Trial Outcomes & Findings for Pembrolizumab Plus Docetaxel for the Treatment of Recurrent or Metastatic Head and Neck Cancer (NCT NCT02718820)

NCT ID: NCT02718820

Last Updated: 2024-01-09

Results Overview

Overall response rate will be measured

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-01-09

Participant Flow

Participant milestones

Measure	Docetaxel Plus Pembrolizumab Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab Plus Docetaxel for the Treatment of Recurrent or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Measure	Docetaxel Plus Pembrolizumab n=22 Participants Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Age, Customized	62.5 years n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	22 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Austria	22 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Overall response rate will be measured

Outcome measures

Measure	Docetaxel Plus Pembrolizumab n=22 Participants Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Overall Response Rate	22.7 percentage Interval 10.1 to 43.3

SECONDARY outcome

Timeframe: 4 years

Kaplan meier curves will be calculated and OS in months measured

Outcome measures

Measure	Docetaxel Plus Pembrolizumab n=22 Participants Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Median Overall Survival (OS)	21.3 months Interval 6.3 to 31.3

SECONDARY outcome

Timeframe: 4 years

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Outcome measures

Measure	Docetaxel Plus Pembrolizumab n=22 Participants Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Treatment-related Adverse Events	22 Count of Participants

SECONDARY outcome

Timeframe: 4 years

Kaplan meier curves will be calculated and PFS in months measured

Outcome measures

Measure	Docetaxel Plus Pembrolizumab n=22 Participants Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Median Progression Free Survival (PFS)	5.8 months Interval 2.7 to 11.6

Adverse Events

Docetaxel Plus Pembrolizumab

Serious events: 12 serious events

Other events: 22 other events

Deaths: 17 deaths

Serious adverse events

Measure	Docetaxel Plus Pembrolizumab n=22 participants at risk Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Blood and lymphatic system disorders Thrombocytopenia	4.5% 1/22 • 5 years
Blood and lymphatic system disorders Febrile Neutropenia	4.5% 1/22 • 5 years
General disorders Decreased General Condition	18.2% 4/22 • 5 years
Gastrointestinal disorders Nausea	4.5% 1/22 • 5 years
Gastrointestinal disorders Oral hemorrhage	22.7% 5/22 • 5 years
Infections and infestations Lung Infection	4.5% 1/22 • 5 years

Other adverse events

Measure	Docetaxel Plus Pembrolizumab n=22 participants at risk Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21
Blood and lymphatic system disorders Febrile Neutropenia	13.6% 3/22 • 5 years
Blood and lymphatic system disorders Anemia	40.9% 9/22 • 5 years
Blood and lymphatic system disorders Neutropenia	68.2% 15/22 • 5 years
Gastrointestinal disorders Nausea	13.6% 3/22 • 5 years
Gastrointestinal disorders Dysphagia	4.5% 1/22 • 5 years
Gastrointestinal disorders Oral hemorrhage	13.6% 3/22 • 5 years
Gastrointestinal disorders Gastric hemorrhage	13.6% 3/22 • 5 years
Metabolism and nutrition disorders Dehydration	9.1% 2/22 • 5 years
Metabolism and nutrition disorders Hypophosphatemia	4.5% 1/22 • 5 years
Investigations Creatinine increased	4.5% 1/22 • 5 years
Investigations GGT increased	9.1% 2/22 • 5 years
Nervous system disorders Syncope	9.1% 2/22 • 5 years
Infections and infestations Lung infection	4.5% 1/22 • 5 years
Infections and infestations Sepsis	4.5% 1/22 • 5 years
Infections and infestations Wound infection	4.5% 1/22 • 5 years

Additional Information

Thorsten Fuereder

Medical University of Vienna

Phone: +43140400

Email: thorsten.fuereder@meduniwien.ac.at

Results disclosure agreements

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