Trial · NCT03907488
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
NCT03907488, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-06-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma. Trials, record NCT03907488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03907488
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
- NCT number
- NCT03907488
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 994 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- 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
- First posted
- 2019-04-09
- Last updated
- 2026-10-22
- Results first posted
- 2025-06-12
- Limitations and caveats
Our trial has several limitations, including the short follow-up time. Secondary analyses and subgroup analyses that involved specified stratification factors were preplanned, but these analyses did not have adequate statistical power.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years | 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. |
| Secondary | Overall Survival | From date of registration to two years or death. | Will be reported as the count of participants who have died, measured at two years. Stratified log-rank test at two-sided alpha level of .05. |
| Secondary | Event-free Survival (EFS) | From date of registration to date of first occurrence of EFS event, assessed at 2 years | Will be reported as count of participants who have experienced an EFS event or death at two years. EFS Events are defined as: * Disease progression/relapse * Administration of non-protocol specified systemic anti-lymphoma therapy (i.e. salvage therapy) at any time after initiation of protocol therapy. * Administration of any non-protocol specified radiation therapy at any time afterinitiation of protocol therapy Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model. |
| Secondary | Number of Participants With of Adverse Events | Up to 2 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Secondary | Metabolic Complete Response Rate | 4-8 weeks after last dose of study drug | This outcome measure will be reported by 11/5/2025. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From date of registration to two years or death. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-free Survival (EFS) | From date of registration to date of first occurrence of EFS event, assessed at 2 years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With of Adverse Events | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Metabolic Complete Response Rate | 4-8 weeks after last dose of study drug |
Source ClinicalTrials.gov
Results by group698
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm I (Chemotherapy, Nivolumab, Radiation) | 41 | Participants | ||
| Progression Free Survival (PFS) | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 81 | Participants | ||
| Overall Survival | Arm I (Chemotherapy, Nivolumab, Radiation) | 7 | Participants | ||
| Overall Survival | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 14 | Participants | ||
| Event-free Survival (EFS) | Arm I (Chemotherapy, Nivolumab, Radiation) | 52 | Participants | ||
| Event-free Survival (EFS) | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 91 | Participants | ||
| Number of Participants With of Adverse Events | Arm I (Chemotherapy, Nivolumab, Radiation) | Abdominal distension | 1 | Participants | |
| Number of Participants With of Adverse Events | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Abdominal distension | 3 | Participants | |
| Number of Participants With of Adverse Events | Arm I (Chemotherapy, Nivolumab, Radiation) | Abdominal pain | 61 | Participants | |
| Number of Participants With of Adverse Events | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Abdominal pain | 110 | Participants |
1 to 10 of 698Source ClinicalTrials.gov
See all 698 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Chemotherapy, Nivolumab, Radiation) | 496 | |
| Overall Study | STARTED | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 498 | |
| Overall Study | COMPLETED | Arm I (Chemotherapy, Nivolumab, Radiation) | 450 | |
| Overall Study | COMPLETED | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 425 | |
| Overall Study | NOT COMPLETED | Arm I (Chemotherapy, Nivolumab, Radiation) | 46 | |
| Overall Study | NOT COMPLETED | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 73 |
Source ClinicalTrials.gov
Adverse events402
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Chemotherapy, Nivolumab, Radiation) | 251 | 481 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 252 | 476 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm I (Chemotherapy, Nivolumab, Radiation) | 23 | 481 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 28 | 476 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Chemotherapy, Nivolumab, Radiation) | 8 | 481 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 30 | 476 | |
| other | Sinus tachycardia | Cardiac disorders | Arm I (Chemotherapy, Nivolumab, Radiation) | 46 | 481 | |
| other | Sinus tachycardia | Cardiac disorders | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 71 | 476 | |
| other | Hypothyroidism | Endocrine disorders | Arm I (Chemotherapy, Nivolumab, Radiation) | 38 | 481 | |
| other | Hypothyroidism | Endocrine disorders | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 3 | 476 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Chemotherapy, Nivolumab, Radiation) | 7 | 487 |
| Total, all-cause mortality | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 14 | 483 |
| Total, other adverse events | Arm I (Chemotherapy, Nivolumab, Radiation) | 468 | 481 |
| Total, other adverse events | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 465 | 476 |
| Total, serious adverse events | Arm I (Chemotherapy, Nivolumab, Radiation) | 140 | 481 |
| Total, serious adverse events | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 18 | 476 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Chemotherapy, Nivolumab, Radiation) vs Arm II (Chemotherapy, Brentuximab Vedotin, Radiation): Overall Survival | Trial comparisons |
| Arm I (Chemotherapy, Nivolumab, Radiation) vs Arm II (Chemotherapy, Brentuximab Vedotin, Radiation): Event-free Survival (EFS) | Trial comparisons |
| Arm I (Chemotherapy, Nivolumab, Radiation) vs Arm II (Chemotherapy, Brentuximab Vedotin, Radiation): Progression Free Survival (PFS) | Trial comparisons |
| Arm I (Chemotherapy, Nivolumab, Radiation) vs Arm II (Chemotherapy, Brentuximab Vedotin, Radiation): deaths from any cause | Trial comparisons |
| Arm I (Chemotherapy, Nivolumab, Radiation) vs Arm II (Chemotherapy, Brentuximab Vedotin, Radiation): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03907488
GET https://conductscience.org/api/trials/v1/NCT03907488/results?page=2