Comparison · NCT03907488-cb77a710
Arm I (Chemotherapy, Nivolumab, Radiation) vs Arm II (Chemotherapy, Brentuximab Vedotin, Radiation): Progression Free Survival (PFS)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm I (Chemotherapy, Nivolumab, Radiation) vs Arm II (Chemotherapy, Brentuximab Vedotin, Radiation): Progression Free Survival (PFS). Trial comparisons, record NCT03907488-cb77a710. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03907488-cb77a710
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0842 | 0.0627 | 0.112 | wilson | |
| Risk in group 2 | 0.168 | 0.137 | 0.204 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0835 | -0.125 | -0.042 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.502 | 0.352 | 0.715 | log | |
| Odds ratio, group 1 over group 2 | 0.456 | 0.306 | 0.68 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm I (Chemotherapy, Nivolumab, Radiation) than on Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 12 | 7.98 | 23.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm I (Chemotherapy, Nivolumab, Radiation) | 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 | 41 | 487 | OG000 |
| Group 2 | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 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 | 81 | 483 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Progression Free Survival (PFS)
- Description
Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.
- Time frame
- From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years
- Population
- All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.
Source ClinicalTrials.gov
Trial
- Title
- Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
- NCT number
- NCT03907488
- Phases
- PHASE3
- Conditions
Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma, Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma, Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma, Ann Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma, Ann Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Lymphocyte-Rich Classic Hodgkin Lymphoma
- Interventions
Biospecimen Collection, Brentuximab Vedotin, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride, Filgrastim, Magnetic Resonance Imaging, Nivolumab, Pegfilgrastim, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy, Vinblastine Sulfate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03907488?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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