NCT02181738 · CITED IN SOURCE DOCUMENTS

Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2023-11-28

The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B \& C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C

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outcome · POSTED

Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D

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outcome · POSTED

Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C

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outcome · POSTED

Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C

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outcome · POSTED

Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C

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outcome · POSTED

Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C

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outcome · POSTED

Duration of PR Based on IRRC Assessments in Cohorts A, B, and C

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outcome · POSTED

Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C

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outcome · POSTED

Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C

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outcome · POSTED

Treatment Discontinuation Rate in Cohort D

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outcome · POSTED

Number of Participants Who Died in Cohort D

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outcome · POSTED

Number of Participants With Adverse Events (AEs) in Cohort D

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outcome · POSTED

Number of Participants With Serious Adverse Events (SAEs) in Cohort D

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outcome · POSTED

Number of Participants With AEs Leading to Discontinuation in Cohort D

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outcome · POSTED

Number of Participants With AEs Leading to Dose Delay in Cohort D

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outcome · POSTED

Number of Participants With Select AEs in Cohort D

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outcome · POSTED

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase

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outcome · POSTED

Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase

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outcome · POSTED

Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase

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outcome · POSTED

Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase

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outcome · POSTED

Complete Response (CR) Rate at Planned End of Therapy Based on IRRC Assessments in Cohort D

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outcome · POSTED

Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C Extended Collection

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B \& C - enrollment closed) * Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B \& C - enrollment closed) * Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D) Exclusion Criteria: * Known central nervous system lymphoma * Participants with nodular lymphocyte-predominant Hodgkin Lymphoma * Prior allogeneic stem cell transplantation (SCT) * Chest radiation ≤ 24 weeks prior to first dose * Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Cohort (A, B, C): Nivolumab: Specified dose on specified days Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days
intervention Names
Drug: Nivolumab
Drug: Doxorubicin
Drug: Vinblastine
Drug: Dacarbazine
label
Nivolumab (Cohort A, B, C and D)
type
EXPERIMENTAL

interventions

arm Group Labels
Nivolumab (Cohort A, B, C and D)
description
Specified dose on specified days
name
Nivolumab
other Names
BMS-936558
type
DRUG
arm Group Labels
Nivolumab (Cohort A, B, C and D)
description
Specified dose on specified days
name
Doxorubicin
type
DRUG
arm Group Labels
Nivolumab (Cohort A, B, C and D)
description
Specified dose on specified days
name
Vinblastine
type
DRUG
arm Group Labels
Nivolumab (Cohort A, B, C and D)
description
Specified dose on specified days
name
Dacarbazine
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 294
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
measure
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)
description
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
measure
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
time Frame
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)

secondary Outcomes

description
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
measure
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).
description
The CR rate was defined as the percent of participants with a BOR of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
measure
Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
description
The duration of CR was only evaluated in participants with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression (Any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
measure
Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
description
The PR rate was defined as the percent of participants with a BOR of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
measure
Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
description
The duration of PR was only evaluated in participants with BOR of PR and was defined as the time from first documentation of PR (regression of measurable disease and no new sites) to the date of initial objectively documented progression (any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
measure
Duration of PR Based on IRRC Assessments in Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
description
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
measure
Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
description
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
measure
Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C
time Frame
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
description
Treatment discontinuation rate (TDR) is the number of treated participants who received \<4 doses of monotherapy or \<12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed. Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.
measure
Treatment Discontinuation Rate in Cohort D
time Frame
From first dose up until the date of treatment discontinuation (up to approximately 100 months).
description
Number of participants who died in Cohort D within 100 days after last dose of study therapy.
measure
Number of Participants Who Died in Cohort D
time Frame
From first dose of the considered therapy phase to 100 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 10 months up to a maximum of 13 months)
description
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
measure
Number of Participants With Adverse Events (AEs) in Cohort D
time Frame
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
measure
Number of Participants With Serious Adverse Events (SAEs) in Cohort D
time Frame
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
description
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
measure
Number of Participants With AEs Leading to Discontinuation in Cohort D
time Frame
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)

Full study description

brief Summary: The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B \& C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.

Source references

references

citation
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type
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citation
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pmid
27451390
type
DERIVED