TriangleNCT03075553 · STUDY IN CONTEXT
Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to \<=1.5 cm in longest transverse diameter (LDi). Partial response (PR): \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
The response rate for participants who achieve a CMR or PMR is defined as the percentage of participants who achieve a CMR or PMR assessed according to the revised Lugano Classification Response criteria. Complete metabolic response (CMR): Score 1, 2, or 3 with/without a residual mass using the Lugano 5-Point Scale (5-PS). Partial metabolic response (PMR): Score 4 or 5 with reduced update from baseline. The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)
The distribution of duration of response (CR or PR) will be estimated using the method of Kaplan-Meier. Complete response (CR): target nodes/nodal masses must regress to \<=1.5 cm in longest transverse diameter (LDi). Partial response (PR): \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate will be reported. progressive disease (PD): a Lugano score of 4 to 5 with increasing intensity compared to baseline or any interim scan and/or any new FDG-avid focus consistent with malignant lymphoma.The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)
The distribution of survival time will be estimated using the method of Kaplan-Meier.
The number of participants who experienced at least one grade 3 or higher adverse events are summarized below.
Reported safety
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-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- trial label
- Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0000
- source section id
- NCT03075553-om-0000
- source outcome index
- 0
- endpoint
- Response Rate for Participants Who Achieve a CR or PR [CT-based Response]
- endpoint definition
- The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to \<=1.5 cm in longest transverse diameter (LDi). Partial response (PR): \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
- time origin
- Up to 390 days
- analysis role
- primary
- reporting status
- 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-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0001
- source section id
- NCT03075553-om-0001
- source outcome index
- 1
- endpoint
- Response Rate for Participants Who Achieve a CMR or PMR [PET-CT-based Response]
- endpoint definition
- The response rate for participants who achieve a CMR or PMR is defined as the percentage of participants who achieve a CMR or PMR assessed according to the revised Lugano Classification Response criteria. Complete metabolic response (CMR): Score 1, 2, or 3 with/without a residual mass using the Lugano 5-Point Scale (5-PS). Partial metabolic response (PMR): Score 4 or 5 with reduced update from baseline. The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)
- time origin
- Up to 390 days
- analysis role
- secondary
- reporting status
- 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-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0002
- source section id
- NCT03075553-om-0002
- source outcome index
- 2
- endpoint
- Duration of Response (DOR)
- endpoint definition
- The distribution of duration of response (CR or PR) will be estimated using the method of Kaplan-Meier. Complete response (CR): target nodes/nodal masses must regress to \<=1.5 cm in longest transverse diameter (LDi). Partial response (PR): \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
- time origin
- Up to 390 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who achieved a response are included in this analysis.
- 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-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0003
- source section id
- NCT03075553-om-0003
- source outcome index
- 3
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate will be reported. progressive disease (PD): a Lugano score of 4 to 5 with increasing intensity compared to baseline or any interim scan and/or any new FDG-avid focus consistent with malignant lymphoma.The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)
- time origin
- The time from registration to relapse or death due to any cause, an average of 2 years
- analysis role
- secondary
- reporting status
- 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-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0004
- source section id
- NCT03075553-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival (OS)
- endpoint definition
- The distribution of survival time will be estimated using the method of Kaplan-Meier.
- time origin
- The time from registration to death due to any cause, assessed up to 2 years
- analysis role
- secondary
- reporting status
- 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-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0005
- source section id
- NCT03075553-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events
- endpoint definition
- The number of participants who experienced at least one grade 3 or higher adverse events are summarized below.
- time origin
- Up to 390 days
- analysis role
- secondary
- reporting status
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Nivolumab)
- regimen
- Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03075553-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Nivolumab)
- regimen
- Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03075553-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Nivolumab)
- regimen
- Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03075553-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Nivolumab)
- regimen
- Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03075553-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Nivolumab)
- regimen
- Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03075553-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Nivolumab)
- regimen
- Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03075553-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-recurrent-270902ab
- nct id
- NCT03075553
- harm key
- EG000
- source section id
- NCT03075553-ae
- event group key
- EG000
- event group label
- Treatment (Nivolumab)
- serious affected
- 5
- serious at risk
- 12
- other affected
- 10
- other at risk
- 12
- frequency threshold
- 0
- collection period
- Up to 390 days
- 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