Trial Outcomes & Findings for Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma (NCT NCT02631746)

NCT ID: NCT02631746

Last Updated: 2025-03-14

Results Overview

Toxicity by grade will be summarized using descriptive statistics. The incidence of toxicities will be estimated using the binomial proportion and its 90% confidence interval.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2025-03-14

Participant Flow

Participant milestones

Measure	Treatment (Nivolumab) Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacogenomic Study: Correlative studies
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Treatment (Nivolumab) Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacogenomic Study: Correlative studies
Overall Study Lack of Efficacy	3

Baseline Characteristics

Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma

Baseline characteristics by cohort

Measure	Treatment (Nivolumab) n=3 Participants Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacogenomic Study: Correlative studies
Age, Continuous	51 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Toxicity by grade will be summarized using descriptive statistics. The incidence of toxicities will be estimated using the binomial proportion and its 90% confidence interval.

Outcome measures

Measure	Treatment (Nivolumab) n=3 Participants Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacogenomic Study: Correlative studies
Incidence of Adverse Events of Nivolumab, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	3 Participants

PRIMARY outcome

Timeframe: 1 year

Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy.

Outcome measures

Measure	Treatment (Nivolumab) n=3 Participants Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacogenomic Study: Correlative studies
Tumor Response, Evaluated Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors Guideline (Version 1.1)	0 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Duration of response cannot be calculated because of no responders.

Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy. The Kaplan-Meier method will be used to evaluate the response duration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Post-treatment data not available because no patients made it to Cycle 3 Day 1.

Analysis of variance methods will be used to evaluate the effects of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Post-treatment data not available because no patients made it to Cycle 3 Day 1.

Analysis of variance methods will be used to evaluate the effects of treatment and time on the viral load measurements, as well as measurements of viral transcripts. A proportional hazards analysis with viral load measures as time dependent covariates will be used to evaluate the effects of these measures on duration of response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Post-treatment data not available because no patients made it to Cycle 3 Day 1.

Measured from peripheral blood mononuclear cell (PBMC) samples.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Post-treatment data not available because no patients made it to Cycle 3 Day 1.

Measured from PBMC samples.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Post-treatment data not available because no patients made it to Cycle 3 Day 1.

Measured from blood and tissue samples.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Nivolumab)

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Nivolumab) n=3 participants at risk Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacogenomic Study: Correlative studies
Gastrointestinal disorders Abdominal Pain	33.3% 1/3 • 1 year
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • 1 year
Investigations Alanine aminotransferase increased	33.3% 1/3 • 1 year
Investigations Aspartate aminotransferase increased	66.7% 2/3 • 1 year
Metabolism and nutrition disorders Hypercalcemia	66.7% 2/3 • 1 year
Blood and lymphatic system disorders Splenomegaly/splenic infarct	33.3% 1/3 • 1 year

Other adverse events

Measure	Treatment (Nivolumab) n=3 participants at risk Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacogenomic Study: Correlative studies
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • 1 year
Investigations Alanine aminotransferase increased	33.3% 1/3 • 1 year
Investigations Alkaline phosphatase increased	33.3% 1/3 • 1 year
Blood and lymphatic system disorders Anemia	33.3% 1/3 • 1 year
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • 1 year
Investigations Blood bilirubin increased	33.3% 1/3 • 1 year
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • 1 year
Investigations Creatinine increased	33.3% 1/3 • 1 year
General disorders Fatigue	33.3% 1/3 • 1 year
General disorders Fever	33.3% 1/3 • 1 year
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • 1 year
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • 1 year
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • 1 year
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • 1 year
Investigations INR increased	33.3% 1/3 • 1 year
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • 1 year
Gastrointestinal disorders Nausea	33.3% 1/3 • 1 year
Investigations Neutrophil count decreased	33.3% 1/3 • 1 year
Investigations Platelet count decreased	33.3% 1/3 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary edema	33.3% 1/3 • 1 year
Cardiac disorders Sinus tachycardia	33.3% 1/3 • 1 year
Gastrointestinal disorders Vomiting	33.3% 1/3 • 1 year

Additional Information

Christy Arrowood

Duke University - Duke Cancer Institute LAO

Phone: 919-613-6130

Email: christy.arrowood@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60