NCT03797326 · STUDY IN CONTEXT

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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.

secondary · POSTED

DCR was defined per RECIST 1.1 as the percentage of participants who have a 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) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

All allocated participants who received at least 1 dose of study intervention.

→

secondary · POSTED

DCR was defined per RECIST 1.1 as the percentage of participants who have a 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) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD.\]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented.

All allocated participants who received at least 1 dose of study intervention. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

→

secondary · POSTED

For participants who demonstrate a confirmed 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 RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response.

→

secondary · POSTED

For participants who demonstrate a confirmed 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 RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.

All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

→

secondary · POSTED

PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

All allocated participants who received at least 1 dose of study intervention.

→

secondary · POSTED

PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

All allocated participants who received at least 1 dose of study intervention.

→

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-pancreatic-cancer-locally-advanced-06747430
nct id: NCT03797326
trial label: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced 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: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0000
source section id
NCT03797326-om-0000
source outcome index
0
endpoint
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment
endpoint definition
DCR was defined per RECIST 1.1 as the percentage of participants who have a 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) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
time origin
Up to approximately 66 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study intervention.
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0001
source section id
NCT03797326-om-0001
source outcome index
1
endpoint
Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
endpoint definition
DCR was defined per RECIST 1.1 as the percentage of participants who have a 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) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD.\]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented.
time origin
Up to approximately 66 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study intervention. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0002
source section id
NCT03797326-om-0002
source outcome index
2
endpoint
Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment
endpoint definition
For participants who demonstrate a confirmed 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 RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
time origin
Up to approximately 66 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response.
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0003
source section id
NCT03797326-om-0003
source outcome index
3
endpoint
Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
endpoint definition
For participants who demonstrate a confirmed 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 RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.
time origin
Up to approximately 66 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0004
source section id
NCT03797326-om-0004
source outcome index
4
endpoint
Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment
endpoint definition
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
time origin
Up to approximately 66 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study intervention.
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0005
source section id
NCT03797326-om-0005
source outcome index
5
endpoint
Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
endpoint definition
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
time origin
Up to approximately 66 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study intervention.
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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0000
arm key
OG000
arm label
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
regimen
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0000
arm key
OG001
arm label
Cohort B: Ovarian Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0001
arm key
OG000
arm label
Cohort C: Gastric Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
99
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0001
arm key
OG001
arm label
Cohort D1: Colorectal Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
105
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0001
arm key
OG002
arm label
Cohort D2: Colorectal Cancer (Lenva)
regimen
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0001
arm key
OG003
arm label
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
101
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0001
arm key
OG004
arm label
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
102
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0001
arm key
OG005
arm label
Cohort G: Pancreatic Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0001#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0002
arm key
OG000
arm label
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
regimen
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0002
arm key
OG001
arm label
Cohort B: Ovarian Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0003
arm key
OG000
arm label
Cohort C: Gastric Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
outcome key
om-0003
arm key
OG001
arm label
Cohort D1: Colorectal Cancer (Lenva + Pembro)
regimen
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03797326-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG000
source section id
NCT03797326-ae
event group key
EG000
event group label
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
serious affected
16
serious at risk
31
other affected
30
other at risk
31
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG001
source section id
NCT03797326-ae
event group key
EG001
event group label
Cohort B: Ovarian Cancer (Lenva + Pembro)
serious affected
19
serious at risk
31
other affected
31
other at risk
31
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG002
source section id
NCT03797326-ae
event group key
EG002
event group label
Cohort C: Gastric Cancer (Lenva + Pembro)
serious affected
57
serious at risk
99
other affected
95
other at risk
99
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG003
source section id
NCT03797326-ae
event group key
EG003
event group label
Cohort D1: Colorectal Cancer (Lenva + Pembro)
serious affected
55
serious at risk
105
other affected
103
other at risk
105
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG004
source section id
NCT03797326-ae
event group key
EG004
event group label
Cohort D2: Colorectal Cancer (Lenva)
serious affected
12
serious at risk
30
other affected
29
other at risk
30
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG005
source section id
NCT03797326-ae
event group key
EG005
event group label
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
serious affected
30
serious at risk
101
other affected
98
other at risk
101
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG006
source section id
NCT03797326-ae
event group key
EG006
event group label
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
serious affected
62
serious at risk
102
other affected
100
other at risk
102
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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-pancreatic-cancer-locally-advanced-06747430
nct id
NCT03797326
harm key
EG007
source section id
NCT03797326-ae
event group key
EG007
event group label
Cohort G: Pancreatic Cancer (Lenva + Pembro)
serious affected
49
serious at risk
103
other affected
101
other at risk
103
frequency threshold
5
collection period
Up to approximately 66 months
event definition
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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

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Preserved source evidence · Not medical advice