Trial Outcomes & Findings for Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies (NCT NCT04205409)

NCT ID: NCT04205409

Last Updated: 2025-11-03

Results Overview

Assessed by disease-specific guidelines: multiple myeloma - International Myeloma Working Group response criteria, non-Hodgkin lymphoma - Response assessment will be based on the Lugano Criteria, and chronic lymphocytic leukemia - Response assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria. ORR will be estimated, and its corresponding 95% exact binomial confidence interval (CI) will be provided.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Up to 1 year 8 months

Results posted on

2025-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (nivolumab) Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (nivolumab) n=20 Participants Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=3 Participants
Age, Categorical >=65 years	8 Participants n=3 Participants
Age, Continuous	61 years n=3 Participants
Sex: Female, Male Female	6 Participants n=3 Participants
Sex: Female, Male Male	14 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants
Race (NIH/OMB) Asian	2 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants
Race (NIH/OMB) White	17 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=3 Participants
Region of Enrollment United States	20 participants n=3 Participants

PRIMARY outcome

Timeframe: Up to 1 year 8 months

Outcome measures

Outcome measures
Measure	Treatment (nivolumab) n=20 Participants Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Best Overall Response Rate (ORR)	2 Participants

SECONDARY outcome

Timeframe: From the first study drug administration to death from any cause, up to 5 years

Will employ Kaplan-Meier and Cox proportional hazard model methodology.

Outcome measures

Outcome measures
Measure	Treatment (nivolumab) n=20 Participants Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Overall Survival	8 Participants

SECONDARY outcome

Timeframe: From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years

Will employ Kaplan-Meier and Cox proportional hazard model methodology.

Outcome measures

Outcome measures
Measure	Treatment (nivolumab) n=20 Participants Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Progression-free Survival	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Will employ Kaplan-Meier and Cox proportional hazard model methodology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after the last dose of study drug, up to a maximum of 1 year 9 months

Will be determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Safety data will be summarized descriptively. Adverse events will be summarized by severity, seriousness, and relationship to study drug.

Outcome measures

Outcome measures
Measure	Treatment (nivolumab) n=20 Participants Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Incidence of Adverse Events	20 Participants

Adverse Events

Treatment (nivolumab)

Serious events: 10 serious events

Other events: 18 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (nivolumab) n=20 participants at risk Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Cardiac disorders Atrial fibrillation with RVR	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Blood and lymphatic system disorders Anemia	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Cardiac disorders Cardiac arrest	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Cardiac disorders Chest pain	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
General disorders Disease progression	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
General disorders Febrile neutropenia	10.0% 2/20 • Number of events 3 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
General disorders Fever	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Renal and urinary disorders Hematuria	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Vascular disorders Hypotension	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Infections and infestations Lung infection	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Infections and infestations Pneumonitis	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Infections and infestations Sepsis	15.0% 3/20 • Number of events 5 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.

Other adverse events

Other adverse events
Measure	Treatment (nivolumab) n=20 participants at risk Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Renal and urinary disorders Chronic kidney disease	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Diarrhea	25.0% 5/20 • Number of events 6 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Nervous system disorders Dizziness	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
General disorders Fatigue	30.0% 6/20 • Number of events 6 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Fecal incontinence	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
General disorders Fever	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
General disorders Flu like symptoms	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Vascular disorders Flushing	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Gas	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Gastroenteritis	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Nervous system disorders Headache	15.0% 3/20 • Number of events 3 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Vascular disorders Hypertension	5.0% 1/20 • Number of events 4 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Metabolism and nutrition disorders Hypokalemia	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Metabolism and nutrition disorders Hypomagnesemia	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Vascular disorders Hypotension	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Injury, poisoning and procedural complications Infusion related reaction	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Oral hemorrhage	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Mucositis oral	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 2/20 • Number of events 3 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Nausea	25.0% 5/20 • Number of events 6 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Neck pain	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Investigations Neutrophil count decreased	30.0% 6/20 • Number of events 10 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Oral pain	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Myalgia	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Skin and subcutaneous tissue disorders Fragility	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
General disorders Pain	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Nervous system disorders Peripheral neuropathy	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Investigations Platelet count decreased	20.0% 4/20 • Number of events 8 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Infections and infestations Pleural infection	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Skin and subcutaneous tissue disorders Pruritus	15.0% 3/20 • Number of events 3 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Respiratory depression	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Shortness of breath	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Infections and infestations Sinusitis	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Small intestinal bacterial overgrowth	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Sore throat	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Steatorrhea	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Infections and infestations Upper respiratory infection	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Eye disorders Watering eyes	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Investigations White blood cell decreased	20.0% 4/20 • Number of events 4 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Jaw pain	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Eye disorders Vision decreased	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Respiratory, thoracic and mediastinal disorders Pharyngeal congestoin	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Blood and lymphatic system disorders Anemia	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Cardiac disorders Atrial flutter	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Gastrointestinal disorders Bloating	10.0% 2/20 • Number of events 2 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Eye disorders Blurred vision	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Body aches	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Musculoskeletal and connective tissue disorders Bone pain	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
Injury, poisoning and procedural complications Bruising	5.0% 1/20 • Number of events 1 • Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.

Additional Information

Dr. Andrew Cowan

University of Washington

Phone: 2066067348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place