A Study of LY3435151 in Participants With Solid Tumors

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.

primary · POSTED

A DLT is defined as an Adverse Event that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0: 1. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT 8. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.

Zero participants were analyzed. This outcome was not determined because the study terminated before completion of Part A of the dose escalation period.

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secondary · POSTED

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151.

All randomized participants who received at least one dose of study drug and had evaluable PK data.

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secondary · POSTED

PK: Cmax of LY3435151 in Combination with Pembrolizumab.

Zero participants were analyzed. The study was terminated early and no data was collected.

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secondary · POSTED

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100.

Zero participants were analyzed. The study was terminated early and no data was collected.

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secondary · POSTED

Disease Control Rate (DCR) is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Zero participants were analyzed. The study was terminated early and no data was collected.

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secondary · POSTED

DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Zero participants were analyzed. The study was terminated early and no data was collected.

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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-cervical-cancer-keytruda-qlex-d7d2e489
nct id: NCT04099277
trial label: A Study of LY3435151 in Participants With Solid Tumors
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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0000
source section id
NCT04099277-om-0000
source outcome index
0
endpoint
Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs)
endpoint definition
A DLT is defined as an Adverse Event that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0: 1. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT 8. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
time origin
Baseline through Cycle 2 (21 Day Cycles)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed. This outcome was not determined because the study terminated before completion of Part A of the dose escalation period.
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-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0001
source section id
NCT04099277-om-0001
source outcome index
1
endpoint
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151
endpoint definition
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151.
time origin
Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants who received at least one dose of study drug and had evaluable PK data.
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-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0002
source section id
NCT04099277-om-0002
source outcome index
2
endpoint
PK: Cmax of LY3435151 in Combination With Pembrolizumab
endpoint definition
PK: Cmax of LY3435151 in Combination with Pembrolizumab.
time origin
Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed. The study was terminated early and no data was collected.
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-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0003
source section id
NCT04099277-om-0003
source outcome index
3
endpoint
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
endpoint definition
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100.
time origin
Baseline through Disease Progression or Death (Up to 4 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed. The study was terminated early and no data was collected.
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-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0004
source section id
NCT04099277-om-0004
source outcome index
4
endpoint
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease
endpoint definition
Disease Control Rate (DCR) is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
time origin
Baseline through Measured Progressive Disease (Up to 4 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed. The study was terminated early and no data was collected.
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-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0005
source section id
NCT04099277-om-0005
source outcome index
5
endpoint
Duration of Response (DoR)
endpoint definition
DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
time origin
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed. The study was terminated early and no data was collected.
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-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0000
arm key
OG000
arm label
10 mg LY3435151
regimen
Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04099277-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0001
arm key
OG000
arm label
10 mg LY3435151
regimen
Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04099277-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0002
arm key
OG000
arm label
10 mg LY3435151
regimen
Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04099277-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0003
arm key
OG000
arm label
10 mg LY3435151
regimen
Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04099277-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0004
arm key
OG000
arm label
10 mg LY3435151
regimen
Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04099277-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
outcome key
om-0005
arm key
OG000
arm label
10 mg LY3435151
regimen
Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04099277-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT04099277
harm key
EG000
source section id
NCT04099277-ae
event group key
EG000
event group label
10 mg LY3435151
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Up to 4 Months
event definition
All randomized participants.
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