Trial · NCT02998268
Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma
NCT02998268, Phase 2, Active not recruiting, Weill Medical College of Cornell University; results first posted 2024-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma. Trials, record NCT02998268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02998268
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma
- NCT number
- NCT02998268
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Esophageal Adenocarcinoma
- Interventions
- Pembrolizumab, Taxol, Carboplatin
- First posted
- 2016-12-20
- Last updated
- 2026-03-17
- Results first posted
- 2024-05-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Major Pathological Response | Between approximately week 15 to 19 | Tumor tissue will be assessed for major pathological response as defined as complete response or near complete response. Pathologic response was assessed by tumor regression grade. This is a pathologic assessment of the amount of residual cancer cells in the specimen and the degree of fibrosis in the sample specimen. A completer response is 0% residual cancer cells. A partial response is 10-50% residual cancer cells, and no response is \>50% residual cancer cells within the tumor specimen. |
| Secondary | R0 Resection Rate. | 1 year | To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by R0 resection rate, which is reported as the number of participants achieving R0 resection. |
| Secondary | Overall Survival Rates | Until death from any cause or for a maximum of 5 years | To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by overall survival rates |
| Secondary | Number of Participants That Remained Progression Free as of 1 Year | 1 year | Number of participants that remained progression free (per RECIST v1.1) and alive as of 1 year |
| Other | Reduction of Local Immune Infiltration. | Up to 1 year post-surgery | To explore the effect of the combination of pembrolizumab with chemotherapy as assessed by the local immune infiltration in each treatment group. |
| Other | Prediction of Tumor Response. | Up to 1 year post-surgery | To examine whether anti PD1 therapy is associated with a transcriptomic signature of intra-tumoral immune activation predictive of response. |
| Other | Improved 1 Year Survival | 1 year | To examine whether anti PD1 therapy is associated with a transcriptomic signature of intra-tumoral immune activation predictive of improved 1 year survival. |
| Other | Induction of PD-L1 Expression or Induction of an Inflammatory Signature in Tumors. | Up to 1 year post-surgery. | To examine whether chemotherapy is associated with induction of PD-L1 expression or induction of an inflammatory signature in tumors |
| Other | Association of Anti-PD1 Therapy With Increased Intra-tumoral Immune Cell Infiltration. | Up to 1 year post-surgery. | To examine whether anti PD1 therapy is associated with increased intra-tumoral immune cell infiltration. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Major Pathological Response | Between approximately week 15 to 19 | 3 participants in Cohort 2 did not have surgery and were therefore ineligible. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | R0 Resection Rate. | 1 year | 1 participant in Cohort 1 and 3 participants in Cohort 2 were unevaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival Rates | Until death from any cause or for a maximum of 5 years | |||
| SECONDARY | Number of Participants That Remained Progression Free as of 1 Year | 1 year | 3 participants in Cohort 2 were unevaluable | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Reduction of Local Immune Infiltration. | Up to 1 year post-surgery | |||
| OTHER_PRE_SPECIFIED | Prediction of Tumor Response. | Up to 1 year post-surgery | |||
| OTHER_PRE_SPECIFIED | Improved 1 Year Survival | 1 year | |||
| OTHER_PRE_SPECIFIED | Induction of PD-L1 Expression or Induction of an Inflammatory Signature in Tumors. | Up to 1 year post-surgery. | |||
| OTHER_PRE_SPECIFIED | Association of Anti-PD1 Therapy With Increased Intra-tumoral Immune Cell Infiltration. | Up to 1 year post-surgery. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Major Pathological Response | Cohort 1 | 9 | Participants | ||
| Number of Participants With Major Pathological Response | Cohort 2 | 10 | Participants | ||
| R0 Resection Rate. | Cohort 1 | 17 | Participants | ||
| R0 Resection Rate. | Cohort 2 | 16 | Participants | ||
| Number of Participants That Remained Progression Free as of 1 Year | Cohort 1 | 15 | Participants | ||
| Number of Participants That Remained Progression Free as of 1 Year | Cohort 2 | 12 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 20 | |
| Overall Study | STARTED | Cohort 2 | 22 | |
| Overall Study | COMPLETED | Cohort 1 | 20 | |
| Overall Study | COMPLETED | Cohort 2 | 19 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 3 |
Source ClinicalTrials.gov
Adverse events240
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Cohort 1 | 4 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 2 | 0 | 22 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 | 16 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 | 7 | 22 | |
| other | Alanine Aminotransferase Increased | Investigations | Cohort 1 | 5 | 20 | |
| other | Alanine Aminotransferase Increased | Investigations | Cohort 2 | 3 | 22 | |
| other | Alkaline Phosphatase Increased | Investigations | Cohort 1 | 3 | 20 | |
| other | Alkaline Phosphatase Increased | Investigations | Cohort 2 | 2 | 22 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort 1 | 14 | 20 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort 2 | 13 | 22 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 7 | 20 |
| Total, all-cause mortality | Cohort 2 | 9 | 22 |
| Total, other adverse events | Cohort 1 | 20 | 20 |
| Total, other adverse events | Cohort 2 | 22 | 22 |
| Total, serious adverse events | Cohort 1 | 8 | 20 |
| Total, serious adverse events | Cohort 2 | 13 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: Number of Participants With Major Pathological Response | Trial comparisons |
| Cohort 1 vs Cohort 2: R0 Resection Rate. | Trial comparisons |
| Cohort 1 vs Cohort 2: Number of Participants That Remained Progression Free as of 1 Year | Trial comparisons |
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02998268
GET https://conductscience.org/api/trials/v1/NCT02998268/events?page=2