TriangleNCT03782064 · OUTCOME
Number of Patients Who Develop Immunologic Response to Nivolumab and the DC/MM Fusion Vaccine
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
- 2 years
What was measured
We planned to evaluate the immunologic response to treatment in blood and bone marrow. Two patients were treated on protocol and both came off due to disease progression early in the course of therapy (one patient during cycle 1 and one patient during cycle 3.) As such, there is insufficient data to perform what had been planned in correlative science studies so no samples were analyzed. This study has been stopped and no further patients are being enrolled and no further samples are being collected. No data has been obtained for any immune analysis; therefore no immune or clinical data will be reported on this trial.
Analysis population: Two patients were treated on protocol and both came off due to disease progression early in the course of therapy. Both participants did not achieve a defined clinical response. There is insufficient data to perform what had been planned in correlative science studies or in immune analysis. This study has been stopped and no further patients are being enrolled and no further samples are being collected.
Groups in this outcome
Nivolumab+DC/Myeloma Fusions/GM-CSF
* Nivolumab will be given every two weeks * The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells. DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
| Group | Source count |
|---|---|
| Nivolumab+DC/Myeloma Fusions/GM-CSF | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab+DC/Myeloma Fusions/GM-CSF | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- We planned to evaluate the immunologic response to treatment in blood and bone marrow. Two patients were treated on protocol and both came off due to disease progression early in the course of therapy (one patient during cycle 1 and one patient during cycle 3.) As such, there is insufficient data to perform what had been planned in correlative science studies so no samples were analyzed. This study has been stopped and no further patients are being enrolled and no further samples are being collected. No data has been obtained for any immune analysis; therefore no immune or clinical data will be reported on this trial.
- groups
- description
- * Nivolumab will be given every two weeks * The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells. DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
- id
- OG000
- title
- Nivolumab+DC/Myeloma Fusions/GM-CSF
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Two patients were treated on protocol and both came off due to disease progression early in the course of therapy. Both participants did not achieve a defined clinical response. There is insufficient data to perform what had been planned in correlative science studies or in immune analysis. This study has been stopped and no further patients are being enrolled and no further samples are being collected.
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Number of Patients Who Develop Immunologic Response to Nivolumab and the DC/MM Fusion Vaccine
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice