A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

Draft scope assessment: unclear. Attached because the study's own record names KRAS and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The following toxicities graded for severity using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), were considered a DLT if judged by the investigator to be possibly related to study investigational products: 1) Grade 4 nonhematologic toxicity (ie. not a laboratory finding). 2) Grade 4 hematologic toxicity lasting ≥ 7 days, except thrombocytopenia: 3) Grade 4 thrombocytopenia of any duration 4) Grade 3 thrombocytopenia associated with clinically significant bleeding 5) Any nonhematologic AE ≥ Grade 3 in severity, with some exceptions 6) Any Grade 3 or Grade 4 nonhematologic laboratory value that meets one of the study criteria 7) Febrile neutropenia Grade 3 or Grade 4 8) Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity. 9) Any treatment-related toxicity that causes participant to discontinue treatment during Cycle 1. 10) Grade 5 toxicity 11) Any other clinically significant toxicity judged to be a DLT by investigator.

The DLT evaluable population included all participants who received at least 1 dose of study treatment and were either observed for safety for 21 days after the first dose of treatment or experienced a DLT prior to 21 days after the first dose of treatment.

→

primary · POSTED

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

All participants who received at least 1 dose of study treatment. For AEs which occurred during Part 1 prior to switch-over, the information is in the Part 1: V941 Monotherapy column. For AEs which occurred during Part 1 subsequent to switch-over, the information is in the Part 1: V941 + Pembrolizumab column.

→

primary · POSTED

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinued study treatment due to an AE is reported.

→

secondary · POSTED

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by investigator is reported.

All participants who received at least 1 dose of study treatment. Per protocol, the 1 participant who switched over from Arm 1 Part 1: V941 Monotherapy to Arm 2 Part 1: V941 + Pembrolizumab was excluded from Arm 2 Part 1: V941 + Pembrolizumab for this outcome measure.

→

secondary · POSTED

The presence of mutant KRAS specific T cells (G12D, G12V, G13D, G12C, and Wild type) in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The post-treatment ELISpot readout for a cycle is reported. A cycle is 3 weeks.

Participants with centrally-confirmed tumor KRAS mutations, with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study treatment. The number of participants analyzed indicates a pre-treatment ELISpot readout for a cycle and a post-treatment ELISpot readout for a cycle, which are required for a participant's data to be reported for a particular cycle. A cycle is 3 weeks.

→

secondary · POSTED

Mean change from baseline in the quantity of mutant KRAS specific T cells in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The mean change is reported.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id: NCT03948763
trial label: A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
applicability: unclear
applicability note: Attached because the study's own record names KRAS and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0000
source section id
NCT03948763-om-0000
source outcome index
0
endpoint
Dose-Limiting Toxicities (DLTs)
endpoint definition
The following toxicities graded for severity using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), were considered a DLT if judged by the investigator to be possibly related to study investigational products: 1) Grade 4 nonhematologic toxicity (ie. not a laboratory finding). 2) Grade 4 hematologic toxicity lasting ≥ 7 days, except thrombocytopenia: 3) Grade 4 thrombocytopenia of any duration 4) Grade 3 thrombocytopenia associated with clinically significant bleeding 5) Any nonhematologic AE ≥ Grade 3 in severity, with some exceptions 6) Any Grade 3 or Grade 4 nonhematologic laboratory value that meets one of the study criteria 7) Febrile neutropenia Grade 3 or Grade 4 8) Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity. 9) Any treatment-related toxicity that causes participant to discontinue treatment during Cycle 1. 10) Grade 5 toxicity 11) Any other clinically significant toxicity judged to be a DLT by investigator.
time origin
Cycle 1 (Up to 21 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The DLT evaluable population included all participants who received at least 1 dose of study treatment and were either observed for safety for 21 days after the first dose of treatment or experienced a DLT prior to 21 days after the first dose of treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0001
source section id
NCT03948763-om-0001
source outcome index
1
endpoint
Number of Participants Who Experienced an Adverse Event (AE)
endpoint definition
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
time origin
Up to approximately 27 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose of study treatment. For AEs which occurred during Part 1 prior to switch-over, the information is in the Part 1: V941 Monotherapy column. For AEs which occurred during Part 1 subsequent to switch-over, the information is in the Part 1: V941 + Pembrolizumab column.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0002
source section id
NCT03948763-om-0002
source outcome index
2
endpoint
Number of Participants Who Discontinued Study Treatment Due to an AE
endpoint definition
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinued study treatment due to an AE is reported.
time origin
Up to approximately 24 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose of study treatment. For AEs which occurred during Part 1 prior to switch-over, the information is in the Part 1: V941 Monotherapy column. For AEs which occurred during Part 1 subsequent to switch-over, the information is in the Part 1: V941 + Pembrolizumab column.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0003
source section id
NCT03948763-om-0003
source outcome index
3
endpoint
Objective Response Rate (ORR)
endpoint definition
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by investigator is reported.
time origin
Up to approximately 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose of study treatment. Per protocol, the 1 participant who switched over from Arm 1 Part 1: V941 Monotherapy to Arm 2 Part 1: V941 + Pembrolizumab was excluded from Arm 2 Part 1: V941 + Pembrolizumab for this outcome measure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0004
source section id
NCT03948763-om-0004
source outcome index
4
endpoint
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
endpoint definition
The presence of mutant KRAS specific T cells (G12D, G12V, G13D, G12C, and Wild type) in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The post-treatment ELISpot readout for a cycle is reported. A cycle is 3 weeks.
time origin
Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with centrally-confirmed tumor KRAS mutations, with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study treatment. The number of participants analyzed indicates a pre-treatment ELISpot readout for a cycle and a post-treatment ELISpot readout for a cycle, which are required for a participant's data to be reported for a particular cycle. A cycle is 3 weeks.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0005
source section id
NCT03948763-om-0005
source outcome index
5
endpoint
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
endpoint definition
Mean change from baseline in the quantity of mutant KRAS specific T cells in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The mean change is reported.
time origin
Baseline and Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with centrally-confirmed tumor KRAS mutations, with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study treatment. The number of participants analyzed indicates a pre-treatment ELISpot readout for a cycle and a post-treatment ELISpot readout for a cycle, which are required for a participant's data to be reported for a particular cycle. A cycle is 3 weeks.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0000
arm key
OG000
arm label
Part 1: V941 Monotherapy
regimen
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0000
arm key
OG001
arm label
Part 1: V941 + Pembrolizumab
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0000
arm key
OG002
arm label
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0000
arm key
OG003
arm label
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0000
arm key
OG004
arm label
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0001
arm key
OG000
arm label
Part 1: V941 Monotherapy
regimen
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0001
arm key
OG001
arm label
Part 1: V941 + Pembrolizumab
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0001
arm key
OG002
arm label
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0001
arm key
OG003
arm label
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0001
arm key
OG004
arm label
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0002
arm key
OG000
arm label
Part 1: V941 Monotherapy
regimen
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
outcome key
om-0002
arm key
OG001
arm label
Part 1: V941 + Pembrolizumab
regimen
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03948763-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
harm key
EG000
source section id
NCT03948763-ae
event group key
EG000
event group label
Part 1: V941 Monotherapy
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 27 months
event definition
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
harm key
EG001
source section id
NCT03948763-ae
event group key
EG001
event group label
Part 1: V941 + Pembrolizumab
serious affected
6
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Up to approximately 27 months
event definition
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
harm key
EG002
source section id
NCT03948763-ae
event group key
EG002
event group label
Part 1: V941 + Pembrolizumab (Switched Over From V941 Monotherapy)
serious affected
0
serious at risk
1
other affected
0
other at risk
1
frequency threshold
5
collection period
Up to approximately 27 months
event definition
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
harm key
EG003
source section id
NCT03948763-ae
event group key
EG003
event group label
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
serious affected
5
serious at risk
20
other affected
20
other at risk
20
frequency threshold
5
collection period
Up to approximately 27 months
event definition
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
harm key
EG004
source section id
NCT03948763-ae
event group key
EG004
event group label
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
serious affected
7
serious at risk
16
other affected
16
other at risk
16
frequency threshold
5
collection period
Up to approximately 27 months
event definition
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT03948763
harm key
EG005
source section id
NCT03948763-ae
event group key
EG005
event group label
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
serious affected
9
serious at risk
16
other affected
15
other at risk
16
frequency threshold
5
collection period
Up to approximately 27 months
event definition
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice