Trial Outcomes & Findings for Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma (NCT NCT04089904)

Results Overview

Determine the pCR rate in patients with gastroesophageal adenocarcinoma (GEA) treated with neoadjuvant pembrolizumab followed by surgery. Regression of the primary tumor will be documented by the amount of viable tumor verses the amount of fibrosis using Becker Criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

11 weeks

Results posted on

2024-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	ARM 1 Pembrolizumab Injection: Patients will receive 3 cycles of pembrolizumab at 200mg intravenously on day 1 of a 3 week cycle. After 3 cycles the patients will undergo surgery
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM 1 n=3 Participants Pembrolizumab Injection: Patients will receive 3 cycles of pembrolizumab at 200mg intravenously on day 1 of a 3 week cycle. After 3 cycles the patients will undergo surgery
Age, Continuous	46.3 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 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	1 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	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: The study was terminated due to low accrual. Data for this outcome was not collected.

Determine the pCR rate in patients with gastroesophageal adenocarcinoma (GEA) treated with neoadjuvant pembrolizumab followed by surgery. Regression of the primary tumor will be documented by the amount of viable tumor verses the amount of fibrosis using Becker Criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

Population: The study was terminated due to low accrual. Data for this outcome was not collected.

GEA patients treated with neoadjuvant pembrolizumab using proximal, distal and circumferential margins to determine the completeness of resection. The absence of tumor cells at the proximal and distal margins will be required to be classified as an R0 resection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

Population: The study was terminated due to low accrual. Data for this outcome was not collected.

To determine rates of grade 1a (complete), 1b(minimal residual disease), 2 (partial response) and 3 (no response)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

Evaluate the safety/tolerability patient response of pembrolizumab in patients with GEA. Number of patients with GEA taking pembrolizumab with treatment-related adverse events as assessed by CTCAE.

Outcome measures

Outcome measures
Measure	ARM 1 n=3 Participants Pembrolizumab Injection: Patients will receive 3 cycles of pembrolizumab at 200mg intravenously on day 1 of a 3 week cycle. After 3 cycles the patients will undergo surgery
Number of Patients With GEA Taking Pembrolizumab With Treatment-related Adverse Events	1 Participants

SECONDARY outcome

Timeframe: 11 weeks

Population: The study was terminated due to low accrual. Data for this outcome was not collected.

DFS rate measured from the time of the first pembrolizumab dose to disease recurrence or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

Population: The study was terminated due to low accrual. Data for this outcome was not collected.

Overall survival rate of patients measured from the time of first pembrolizumab dose to death.

Outcome measures

Outcome data not reported

Adverse Events

ARM 1

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ARM 1 n=3 participants at risk Pembrolizumab Injection: Patients will receive 3 cycles of pembrolizumab at 200mg intravenously on day 1 of a 3 week cycle. After 3 cycles the patients will undergo surgery
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Up to 1 year
Surgical and medical procedures Surgical	33.3% 1/3 • Up to 1 year

Other adverse events

Adverse event data not reported

Additional Information

Theodore Karrison (Research Professor)

University of Chicago

Phone: 7737029326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place