TriangleNCT02888743 · OUTCOME
Objective Response Per Immune-related Response (irRC) Criteria
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
- Up to 2 years
What was measured
NSCLC only: Proportions with irCR, irPR, irSD, irPD, and NA are presented with 90% exact binomial confidence intervals. The Immune-Related Response Criteria (irRC) is a set of published rules that defines when cancer tumors improve, stay the same, or worsen during treatment with an immuno-oncology drug. The response criteria are: irCR: Complete disappearance of all lesions, no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented; irPR: decrease in tumor burden \>50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later; irPD: increase in tumor burden \>25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later; irSD: not meeting criteria for irCR or irPR in the absence of irPD.
Analysis population: Patients receiving at least one regimen of protocol therapy.
Groups in this outcome
Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
Arm C (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
| Group | Source count |
|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 26 |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 26 |
| Arm C (Tremelimumab, Durvalumab) | 26 |
Reported measurements
Source class 1
irCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Tremelimumab, Durvalumab) | 0 | Not reported | Not reported | Not reported | Not reported |
irPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Tremelimumab, Durvalumab) | 2 | Not reported | Not reported | Not reported | Not reported |
irSD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 9 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 11 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Tremelimumab, Durvalumab) | 9 | Not reported | Not reported | Not reported | Not reported |
irPD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 9 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 8 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Tremelimumab, Durvalumab) | 11 | Not reported | Not reported | Not reported | Not reported |
Missing/not available
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Tremelimumab, Durvalumab) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- irCR
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- irPR
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 9
- title
- irSD
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 11
- title
- irPD
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- title
- Missing/not available
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 26
- units
- Participants
- description
- NSCLC only: Proportions with irCR, irPR, irSD, irPD, and NA are presented with 90% exact binomial confidence intervals. The Immune-Related Response Criteria (irRC) is a set of published rules that defines when cancer tumors improve, stay the same, or worsen during treatment with an immuno-oncology drug. The response criteria are: irCR: Complete disappearance of all lesions, no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented; irPR: decrease in tumor burden \>50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later; irPD: increase in tumor burden \>25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later; irSD: not meeting criteria for irCR or irPR in the absence of irPD.
- groups
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG000
- title
- Arm A (Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG001
- title
- Arm B (Tremelimumab, Durvalumab, LD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
- id
- OG002
- title
- Arm C (Tremelimumab, Durvalumab)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Patients receiving at least one regimen of protocol therapy.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Objective Response Per Immune-related Response (irRC) Criteria
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice