Trial Outcomes & Findings for Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma (NCT NCT03484819)
NCT ID: NCT03484819
Last Updated: 2025-03-03
Results Overview
Will be estimated by the number of successes divided by the total number of evaluable patients. A success is defined as a patient that reports a confirmed complete or partial response according to Lugano criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
23 months
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\> \> Copanlisib Hydrochloride: Given IV\>
\> Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\> \> Copanlisib Hydrochloride: Given IV\>
\> Nivolumab: Given IV
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease Progression
|
4
|
|
Overall Study
Complicating Condition
|
1
|
Baseline Characteristics
Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=12 Participants
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\> \> Copanlisib Hydrochloride: Given IV\>
\> Nivolumab: Given IV
|
|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
ECOG Performance Status
0
|
3 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
6 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 23 monthsWill be estimated by the number of successes divided by the total number of evaluable patients. A success is defined as a patient that reports a confirmed complete or partial response according to Lugano criteria.
Outcome measures
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=12 Participants
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Copanlisib Hydrochloride: Given IV
\>
\> Nivolumab: Given IV
|
|---|---|
|
Objective Response Rate
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 monthsThe number of patients experiencing one or more grade 3+ adverse events will be reported.
Outcome measures
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=12 Participants
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Copanlisib Hydrochloride: Given IV
\>
\> Nivolumab: Given IV
|
|---|---|
|
Number of Grade 3+ Adverse Events
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 1 patient was not assessed for PFS because they did not have response and survival status evaluations.
Will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=11 Participants
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Copanlisib Hydrochloride: Given IV
\>
\> Nivolumab: Given IV
|
|---|---|
|
Progression Free Survival
|
2.9 months
Interval 2.1 to
The upper end of the 95% CI was not estimatable due to low numbers of patients with events
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 4/12 patients are included for DOR as only 4 patients reported a response to treatment
Will be estimated using the method of Kaplan-Meier. Patients reporting a confirmed or unconfirmed, partial or complete response are included in analysis.
Outcome measures
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=4 Participants
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Copanlisib Hydrochloride: Given IV
\>
\> Nivolumab: Given IV
|
|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 2.8 to
The median and upper end of the 95% CI were not estimatable due to low numbers of patients with events
|
SECONDARY outcome
Timeframe: 24 monthsWill be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=12 Participants
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Copanlisib Hydrochloride: Given IV
\>
\> Nivolumab: Given IV
|
|---|---|
|
Overall Survival Time
|
13.2 months
Interval 3.6 to
The upper end of the 95% CI was not estimatable due to low numbers of patients with events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5.5 yearsOutcome measures
Outcome data not reported
Adverse Events
Treatment (Copanlisib Hydrochloride, Nivolumab)
Serious events: 10 serious events
Other events: 12 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=12 participants at risk
Nivolumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
4/12 • Number of events 4 • 24 months
|
|
Cardiac disorders
Atrial flutter
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Cardiac disorders
Cardiac arrest
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Ileus
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
General disorders
Disease progression
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Investigations
Neutrophil count decreased
|
25.0%
3/12 • Number of events 4 • 24 months
|
|
Investigations
White blood cell decreased
|
25.0%
3/12 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
2/12 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 3 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Nervous system disorders
Encephalopathy
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 2 • 24 months
|
|
Vascular disorders
Hypertension
|
33.3%
4/12 • Number of events 4 • 24 months
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Treatment (Copanlisib Hydrochloride, Nivolumab)
n=12 participants at risk
Nivolumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
4/12 • Number of events 37 • 24 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
1/12 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Bloating
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 6 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
4/12 • Number of events 20 • 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Ileus
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
8.3%
1/12 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
6/12 • Number of events 20 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Number of events 3 • 24 months
|
|
General disorders
Edema limbs
|
25.0%
3/12 • Number of events 14 • 24 months
|
|
General disorders
Fatigue
|
33.3%
4/12 • Number of events 26 • 24 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
16.7%
2/12 • Number of events 23 • 24 months
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Immune system disorders
Allergic reaction
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Infections and infestations
Bronchial infection
|
8.3%
1/12 • Number of events 2 • 24 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Number of events 4 • 24 months
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
2/12 • Number of events 3 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
3/12 • Number of events 5 • 24 months
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
2/12 • Number of events 4 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
3/12 • Number of events 4 • 24 months
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.3%
1/12 • Number of events 7 • 24 months
|
|
Investigations
Creatinine increased
|
25.0%
3/12 • Number of events 24 • 24 months
|
|
Investigations
Investigations - Other, specify
|
16.7%
2/12 • Number of events 7 • 24 months
|
|
Investigations
Lipase increased
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Investigations
Lymphocyte count decreased
|
58.3%
7/12 • Number of events 31 • 24 months
|
|
Investigations
Neutrophil count decreased
|
33.3%
4/12 • Number of events 10 • 24 months
|
|
Investigations
Platelet count decreased
|
33.3%
4/12 • Number of events 16 • 24 months
|
|
Investigations
Weight loss
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Investigations
White blood cell decreased
|
41.7%
5/12 • Number of events 22 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
3/12 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.7%
5/12 • Number of events 37 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
3/12 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
3/12 • Number of events 5 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
2/12 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
2/12 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
41.7%
5/12 • Number of events 8 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
4/12 • Number of events 7 • 24 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
3/12 • Number of events 6 • 24 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
16.7%
2/12 • Number of events 29 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 3 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
3/12 • Number of events 9 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
8.3%
1/12 • Number of events 21 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 21 • 24 months
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 5 • 24 months
|
|
Nervous system disorders
Neuralgia
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
16.7%
2/12 • Number of events 3 • 24 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
16.7%
2/12 • Number of events 8 • 24 months
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.3%
1/12 • Number of events 3 • 24 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
4/12 • Number of events 7 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
8.3%
1/12 • Number of events 2 • 24 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
3/12 • Number of events 34 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
1/12 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
8.3%
1/12 • Number of events 4 • 24 months
|
|
Vascular disorders
Hypertension
|
25.0%
3/12 • Number of events 7 • 24 months
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60