Trial Outcomes & Findings for Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma (NCT NCT02535247)

NCT ID: NCT02535247

Last Updated: 2022-07-08

Results Overview

Based on RECIST v1.1

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

3 Months

Results posted on

2022-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles MK-3475	Combination MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study MK-3475 Copanlisib
Overall Study STARTED	17	0
Overall Study COMPLETED	13	0
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=17 Participants MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles MK-3475	Combination MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study MK-3475 Copanlisib	Total n=17 Participants Total of all reporting groups
Age, Continuous	71 years n=17 Participants	—	71 years n=17 Participants
Sex: Female, Male Female	9 Participants n=17 Participants	0 Participants	9 Participants n=17 Participants
Sex: Female, Male Male	8 Participants n=17 Participants	0 Participants	8 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	—	17 participants n=17 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: Some patients unevaluable for PFS

Based on RECIST v1.1

Outcome measures

Outcome measures
Measure	Treatment n=11 Participants MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles MK-3475	Combination MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study MK-3475 Copanlisib
Progression Free Survival	6 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: Study did not progress to portion with combination of pembrolizumab and copanlisib

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Study did not progress to portion with combination of pembrolizumab and copanlisib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Months

Population: Study did not progress to portion with combination of pembrolizumab and copanlisib

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles MK-3475	Combination MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study MK-3475 Copanlisib
Overall Survival	3.2 months Interval 1.2 to 3.7	—

SECONDARY outcome

Timeframe: 6 months

Population: Maximum tolerated dose data not available because this data was not collected

Defined as the highest dose tested in which none or only one patient experienced dose-limiting toxicity (DLT) attributable to the study drug(s), when 6 patients have been treated at that dose and are evaluable for toxicity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data was not collected as the trial was halted early after a preplanned interim futility analysis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 3

Population: Data was not collected as the trial was halted early after a preplanned interim futility analysis

PD-1 expression and leukocyte activation markers on circulating lymphocytes pre-treatment, at weeks 3 and 6, and at time of disease progression

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 6

Population: Data was not collected as the trial was halted early after a preplanned interim futility analysis

PD-1 expression and leukocyte activation markers on circulating lymphocytes pre-treatment, at weeks 3 and 6, and at time of disease progression

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 12 serious events

Other events: 17 other events

Deaths: 11 deaths

Combination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Protocol Development Coordinator

Fox Chase Cancer Center

Phone: 215-728-4097

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment n=17 participants at risk MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles MK-3475	Combination MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study MK-3475 Copanlisib
Gastrointestinal disorders Abdominal distension	11.8% 2/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Gastrointestinal disorders Abdominal pain	23.5% 4/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Endocrine disorders Adrenal insufficiency	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Gastrointestinal disorders Ascites	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Gastrointestinal disorders Intractable vomiting	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Vascular disorders Hypotension	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Infections and infestations Methicillin-Resistant Staphyloccus aureus infection	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Infections and infestations Lung infection	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
General disorders Fever	23.5% 4/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Infections and infestations Sepsis	11.8% 2/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Renal and urinary disorders Renal Insufficiency	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Infections and infestations Bilateral pneumonia	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Vascular disorders Vasculitis	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Skin and subcutaneous tissue disorders Wound	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Blood and lymphatic system disorders Thrombocytopenia	11.8% 2/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Gastrointestinal disorders Colitis	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Gastrointestinal disorders Neutropenic fever	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Gastrointestinal disorders Fecal impaction	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
Skin and subcutaneous tissue disorders Maculo-papular rash	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.
General disorders Death NOS	5.9% 1/17 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.	— 0/0 • 2 years Study did not progress to portion with combination of pembrolizumab and copanlisib.