TriangleNCT05255601 · OUTCOME
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 1 cycle, defined as 28 days
What was measured
Hepatic DLT * ALT or AST \> 8 × ULN * ALT or AST \> 5 and ≤ 8 × ULN, that fails to return to ≤ Grade 1 within 2 weeks despite medical intervention. * TB \> 5 × ULN. * ALT or AST \> 3 × ULN and concurrent total bilirubin \> 2 × ULN. Non-Hematologic DLT * ≥ Grade 2 episcleritis, uveitis, iritis or any other immune-related eye pain or reduction in visual acuity that requires systemic treatment. * ≥ Grade 3 non-hepatic or non-hematologic toxicity with the exceptions noted below. Hematologic DLT * Grade 4 anemia not explained by underlying disease. * Grade 3 febrile neutropenia lasting \> 48 hours, or Grade 4 febrile neutropenia * Grade 4 neutropenia that does not resolve to Grade 3 or less within 5 days of initiation of granulocyte colony stimulating factor. * Grade 3 thrombocytopenia associated with clinically significant bleeding. * Grade 3 hemolysis
Analysis population: All treated participants in part A
Groups in this outcome
Part A - Flat Dosing (AF)
Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W
Part A - Age/Weight-based Dosing (AW)
Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W
| Group | Source count |
|---|---|
| Part A - Flat Dosing (AF) | 4 |
| Part A - Age/Weight-based Dosing (AW) | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - Flat Dosing (AF) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - Age/Weight-based Dosing (AW) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Hepatic DLT * ALT or AST \> 8 × ULN * ALT or AST \> 5 and ≤ 8 × ULN, that fails to return to ≤ Grade 1 within 2 weeks despite medical intervention. * TB \> 5 × ULN. * ALT or AST \> 3 × ULN and concurrent total bilirubin \> 2 × ULN. Non-Hematologic DLT * ≥ Grade 2 episcleritis, uveitis, iritis or any other immune-related eye pain or reduction in visual acuity that requires systemic treatment. * ≥ Grade 3 non-hepatic or non-hematologic toxicity with the exceptions noted below. Hematologic DLT * Grade 4 anemia not explained by underlying disease. * Grade 3 febrile neutropenia lasting \> 48 hours, or Grade 4 febrile neutropenia * Grade 4 neutropenia that does not resolve to Grade 3 or less within 5 days of initiation of granulocyte colony stimulating factor. * Grade 3 thrombocytopenia associated with clinically significant bleeding. * Grade 3 hemolysis
- groups
- description
- Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W
- id
- OG000
- title
- Part A - Flat Dosing (AF)
- description
- Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W
- id
- OG001
- title
- Part A - Age/Weight-based Dosing (AW)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants in part A
- reporting Status
- POSTED
- time Frame
- 1 cycle, defined as 28 days
- title
- Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice