361849 mRNA Vaccine + Durvalumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 30, 2021 | Jun 17, 2022 |
Not provided
Not provided
| INDUSTRY |
| PharmaJet, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
| Tremelimumab | Drug | anti-CTLA-4 |
|
| BI 1361849 | Biological | mRNA Vaccine |
|
|
| PharmaJet Tropis® device | Device | The PharmaJet Tropis® device was used for the intradermal administration of the BI 1361849 vaccine components. |
|
| up to 15 months |
| Number of Subjects Without Progression at 8 and 24 Weeks by RECIST 1.1 | Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression did not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions. | up to 24 weeks |
| Median PFS by irRECIST as Estimated Using the Kaplan-Meier Method | Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression according to immune related Response Evaluation Criteria in Solid Tumors (irRECIST) or to the date of death, if disease progression did not occur. Per irRECIST, progressive disease (irPD) is defined as a ≥ 20% increase from nadir in the total measurable tumor burden (TMTB). | up to 15 months |
| Number of Subjects Without Progression at 8 and 24 Weeks by irRECIST | Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression did not occur. Per irRECIST, progressive disease (irPD) is defined as a ≥ 20% increase from nadir in the total measurable tumor burden (TMTB). | up to 24 weeks |
| Number of Subjects With Best Overall Tumor Response By RECIST 1.1 | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions; stable disease (SD): small changes that do not meet above criteria. | up to 15 months |
| Number of Subjects With Objective Responses at 8 and 24 Weeks By RECIST 1.1 | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; stable disease (SD): small changes that do not meet above criteria. An Objective Response is defined as a CR or PR over a period of at least 4 weeks. | up to 24 weeks |
| Duration of Response (DoR) By RECIST 1.1 | Duration of Response (DoR) was defined as the interval between the date of earliest determination of CR or PR to the date of earliest determination of progressive disease (PD), clinical progression or death, whatever occurred first. | up to 15 months |
| Number of Subjects With Best Overall Tumor Response By irRECIST | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per irRECIST, responses are categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in TMTB; Stable Disease (irSD): not meeting above criteria. | up to 15 months |
| Number of Subjects With Objective Responses at 8 and 24 Weeks By irRECIST | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per irRECIST, responses are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria. An Objective Response is defined as an irCR or irPR over a period of at least 4 weeks. | up to 24 weeks |
| Duration of Response (DoR) by irRECIST | Duration of Response (DoR) was defined as the interval between the date of earliest determination of irCR or irPR to the date of earliest determination of progressive disease (irPD), clinical progression or death, whatever occurred first. | Up tp 15 months |
| Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | After completion of treatment, all subjects were followed for survival every 6 months following initiation of study treatment until October 29, 2021 when all post-study follow-up was completed. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive. | up to October 29, 2021 |
| Tampa |
| Florida |
| 33612 |
| United States |
| Research Facility | Detroit | Michigan | 48201 | United States |
| Research Facility | New York | New York | 10016 | United States |
| Research Facility | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine |
|
| COMPLETED | Completed is defined as completed all 12 cycles of study treatment. |
|
| NOT COMPLETED |
|
|
All subjects who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: BI 1361849 mRNA Vaccine + Durvalumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine |
| BG001 | Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline | PS 0 = Fully active, able to carry on all pre-disease performance without restriction; PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; PS 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; PS 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; PS 5 = Dead | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) | Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 20.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. AEs were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are AEs that occurred or worsened in severity after administration of the first dose of study treatment. For each arm, the first 6 subjects were evaluated for dose limiting toxicities (DLTs). Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment. | All subjects who received at least one dose of study medication. | Posted | Count of Participants | Participants | up to 15 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Median PFS by RECIST 1.1 as Estimated Using the Kaplan-Meier Method | Progression Free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or to the date of death, if disease progression did not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions. | All subjects who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | up to 15 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Without Progression at 8 and 24 Weeks by RECIST 1.1 | Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression did not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions. | All subjects who received at least one dose of study medication. | Posted | Count of Participants | Participants | up to 24 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Median PFS by irRECIST as Estimated Using the Kaplan-Meier Method | Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression according to immune related Response Evaluation Criteria in Solid Tumors (irRECIST) or to the date of death, if disease progression did not occur. Per irRECIST, progressive disease (irPD) is defined as a ≥ 20% increase from nadir in the total measurable tumor burden (TMTB). | All subjects who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | up to 15 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Without Progression at 8 and 24 Weeks by irRECIST | Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression did not occur. Per irRECIST, progressive disease (irPD) is defined as a ≥ 20% increase from nadir in the total measurable tumor burden (TMTB). | All subjects who received at least one dose of study medication. | Posted | Count of Participants | Participants | up to 24 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Best Overall Tumor Response By RECIST 1.1 | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions; stable disease (SD): small changes that do not meet above criteria. | All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment. | Posted | Count of Participants | Participants | up to 15 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Objective Responses at 8 and 24 Weeks By RECIST 1.1 | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; stable disease (SD): small changes that do not meet above criteria. An Objective Response is defined as a CR or PR over a period of at least 4 weeks. | All subjects who received at least one dose of study medication. | Posted | Count of Participants | Participants | up to 24 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) By RECIST 1.1 | Duration of Response (DoR) was defined as the interval between the date of earliest determination of CR or PR to the date of earliest determination of progressive disease (PD), clinical progression or death, whatever occurred first. | All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment and had a response of CR or PR. | Posted | Median | 95% Confidence Interval | weeks | up to 15 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Best Overall Tumor Response By irRECIST | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per irRECIST, responses are categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in TMTB; Stable Disease (irSD): not meeting above criteria. | All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment. | Posted | Count of Participants | Participants | up to 15 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Objective Responses at 8 and 24 Weeks By irRECIST | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per irRECIST, responses are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria. An Objective Response is defined as an irCR or irPR over a period of at least 4 weeks. | All subjects who received at least one dose of study medication. | Posted | Count of Participants | Participants | up to 24 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) by irRECIST | Duration of Response (DoR) was defined as the interval between the date of earliest determination of irCR or irPR to the date of earliest determination of progressive disease (irPD), clinical progression or death, whatever occurred first. | All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment and had a response of irCR or irPR. | Posted | Median | 95% Confidence Interval | weeks | Up tp 15 months |
| ||||||||||||||||||||||||||||||
| Secondary | Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | After completion of treatment, all subjects were followed for survival every 6 months following initiation of study treatment until October 29, 2021 when all post-study follow-up was completed. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive. | All subjects who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | up to October 29, 2021 |
|
up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021.
AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: BI 1361849 mRNA Vaccine + Durvalumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine | 12 | 23 | 14 | 23 | 23 | 23 |
| EG001 | Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine | 22 | 34 | 22 | 34 | 33 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Spine fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Stent placement | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
The study was not randomized. There was disparity between the arms regarding the number of subjects treated before and after the protocol amendment which enabled inclusion of subjects who had 1 prior line of anti-PD-1/PD-L1 therapy. Seven subjects were treated in Arm A and 1 subject in Arm B before implementation of the amendment. The results for Arms A and B are not intended for comparison. All post study follow-up for the collection of survival was discontinued as of 29 October 2021.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Skipper PhD | Ludwig Institute for Cancer Research | 12124501539 | jskipper@lcr.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2020 | Jun 17, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| PS 1 |
|
| PS 2 |
|
| Treatment-related Adverse Event (TRAE) |
|
|
| Treatment-emergent Serious Adverse Event (SAE) |
|
|
| Treatment-related SAE |
|
|
| TEAE leading to treatment discontinuation |
|
|
| Deaths Within the AE Reporting Period |
|
|
| DLTs |
|
|
The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components.
Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles.
Durvalumab: anti-PD-L1
Tremelimumab: anti-CTLA-4
BI 1361849: mRNA Vaccine
|
|
|
|
The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components.
Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles.
Durvalumab: anti-PD-L1
Tremelimumab: anti-CTLA-4
BI 1361849: mRNA Vaccine
|
|
|
|
| OG001 | Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine |
|
|
| OG001 | Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine |
|
|
|
|
| OG001 | Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab | The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine |
|
|
| OG001 |
| Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab |
The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine |
|
|
|
|
|
|