TriangleNCT04472429 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 445 days
What was measured
ORR was defined as the percentage of participants with a confirmed CR or PR at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Analysis population: Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
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.
| Group | Source count |
|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 154 |
| Placebo + Chemotherapy | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 55.8 | Not reported | 47.6 | 63.8 | Not reported |
| Placebo + Chemotherapy | 44.2 | Not reported | 36.2 | 52.4 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0129
- statistical Comment
- The nominal one-sided p-value was calculated from a stratified Cochran-Mantel-Haenszel test.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0129
- statistical Comment
- The nominal one-sided p-value was calculated from a stratified Cochran-Mantel-Haenszel test.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 47.6
- upper Limit
- 63.8
- value
- 55.8
- group Id
- OG001
- lower Limit
- 36.2
- upper Limit
- 52.4
- value
- 44.2
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- ORR was defined as the percentage of participants with a confirmed CR or PR at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
- dispersion Type
- 95% Confidence Interval
- 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
- param Type
- NUMBER
- population Description
- Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
- reporting Status
- POSTED
- time Frame
- up to 445 days
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice