Trial · NCT03057795

Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma

NCT03057795, Phase 2, Active not recruiting, City of Hope Medical Center; results first posted 2023-03-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma. Trials, record NCT03057795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03057795

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
NCT number: NCT03057795
Status: Active not recruiting
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: City of Hope Medical Center
Conditions: Classic Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
Interventions: Brentuximab Vedotin, Laboratory Biomarker Analysis, Nivolumab
First posted: 2017-02-20
Last updated: 2026-10-26
Results first posted: 2023-03-23

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival at 18 Months	From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months.	Progression-free survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. When there is no censoring in progression-free survival prior to 18 months after the first dose of study treatment, the observed 18-month progression-free survival will be compared to the baseline of 65% by one-sided exact test of binomial proportion. In case of censoring in progression-free survival prior to 18 months after the first dose of study treatment, the Kaplan-Meier estimate for 18-month progression-free survival along with the Greenwood standard error estimator will be used for the testing of null hypothesis at 65%. Hodgkin Lymphoma(HL) response/progression was evaluated using 2014 Lugano Classification \[Cheson, Journal of Clinical Oncology 2014 Sep 20;32(27):3059-68\].
Secondary	Overall Survival at 18 Months	From the first dose of study treatment to death from any cause, assessed up to 18 months	Overall survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival at 18 Months	From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months.		percentage of survival probability	NUMBER
SECONDARY	Overall Survival at 18 Months	From the first dose of study treatment to death from any cause, assessed up to 18 months		percentage of survival probability	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival at 18 Months	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days		94	95% Confidence Interval 84 to 98	percentage of survival probability
Overall Survival at 18 Months	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days		98	95% Confidence Interval 88 to 100	percentage of survival probability

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	59
Overall Study	COMPLETED	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	59
Overall Study	NOT COMPLETED	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	0

Source ClinicalTrials.gov

Adverse events187

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	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	11	59	25
other	ASYMPTOMATIC CT SCAN CHANGES	Cardiac disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	1	59	6
other	PALPITATIONS	Cardiac disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	1	59	1
other	SINUS BRADYCARDIA	Cardiac disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	6	59	9
other	SINUS TACHYCARDIA	Cardiac disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	21	59	33
other	MILD IMBALANCE	Ear and labyrinth disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	1	59	1
other	HYPOTHYROIDISM	Endocrine disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	5	59	11
other	INCREASED TSH	Endocrine disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	1	59	1
other	BLURRED VISION	Eye disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	2	59	2
other	EYE PAIN	Eye disorders	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	1	59	1

1 to 10 of 187Source ClinicalTrials.gov

See all 187 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	1	59
Total, other adverse events	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	59	59
Total, serious adverse events	Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days	19	59

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36403579	DERIVED

Source PubMed

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
P30CA033572	Cancer Center Support Grant	CARPTEN, JOHN D.	BECKMAN RESEARCH INSTITUTE/CITY OF HOPE	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03057795

GET https://conductscience.org/api/trials/v1/NCT03057795/events?page=2

API reference For AI assistants