Trial · NCT04099641
An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
NCT04099641, Phase 2, Completed, OncXerna Theraputics, Inc.; results first posted 2023-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients. Trials, record NCT04099641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04099641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
- NCT number
- NCT04099641
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- OncXerna Theraputics, Inc.
- Conditions
- Gastric Cancer, GastroEsophageal Cancer
- Interventions
- Bavituximab, Pembrolizumab Injection
- First posted
- 2019-09-23
- Last updated
- 2023-02-08
- Other registries' IDs
- eudract:2019-000949-13
- Results first posted
- 2023-02-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Treatment Emergent Adverse Events (TEAE) | From first dose through 30 days after last dose. Maximum exposure: 567 days. | Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose. |
| Primary | Severity of Treatment Emergent Adverse Events (TEAE) | From first dose through 30 days after last dose. Maximum exposure: 567 days. | Severity of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose. |
| Primary | Objective Response Rate (ORR) | From date of first dose until the date of CR, PR, first documented progression or date of death from any cause, whichever came first. Maximum exposure: 567 days. | ORR was based on RECIST version 1.1 criteria for target lesions, where a patient may achieve as best overall response (BOR) either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline summary of diameters. ORR is calculated as the number of patients achieving a CR or PR (objective response) divided by the number of efficacy patients. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Treatment Emergent Adverse Events (TEAE) | From first dose through 30 days after last dose. Maximum exposure: 567 days. | Analysis was performed on the safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Severity of Treatment Emergent Adverse Events (TEAE) | From first dose through 30 days after last dose. Maximum exposure: 567 days. | Analysis was performed on the safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) | From date of first dose until the date of CR, PR, first documented progression or date of death from any cause, whichever came first. Maximum exposure: 567 days. | The efficacy population include all participants enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events (TEAE) | Group 1 (CPI Naïve) | 61 | Participants | ||
| Number of Patients With Treatment Emergent Adverse Events (TEAE) | Group 2 (CPI Relapse) | 19 | Participants | ||
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 1 (CPI Naïve) | At least one Grade 1 TEAE | 3 | Participants | |
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 2 (CPI Relapse) | At least one Grade 1 TEAE | 4 | Participants | |
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 1 (CPI Naïve) | At least one Grade 2 TEAE | 19 | Participants | |
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 2 (CPI Relapse) | At least one Grade 2 TEAE | 2 | Participants | |
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 1 (CPI Naïve) | At least one Grade 3 TEAE | 21 | Participants | |
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 2 (CPI Relapse) | At least one Grade 3 TEAE | 8 | Participants | |
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 1 (CPI Naïve) | At least one Grade 4 TEAE | 1 | Participants | |
| Severity of Treatment Emergent Adverse Events (TEAE) | Group 2 (CPI Relapse) | At least one Grade 4 TEAE | 0 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (CPI Naïve) | 61 | |
| Overall Study | STARTED | Group 2 (CPI Relapse) | 19 | |
| Overall Study | Safety Population | Group 1 (CPI Naïve) | 61 | |
| Overall Study | Safety Population | Group 2 (CPI Relapse) | 19 | |
| Overall Study | DLT-evaluable Population | Group 1 (CPI Naïve) | 3 | |
| Overall Study | DLT-evaluable Population | Group 2 (CPI Relapse) | 0 | |
| Overall Study | Efficacy Population | Group 1 (CPI Naïve) | 61 | |
| Overall Study | Efficacy Population | Group 2 (CPI Relapse) | 19 | |
| Overall Study | COMPLETED | Group 1 (CPI Naïve) | 12 | |
| Overall Study | COMPLETED | Group 2 (CPI Relapse) | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events264
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 | Anaemia | Blood and lymphatic system disorders | Group 1 (CPI Naïve) | 14 | 61 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 2 (CPI Relapse) | 3 | 19 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Group 1 (CPI Naïve) | 0 | 61 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Group 2 (CPI Relapse) | 1 | 19 | |
| other | Hypothyroidism | Endocrine disorders | Group 1 (CPI Naïve) | 7 | 61 | |
| other | Hypothyroidism | Endocrine disorders | Group 2 (CPI Relapse) | 0 | 19 | |
| other | Constipation | Gastrointestinal disorders | Group 1 (CPI Naïve) | 16 | 61 | |
| other | Constipation | Gastrointestinal disorders | Group 2 (CPI Relapse) | 9 | 19 | |
| other | Nausea | Gastrointestinal disorders | Group 1 (CPI Naïve) | 18 | 61 | |
| other | Nausea | Gastrointestinal disorders | Group 2 (CPI Relapse) | 5 | 19 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (CPI Naïve) | 46 | 61 |
| Total, all-cause mortality | Group 2 (CPI Relapse) | 12 | 19 |
| Total, other adverse events | Group 1 (CPI Naïve) | 61 | 61 |
| Total, other adverse events | Group 2 (CPI Relapse) | 19 | 19 |
| Total, serious adverse events | Group 1 (CPI Naïve) | 29 | 61 |
| Total, serious adverse events | Group 2 (CPI Relapse) | 10 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42346219 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 (CPI Naïve) vs Group 2 (CPI Relapse): deaths from any cause | Trial comparisons |
| Group 1 (CPI Naïve) vs Group 2 (CPI Relapse): Number of Patients With Treatment Emergent Adverse Events (TEAE) | Trial comparisons |
| Group 1 (CPI Naïve) vs Group 2 (CPI Relapse): 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/NCT04099641
GET https://conductscience.org/api/trials/v1/NCT04099641/results?page=2