Trial Outcomes & Findings for Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer (NCT NCT02318901)

Results Overview

PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

3 weeks

Results posted on

2019-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days. Pembrolizumab Trastuzumab	Arm 2 Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days. Pembrolizumab ado-trastuzumab emtansine	Arm 3 Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days. Pembrolizumab Cetuximab
Overall Study STARTED	5	1	10
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	5	1	10

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	Arm 1 n=5 Participants Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days. Pembrolizumab Trastuzumab	Arm 2 n=1 Participants Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days. Pembrolizumab ado-trastuzumab emtansine	Arm 3 n=10 Participants Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days. Pembrolizumab Cetuximab	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=1 Participants	0 Participants n=10 Participants	0 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	1 Participants n=1 Participants	10 Participants n=10 Participants	16 Participants n=16 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=1 Participants	0 Participants n=10 Participants	0 Participants n=16 Participants
Age, Continuous	52 years n=5 Participants	62 years n=1 Participants	58 years n=10 Participants	57 years n=16 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=1 Participants	10 Participants n=10 Participants	11 Participants n=16 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=1 Participants	0 Participants n=10 Participants	5 Participants n=16 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 Participants n=5 Participants	1 Participants n=1 Participants	10 Participants n=10 Participants	16 Participants n=16 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

Population: No data was analyzed for this trial. PI left site unexpectedly.

PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: No data was analyzed for this trial. PI left site unexpectedly.

PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

Population: No data was analyzed for this trial. PI left site unexpectedly.

PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

Population: No data was analyzed for this trial. PI left site unexpectedly.

PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: No data was analyzed for this trial. PI left site unexpectedly.

PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica L. Coats

WRMC

Phone: 623-207-3899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place