Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · NOT_POSTED

Will be assessed by immunohistochemistry. Will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (Wilcoxon signed rank and McNemar's tests) will be used to assess changes in these variables before and after therapy. In addition, baseline values and changes over time in each measure will be explored in relation to clinical outcome. Differences between responders and non-responders will be assessed using Wilcoxon's rank sum (continuous data) or Fisher's exact (categorical data) test. The relationship between each measure and time to event measures (PFS, overall survival \[OS\]) will be evaluated using Cox's proportional hazards models and log-rank tests. Logistic regression will be used to model the response rate as a function of treatment and CD27 (as a continuous variable). The distribution of CD27 will be estimated empirically in the entire trial population and used to calculate CD27 values corresponding to each fixed percentile.

Source null

→

primary · POSTED

Will be assessed by computed tomography (CT)-based criteria or positron emission tomography (PET)-CT based criteria. A response will be defined as an objective status of partial remission (PR) or complete remission (CR) for patients evaluated by CT-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) for patients evaluated by PET-CT based criteria. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in each arm. Comparison of overall response rates between the two treatment groups will be performed using a one-sided Fisher's exact test at significance level 0.15.

All eligible patients that had a disease evaluation after being treated.

→

secondary · POSTED

Defined as the date at which the patient's objective status is first noted to be a PR or CR for patients evaluated by CT-based criteria or CMR or PMR for patients evaluated by PET-CT based criteria to the earliest date progression (documentation of disease progression \[PMD\] or progressive disease \[PD\]) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test.

All eligible and treated patients that achieve a response.

→

secondary · POSTED

The distribution of survival time will be estimated using the method of Kaplan-Meier. The comparison of overall survival between two treatment arms will be based on the log-rank test.

All eligible and treated patients.

→

secondary · POSTED

The distribution of PFS will be estimated using the method of Kaplan-Meier. The comparison of progression-free survival between two treatment arms will be based on the log-rank test.

All eligible and treated patients that had a disease evaluation.

→

secondary · POSTED

Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The overall adverse event rates for grade 3 or higher hematologic and non-hematologic adverse events at least possibly related to treatment will be compared between the two treatment groups using the Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).

All eligible and treated patients.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id: NCT03038672
trial label: Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0005
source section id
NCT03038672-om-0005
source outcome index
5
endpoint
Change in CD27 Expression in Tissue
endpoint definition
Will be assessed by immunohistochemistry. Will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (Wilcoxon signed rank and McNemar's tests) will be used to assess changes in these variables before and after therapy. In addition, baseline values and changes over time in each measure will be explored in relation to clinical outcome. Differences between responders and non-responders will be assessed using Wilcoxon's rank sum (continuous data) or Fisher's exact (categorical data) test. The relationship between each measure and time to event measures (PFS, overall survival \[OS\]) will be evaluated using Cox's proportional hazards models and log-rank tests. Logistic regression will be used to model the response rate as a function of treatment and CD27 (as a continuous variable). The distribution of CD27 will be estimated empirically in the entire trial population and used to calculate CD27 values corresponding to each fixed percentile.
time origin
Baseline up to 100 days after last dose of study drug
analysis role
exploratory
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0000
source section id
NCT03038672-om-0000
source outcome index
0
endpoint
Overall Response Rate
endpoint definition
Will be assessed by computed tomography (CT)-based criteria or positron emission tomography (PET)-CT based criteria. A response will be defined as an objective status of partial remission (PR) or complete remission (CR) for patients evaluated by CT-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) for patients evaluated by PET-CT based criteria. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in each arm. Comparison of overall response rates between the two treatment groups will be performed using a one-sided Fisher's exact test at significance level 0.15.
time origin
2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients that had a disease evaluation after being treated.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0001
source section id
NCT03038672-om-0001
source outcome index
1
endpoint
Duration of Response
endpoint definition
Defined as the date at which the patient's objective status is first noted to be a PR or CR for patients evaluated by CT-based criteria or CMR or PMR for patients evaluated by PET-CT based criteria to the earliest date progression (documentation of disease progression \[PMD\] or progressive disease \[PD\]) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test.
time origin
2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible and treated patients that achieve a response.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0002
source section id
NCT03038672-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
The distribution of survival time will be estimated using the method of Kaplan-Meier. The comparison of overall survival between two treatment arms will be based on the log-rank test.
time origin
37 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible and treated patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0003
source section id
NCT03038672-om-0003
source outcome index
3
endpoint
Progression Free Survival (PFS)
endpoint definition
The distribution of PFS will be estimated using the method of Kaplan-Meier. The comparison of progression-free survival between two treatment arms will be based on the log-rank test.
time origin
37 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible and treated patients that had a disease evaluation.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0004
source section id
NCT03038672-om-0004
source outcome index
4
endpoint
Proportion of Patients With Grade 3 or Higher Adverse Events
endpoint definition
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The overall adverse event rates for grade 3 or higher hematologic and non-hematologic adverse events at least possibly related to treatment will be compared between the two treatment groups using the Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).
time origin
25 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible and treated patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0000
arm key
OG000
arm label
Group I (Nivolumab)
regimen
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0000
arm key
OG001
arm label
Group II (Varlilumab, Nivolumab)
regimen
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0001
arm key
OG000
arm label
Group I (Nivolumab)
regimen
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0001
arm key
OG001
arm label
Group II (Varlilumab, Nivolumab)
regimen
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0002
arm key
OG000
arm label
Group I (Nivolumab)
regimen
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0002
arm key
OG001
arm label
Group II (Varlilumab, Nivolumab)
regimen
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0003
arm key
OG000
arm label
Group I (Nivolumab)
regimen
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0003
arm key
OG001
arm label
Group II (Varlilumab, Nivolumab)
regimen
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0004
arm key
OG000
arm label
Group I (Nivolumab)
regimen
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
outcome key
om-0004
arm key
OG001
arm label
Group II (Varlilumab, Nivolumab)
regimen
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03038672-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
harm key
EG000
source section id
NCT03038672-ae
event group key
EG000
event group label
Group I (Nivolumab)
serious affected
10
serious at risk
27
other affected
24
other at risk
27
frequency threshold
0
collection period
25 months for adverse events and 37 months for mortality
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
harm key
EG001
source section id
NCT03038672-ae
event group key
EG001
event group label
Group II (Varlilumab, Nivolumab)
serious affected
12
serious at risk
27
other affected
24
other at risk
27
frequency threshold
0
collection period
25 months for adverse events and 37 months for mortality
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-t-cell-histiocyte-rich-large-b-cell-lymphoma
nct id
NCT03038672
harm key
EG002
source section id
NCT03038672-ae
event group key
EG002
event group label
Cross Over to Group II Treatment (Varlilumab, Nivolumab)
serious affected
3
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
25 months for adverse events and 37 months for mortality
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice