Trial Outcomes & Findings for A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection (NCT NCT04510285)

Last Updated: 2023-02-01

Results Overview

The primary endpoint of the study is the proportion of patients with ctDNA clearance at 6 months with trastuzumab/pembrolizumab or trastuzumab/placebo in patients with HER2+ esophagogastric cancer with persistent ctDNA despite curative surgery and standard perioperative/adjuvant therapy. CtDNA clearance is the conversion of detectable to undetectable ctDNA

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2023-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Trastuzumab and Pembrolizumab Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks. The planned dose of pembrolizumab for this study is 200 mg every 3 weeks. Trastuzumab: Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days). Pembrolizumab: Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Trastuzumab and Pembrolizumab Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks. The planned dose of pembrolizumab for this study is 200 mg every 3 weeks. Trastuzumab: Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days). Pembrolizumab: Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).
Overall Study Death	1

Baseline Characteristics

A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trastuzumab and Pembrolizumab n=1 Participants Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks. The planned dose of pembrolizumab for this study is 200 mg every 3 weeks. Trastuzumab: Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days). Pembrolizumab: Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).
Age, Continuous	86 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	1 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	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: N/A - data were not collected because the one participant accrued to the study died prematurely due to a treatment unrelated infection

Outcome measures

Outcome data not reported

Adverse Events

Trastuzumab and Pembrolizumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Trastuzumab and Pembrolizumab n=1 participants at risk Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks. The planned dose of pembrolizumab for this study is 200 mg every 3 weeks. Trastuzumab: Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days). Pembrolizumab: Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).
Infections and infestations Sepsis	100.0% 1/1 • 6 months
General disorders Death NOS	100.0% 1/1 • 6 months

Other adverse events

Other adverse events
Measure	Trastuzumab and Pembrolizumab n=1 participants at risk Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks. The planned dose of pembrolizumab for this study is 200 mg every 3 weeks. Trastuzumab: Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days). Pembrolizumab: Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • 6 months
General disorders Fatigue	100.0% 1/1 • 6 months
Gastrointestinal disorders Small intestinal obstruction	100.0% 1/1 • 6 months

Additional Information

Dr. Yelena Janjigian,MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place