Trial Outcomes & Findings for Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (NCT NCT03075553)
NCT ID: NCT03075553
Last Updated: 2020-04-21
Results Overview
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.
TERMINATED
PHASE2
12 participants
Up to 390 days
2020-04-21
Participant Flow
Participant milestones
| Measure |
Treatment (Nivolumab)
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab)
n=12 Participants
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.
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|---|---|
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Age, Continuous
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65 years
n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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11 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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ECOG Performance Score
0
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7 Participants
n=5 Participants
|
|
ECOG Performance Score
1
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4 Participants
n=5 Participants
|
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ECOG Performance Score
2
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 390 daysThe 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.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=12 Participants
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.
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|---|---|
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Response Rate for Participants Who Achieve a CR or PR [CT-based Response]
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33.3 percentage of participants
Interval 12.3 to 63.7
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SECONDARY outcome
Timeframe: Up to 390 daysThe 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)
Outcome measures
| Measure |
Treatment (Nivolumab)
n=12 Participants
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.
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|---|---|
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Response Rate for Participants Who Achieve a CMR or PMR [PET-CT-based Response]
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33.3 percentage of participants
Interval 12.3 to 63.7
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SECONDARY outcome
Timeframe: Up to 390 daysPopulation: Participants who achieved a response are included in this analysis.
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.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=4 Participants
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.
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|---|---|
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Duration of Response (DOR)
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3.6 months
Interval 1.9 to 6.9
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SECONDARY outcome
Timeframe: The time from registration to relapse or death due to any cause, an average of 2 yearsThe 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)
Outcome measures
| Measure |
Treatment (Nivolumab)
n=12 Participants
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.
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|---|---|
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Progression-Free Survival (PFS)
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1.9 months
Interval 1.5 to 8.7
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SECONDARY outcome
Timeframe: The time from registration to death due to any cause, assessed up to 2 yearsThe distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=12 Participants
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.
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|---|---|
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Overall Survival (OS)
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7.9 months
Interval 3.4 to 10.8
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SECONDARY outcome
Timeframe: Up to 390 daysThe number of participants who experienced at least one grade 3 or higher adverse events are summarized below.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=12 Participants
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.
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|---|---|
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Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events
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6 Participants
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Adverse Events
Treatment (Nivolumab)
Serious adverse events
| Measure |
Treatment (Nivolumab)
n=12 participants at risk
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.
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|---|---|
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Cardiac disorders
Sinus tachycardia
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Gastrointestinal disorders
Jejunal perforation
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
|
Gastrointestinal disorders
Pancreatitis
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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General disorders
Fatigue
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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General disorders
Fever
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16.7%
2/12 • Number of events 2 • Up to 390 days
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Infections and infestations
Infections and infestations - Oth spec
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16.7%
2/12 • Number of events 3 • Up to 390 days
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Infections and infestations
Lung infection
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8.3%
1/12 • Number of events 1 • Up to 390 days
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Infections and infestations
Sepsis
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8.3%
1/12 • Number of events 1 • Up to 390 days
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Metabolism and nutrition disorders
Anorexia
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Metabolism and nutrition disorders
Dehydration
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Metabolism and nutrition disorders
Hypercalcemia
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8.3%
1/12 • Number of events 1 • Up to 390 days
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
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16.7%
2/12 • Number of events 2 • Up to 390 days
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Psychiatric disorders
Delirium
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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25.0%
3/12 • Number of events 3 • Up to 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Vascular disorders
Hypotension
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
Other adverse events
| Measure |
Treatment (Nivolumab)
n=12 participants at risk
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.
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|---|---|
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Blood and lymphatic system disorders
Anemia
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16.7%
2/12 • Number of events 3 • Up to 390 days
|
|
Gastrointestinal disorders
Abdominal pain
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16.7%
2/12 • Number of events 2 • Up to 390 days
|
|
Gastrointestinal disorders
Diarrhea
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50.0%
6/12 • Number of events 12 • Up to 390 days
|
|
Gastrointestinal disorders
Nausea
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8.3%
1/12 • Number of events 2 • Up to 390 days
|
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Gastrointestinal disorders
Vomiting
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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General disorders
Fatigue
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25.0%
3/12 • Number of events 4 • Up to 390 days
|
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General disorders
Fever
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Infections and infestations
Urinary tract infection
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Investigations
Lipase increased
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Investigations
Lymphocyte count decreased
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41.7%
5/12 • Number of events 9 • Up to 390 days
|
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Investigations
Neutrophil count decreased
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16.7%
2/12 • Number of events 3 • Up to 390 days
|
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Investigations
Platelet count decreased
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16.7%
2/12 • Number of events 3 • Up to 390 days
|
|
Investigations
Serum amylase increased
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
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Investigations
White blood cell decreased
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16.7%
2/12 • Number of events 2 • Up to 390 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
|
Metabolism and nutrition disorders
Hyponatremia
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8.3%
1/12 • Number of events 2 • Up to 390 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
|
Nervous system disorders
Headache
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8.3%
1/12 • Number of events 1 • Up to 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.7%
5/12 • Number of events 10 • Up to 390 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
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8.3%
1/12 • Number of events 3 • Up to 390 days
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
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16.7%
2/12 • Number of events 3 • Up to 390 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
6/12 • Number of events 16 • Up to 390 days
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place