NCT03075527 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of paticipants
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death. The median treatment duration is 1.91 months with range (0.00 months - 23.46 months).
What was measured
Overall Response Rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment based on RECIST v1.1 criteria.
Analysis population: The analysis population is comprised of eligible and treated patients.
Groups in this outcome
Tremelimumab + Durvalumab
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression. Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
| Group | Source count |
|---|---|
| Tremelimumab + Durvalumab | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tremelimumab + Durvalumab | 0.105 | Not reported | 0.045 | 0.229 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.045
- upper Limit
- 0.229
- value
- 0.105
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- Overall Response Rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment based on RECIST v1.1 criteria.
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression. Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
- id
- OG000
- title
- Tremelimumab + Durvalumab
- param Type
- NUMBER
- population Description
- The analysis population is comprised of eligible and treated patients.
- reporting Status
- POSTED
- time Frame
- ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death. The median treatment duration is 1.91 months with range (0.00 months - 23.46 months).
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- proportion of paticipants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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