NCT03907488 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
- id
- FG000
- title
- Arm I (Chemotherapy, Nivolumab, Radiation)
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Brentuximab Vedotin: Given IV Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
- id
- FG001
- title
- Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 20
- group Id
- FG001
- num Subjects
- 20
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 13
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 9
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 8
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 8
- type
- not protocol specified
- reasons
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 15
- type
- Ineligible
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 496
- group Id
- FG001
- num Subjects
- 498
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 450
- group Id
- FG001
- num Subjects
- 425
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 46
- group Id
- FG001
- num Subjects
- 73
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
- id
- FG000
- title
- Arm I (Chemotherapy, Nivolumab, Radiation)
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Brentuximab Vedotin: Given IV Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
- id
- FG001
- title
- Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 20
- group Id
- FG001
- num Subjects
- 20
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 13
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 9
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 8
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 8
- type
- not protocol specified
- reasons
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 15
- type
- Ineligible
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 496
- group Id
- FG001
- num Subjects
- 498
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 450
- group Id
- FG001
- num Subjects
- 425
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 46
- group Id
- FG001
- num Subjects
- 73
- type
- NOT COMPLETED
- title
- Overall Study
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