TriangleNCT04472429 · OUTCOME
Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
What was measured
tmax was defined as the time to the maximum serum concentration of retifanlimab.
Analysis population: PK Evaluable Population
Groups in this outcome
Retifanlimab 500 mg Q4W + Chemotherapy
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
| Group | Source count |
|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 150 |
| Placebo + Chemotherapy | 0 |
| Retifanlimab 500 mg Q4W | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 0.720 | 35.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 35.8
- value
- 0.720
- denoms
- counts
- group Id
- OG000
- value
- 150
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- tmax was defined as the time to the maximum serum concentration of retifanlimab.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
- id
- OG000
- title
- Retifanlimab 500 mg Q4W + Chemotherapy
- description
- Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
- id
- OG001
- title
- Placebo + Chemotherapy
- description
- In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
- id
- OG002
- title
- Retifanlimab 500 mg Q4W
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Evaluable Population
- reporting Status
- POSTED
- time Frame
- preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
- title
- Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice