Trial · NCT03239145
Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor
NCT03239145, Phase 1, Completed, Dana-Farber Cancer Institute; results first posted 2026-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor. Trials, record NCT03239145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03239145
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor
- NCT number
- NCT03239145
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 62 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Advanced Solid Tumor
- Interventions
- Pembrolizumab, Trebananib
- First posted
- 2017-08-03
- Last updated
- 2026-07-01
- Results first posted
- 2026-03-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experienced Dose Limit Toxicities (DLT) | 3 weeks | A standard 3+3 dose-escalation design was used during dose escalation period. DLT was defined in protocol section 5.5. |
| Primary | Maximum Tolerated Dose (MTD) of Trebananib | 3 weeks | MTD will be defined as the dose level at which fewer than one-third of participants experience a dose-limiting toxicity attributable to pembrolizumab and trebananib, as determined using a standard 3+3 dose-escalation design. |
| Primary | Grade 3 or Higher Toxicity Rate in Expansion Cohort | The median follow up time was 3.3 months (range: 0.6 to 25.3 months). | The percentage of participants who experienced grade 3 or higher adverse event based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4). |
| Secondary | Objective Response Rate (ORR) | Median follow-up was 29.3 months (range 0.9 - 42.0 months). | ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Progression Free Survival at 6 Months (PFS6) | 6 months | PFS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
| Secondary | Overall Survival at 1 Year (OS1) | 1 year | OS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. OS is defined as the time from or registration to death due to any cause, or censored at date last known alive. |
| Secondary | Median Time To Progression (TTP) | Median follow-up was 29.3 months (range 0.9 - 42.0 months). | TTP based on Kaplan-Meier method is defined as the time from registration to progression disease (PD), or censored at date of last disease evaluation for those without progression reported. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experienced Dose Limit Toxicities (DLT) | 3 weeks | DLTs will be monitored and collected for treated participants that enrolled during the dose escalation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Tolerated Dose (MTD) of Trebananib | 3 weeks | This analysis applies only to patients who were enrolled and treated during the dose-escalation period. | mg/kg | NUMBER |
| PRIMARY | Grade 3 or Higher Toxicity Rate in Expansion Cohort | The median follow up time was 3.3 months (range: 0.6 to 25.3 months). | This analysis only included participants enrolled and treated during the dose expansion period. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | Median follow-up was 29.3 months (range 0.9 - 42.0 months). | The analysis population will include patients enrolled in the dose escalation and dose expansion portions of the trial. Per protocol, the dose escalation and dose expansion data may be combined for patients with the same cancer type who received the same treatment doses. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival at 6 Months (PFS6) | 6 months | The analysis population will include patients enrolled in the dose escalation and dose expansion portions of the trial. Per protocol, the dose escalation and dose expansion data may be combined for patients with the same cancer type who received the same treatment doses. | percentage probability | NUMBER |
| SECONDARY | Overall Survival at 1 Year (OS1) | 1 year | The analysis population will include patients enrolled in the dose escalation and dose expansion portions of the trial. Per protocol, the dose escalation and dose expansion data may be combined for patients with the same cancer type who received the same treatment doses. | percentage of participants | NUMBER |
| SECONDARY | Median Time To Progression (TTP) | ian follow-up was 29.3 months (range 0.9 - 42.0 months). | The analysis population will include patients enrolled in the dose escalation and dose expansion portions of the trial. Per protocol, the dose escalation and dose expansion data may be combined for patients with the same cancer type who received the same treatment doses. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experienced Dose Limit Toxicities (DLT) | [Dose Escalation Dose Level I] Pembrolizumab + Trebananib | 0 | Participants | ||
| Number of Participants Experienced Dose Limit Toxicities (DLT) | [Dose Escalation Dose Level II] Pembrolizumab + Trebananib | 0 | Participants | ||
| Maximum Tolerated Dose (MTD) of Trebananib | [Dose Escalation Dose Level I and Dose Level II] Pembrolizumab + Trebananib | 30 | mg/kg | ||
| Grade 3 or Higher Toxicity Rate in Expansion Cohort | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 59.5 | 90% Confidence Interval 44.6 to 73.1 | percentage of participants | |
| Grade 3 or Higher Toxicity Rate in Expansion Cohort | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 63.6 | 90% Confidence Interval 35.0 to 86.5 | percentage of participants | |
| Grade 3 or Higher Toxicity Rate in Expansion Cohort | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 75.0 | 90% Confidence Interval 24.9 to 98.7 | percentage of participants | |
| Objective Response Rate (ORR) | [Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 7.5 | 90% Confidence Interval 2.1 to 18.3 | percentage of participants | |
| Objective Response Rate (ORR) | [Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 9.1 | 90% Confidence Interval 0.1 to 36.4 | percentage of participants | |
| Objective Response Rate (ORR) | [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 0 | 90% Confidence Interval 0 to 52.7 | percentage of participants | |
| Progression Free Survival at 6 Months (PFS6) | [Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 13 | 90% Confidence Interval 5 to 25 | percentage probability |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | [Dose Escalation Dose Level I] Pembrolizumab + Trebananib | 4 | |
| Overall Study | STARTED | [Dose Escalation Dose Level II] Pembrolizumab + Trebananib | 3 | |
| Overall Study | STARTED | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 39 | |
| Overall Study | STARTED | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 12 | |
| Overall Study | STARTED | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 4 | |
| Overall Study | Treated | [Dose Escalation Dose Level I] Pembrolizumab + Trebananib | 3 | |
| Overall Study | Treated | [Dose Escalation Dose Level II] Pembrolizumab + Trebananib | 3 | |
| Overall Study | Treated | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 37 | |
| Overall Study | Treated | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 11 | |
| Overall Study | Treated | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 4 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events764
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 | Anemia | Blood and lymphatic system disorders | [Dose Level I] Pembrolizumab + Trebananib | 2 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 21 | 40 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 5 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 4 | 4 | |
| other | Lymph node pain | Blood and lymphatic system disorders | [Dose Level I] Pembrolizumab + Trebananib | 0 | 3 | |
| other | Lymph node pain | Blood and lymphatic system disorders | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 2 | 40 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 0 | 11 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 0 | 4 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | [Dose Level I] Pembrolizumab + Trebananib | 0 | 3 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 1 | 40 |
1 to 10 of 764Source ClinicalTrials.gov
See all 764 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | [Dose Level I] Pembrolizumab + Trebananib | 2 | 3 |
| Total, all-cause mortality | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 22 | 40 |
| Total, all-cause mortality | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 5 | 11 |
| Total, all-cause mortality | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 4 | 4 |
| Total, other adverse events | [Dose Level I] Pembrolizumab + Trebananib | 3 | 3 |
| Total, other adverse events | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 40 | 40 |
| Total, other adverse events | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 11 | 11 |
| Total, other adverse events | Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 4 | 4 |
| Total, serious adverse events | [Dose Level I] Pembrolizumab + Trebananib | 2 | 3 |
| Total, serious adverse events | [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 14 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| [Dose Escalation Dose Level I] Pembrolizumab + Trebananib vs [Dose Escalation Dose Level II] Pembrolizumab + Trebananib: Number of Participants Experienced Dose Limit Toxicities (DLT) |
Source 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.
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Read this trial from software.
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