Trial Outcomes & Findings for MK-3475 in Combination With Docetaxel vs Docetaxel Alone in Non-Small Cell Lung Cancer Patients (NCT NCT02574598)

Last Updated: 2021-01-06

Results Overview

The objective response rate (ORR) per response evaluation criteria in solit tumors (RECIST v1.1) was defined as the sum of complete response or partial response assessed by RECIST (v1.1) and is presented as the percent of participants with 95% Confidence Intervals (CI). Complete response (CR) was considered if there was a dissapearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. Partial response (PR) was considered if there was at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

from baseline to 2 months of treatment

Results posted on

2021-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel + MK-3475 Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles MK-3475 (200mg, Day 8, every 3 weeks), followed by maintenance therapy with MK-3475 until disease progression or unacceptable toxicity.	Docetaxel Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles.
Overall Study STARTED	40	38
Overall Study COMPLETED	40	38
Overall Study NOT COMPLETED	0	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	Docetaxel + MK-3475 n=40 Participants Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles MK-3475 (200mg, Day 8, every 3 weeks), followed by maintenance therapy with MK-3475 until disease progression or unacceptable toxicity.	Docetaxel n=38 Participants Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles.	Total n=78 Participants Total of all reporting groups
Age, Continuous	50.1 Years STANDARD_DEVIATION 13.2 • n=40 Participants	62.1 Years STANDARD_DEVIATION 11.6 • n=38 Participants	60.01 Years STANDARD_DEVIATION 12.5 • n=78 Participants
Sex: Female, Male Female	21 Participants n=40 Participants	25 Participants n=38 Participants	46 Participants n=78 Participants
Sex: Female, Male Male	19 Participants n=40 Participants	13 Participants n=38 Participants	32 Participants n=78 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Mexico	40 participants n=40 Participants	38 participants n=38 Participants	78 participants n=78 Participants

PRIMARY outcome

Timeframe: from baseline to 2 months of treatment

Outcome measures

Outcome measures
Measure	Docetaxel + MK-3475 n=40 Participants Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles MK-3475 (200mg, Day 8, every 3 weeks), followed by maintenance therapy with MK-3475 until disease progression or unacceptable toxicity.	Docetaxel n=38 Participants Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles.
Overall Response Rate	42.5 percentage of responders Interval 26.9 to 58.1	15.8 percentage of responders Interval 4.0 to 27.6

Adverse Events

Docetaxel + MK-3475

Serious events: 5 serious events

Other events: 37 other events

Deaths: 21 deaths

Docetaxel

Serious events: 3 serious events

Other events: 35 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel + MK-3475 n=40 participants at risk Docetaxel 75 mg/m2 every 3 weeks until progression of disease MK-3475 (administered on day 8) 200mg every 3 until progression of disease MK-3475: The dosing interval of pembrolizumab can be increased in case of toxicity. Docetaxel: Use on both arms as standard of care.	Docetaxel n=38 participants at risk Docetaxel 75 mg/m2 every 3 weeks until progression of disease followed by MK-3475 200mg every 3 until progression of disease MK-3475: The dosing interval of pembrolizumab can be increased in case of toxicity. Docetaxel: Use on both arms as standard of care.
General disorders Fatigue	5.0% 2/40 • Number of events 2 • 1 year All adverse events were recorded during each clinical visit	5.3% 2/38 • Number of events 2 • 1 year All adverse events were recorded during each clinical visit
Blood and lymphatic system disorders Lymphopenia	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
Blood and lymphatic system disorders Hyponatremia	0.00% 0/40 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Endocrine disorders Hypothiroidism	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
Hepatobiliary disorders Hepatitis	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit

Other adverse events

Additional Information

Dr. Oscar Arrieta

Instituto Nacional de Cancerología

Phone: (52) 55-5628-0400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Docetaxel + MK-3475 n=40 participants at risk Docetaxel 75 mg/m2 every 3 weeks until progression of disease MK-3475 (administered on day 8) 200mg every 3 until progression of disease MK-3475: The dosing interval of pembrolizumab can be increased in case of toxicity. Docetaxel: Use on both arms as standard of care.	Docetaxel n=38 participants at risk Docetaxel 75 mg/m2 every 3 weeks until progression of disease followed by MK-3475 200mg every 3 until progression of disease MK-3475: The dosing interval of pembrolizumab can be increased in case of toxicity. Docetaxel: Use on both arms as standard of care.
Endocrine disorders Hyponatremia	10.0% 4/40 • Number of events 4 • 1 year All adverse events were recorded during each clinical visit	10.5% 4/38 • Number of events 4 • 1 year All adverse events were recorded during each clinical visit
Skin and subcutaneous tissue disorders Edema	10.0% 4/40 • Number of events 4 • 1 year All adverse events were recorded during each clinical visit	5.3% 2/38 • Number of events 2 • 1 year All adverse events were recorded during each clinical visit
Metabolism and nutrition disorders Dysgeusia	10.0% 4/40 • Number of events 4 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Musculoskeletal and connective tissue disorders Myalgia	7.5% 3/40 • Number of events 3 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
Blood and lymphatic system disorders Thrombocytopenia	5.0% 2/40 • Number of events 2 • 1 year All adverse events were recorded during each clinical visit	7.9% 3/38 • Number of events 3 • 1 year All adverse events were recorded during each clinical visit
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Blood and lymphatic system disorders Hypercalcemia	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Hepatobiliary disorders Hyperbilirrubinemia	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Skin and subcutaneous tissue disorders Hand Foot Syndrome	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
Eye disorders Lacrimal obstruction	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
General disorders Paronychia	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
General disorders Hypomagnesemia	0.00% 0/40 • 1 year All adverse events were recorded during each clinical visit	18.4% 7/38 • Number of events 7 • 1 year All adverse events were recorded during each clinical visit
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/40 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Endocrine disorders Hypothiroidism	27.5% 11/40 • Number of events 11 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Respiratory, thoracic and mediastinal disorders Pneumonitis	22.5% 9/40 • Number of events 9 • 1 year All adverse events were recorded during each clinical visit	5.3% 2/38 • Number of events 2 • 1 year All adverse events were recorded during each clinical visit
Hepatobiliary disorders Hepatitis	17.5% 7/40 • Number of events 7 • 1 year All adverse events were recorded during each clinical visit	10.5% 4/38 • Number of events 4 • 1 year All adverse events were recorded during each clinical visit
Endocrine disorders Hyperthiroidism	7.5% 3/40 • Number of events 3 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
Immune system disorders Xerostomy	5.0% 2/40 • Number of events 2 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Renal and urinary disorders Nephritis	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	2.6% 1/38 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit
Eye disorders Sjogren	2.5% 1/40 • Number of events 1 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
Gastrointestinal disorders Nausea	52.5% 21/40 • Number of events 21 • 1 year All adverse events were recorded during each clinical visit	47.4% 18/38 • Number of events 18 • 1 year All adverse events were recorded during each clinical visit
Gastrointestinal disorders Diarrhea	47.5% 19/40 • Number of events 19 • 1 year All adverse events were recorded during each clinical visit	50.0% 19/38 • Number of events 19 • 1 year All adverse events were recorded during each clinical visit
Nervous system disorders Neuropathy	40.0% 16/40 • Number of events 16 • 1 year All adverse events were recorded during each clinical visit	47.4% 18/38 • Number of events 18 • 1 year All adverse events were recorded during each clinical visit
Blood and lymphatic system disorders Neutropenia	40.0% 16/40 • Number of events 16 • 1 year All adverse events were recorded during each clinical visit	39.5% 15/38 • Number of events 15 • 1 year All adverse events were recorded during each clinical visit
Skin and subcutaneous tissue disorders Alopecia	25.0% 10/40 • Number of events 10 • 1 year All adverse events were recorded during each clinical visit	21.1% 8/38 • Number of events 8 • 1 year All adverse events were recorded during each clinical visit
Gastrointestinal disorders Vomiting	22.5% 9/40 • Number of events 9 • 1 year All adverse events were recorded during each clinical visit	23.7% 9/38 • Number of events 9 • 1 year All adverse events were recorded during each clinical visit
Metabolism and nutrition disorders Hyporexia	20.0% 8/40 • Number of events 8 • 1 year All adverse events were recorded during each clinical visit	21.1% 8/38 • Number of events 8 • 1 year All adverse events were recorded during each clinical visit
Blood and lymphatic system disorders Lymphopenia	20.0% 8/40 • Number of events 8 • 1 year All adverse events were recorded during each clinical visit	0.00% 0/38 • 1 year All adverse events were recorded during each clinical visit
General disorders Mucositis	17.5% 7/40 • Number of events 7 • 1 year All adverse events were recorded during each clinical visit	10.5% 4/38 • Number of events 4 • 1 year All adverse events were recorded during each clinical visit
Gastrointestinal disorders Constipation	15.0% 6/40 • Number of events 6 • 1 year All adverse events were recorded during each clinical visit	10.5% 4/38 • Number of events 4 • 1 year All adverse events were recorded during each clinical visit
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 5/40 • Number of events 5 • 1 year All adverse events were recorded during each clinical visit	7.9% 3/38 • Number of events 3 • 1 year All adverse events were recorded during each clinical visit
General disorders Fatigue	65.0% 26/40 • Number of events 26 • 1 year All adverse events were recorded during each clinical visit	63.2% 24/38 • Number of events 24 • 1 year All adverse events were recorded during each clinical visit
Blood and lymphatic system disorders Anemia	65.0% 26/40 • Number of events 26 • 1 year All adverse events were recorded during each clinical visit	50.0% 19/38 • Number of events 19 • 1 year All adverse events were recorded during each clinical visit
Skin and subcutaneous tissue disorders Rash	12.5% 5/40 • Number of events 5 • 1 year All adverse events were recorded during each clinical visit	5.3% 2/38 • Number of events 2 • 1 year All adverse events were recorded during each clinical visit