Trial · NCT02689219
Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
NCT02689219, Phase 2, Terminated, Nabil Adra; results first posted 2019-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors. Trials, record NCT02689219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02689219
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
- NCT number
- NCT02689219
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Nabil Adra
- Conditions
- Germ Cell Tumors, Testis Cancer, Testicular Cancer, Embryonal Carcinoma, Nonseminomatous Germ Cell Tumor
- Interventions
- Brentuximab Vedotin
- First posted
- 2016-02-23
- Last updated
- 2019-12-10
- Results first posted
- 2019-11-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (Percent of Patients With Complete Response or Partial Response) | Up to 1 year | Measured by RECIST v1.1 and tumor markers (AFP and BhCG). CR - disappearance of all target lesions and normalization of serum tumor markers for at least 4 weeks. When only evidence of disease is elevated serum tumor markers, then values must fall below the upper limit of normal for the assay and remain at that level for at least 4 weeks. PR - at least a 30% decrease in the sum of the diameters of target lesions compared to the baseline sum diameters for at least 2 measurements 1 month apart with the serum markers as stable/decreasing. When only evidence of disease is elevated serum tumor markers, then values must fall \>=90% below baseline pretreatment levels for BhCG or 50% decrease below baseline pretreatment levels for AFP and persist for 6 weeks. If both tumor markers are elevated and one falls below 90% the other should fall at least below 50% of baseline pretreatment levels.The percent of patients with objective response and its 95% exact confidence interval will be provided. |
| Secondary | Progression Free Survival | Up to 2 years | Duration of time from the start of treatment to time of documented progression or death. Patients who did not progress or die were censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated. |
| Secondary | Overall Survival | Up to 2 years | Duration of time from the start of treatment to time of death due to any causes. Patients who did not die were censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated. |
| Secondary | Number of Patients With Treatment Related Adverse Events Grade 3 or Above | Up to 2 years | Number of unique patients who had a treatment related (possible, probable or definite) adverse event with grade \>= 3 using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (Percent of Patients With Complete Response or Partial Response) | Up to 1 year | All patients who received at least one dose of study medication and at least one evaluable assessment after treatment. | percentage of patients | NUMBER |
| SECONDARY | Progression Free Survival | Up to 2 years | All patients who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Overall Survival | Up to 2 years | All patients who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Number of Patients With Treatment Related Adverse Events Grade 3 or Above | Up to 2 years | All patients who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (Percent of Patients With Complete Response or Partial Response) | CD30 Negative/Unknown | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| Objective Response (Percent of Patients With Complete Response or Partial Response) | CD30 Positive | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| Progression Free Survival | CD30 Negative/Unknown | 1.38 | 95% Confidence Interval 0.00 to 2.07 | months | |
| Progression Free Survival | CD30 Positive | 1.15 | 95% Confidence Interval 0.92 to 2.11 | months | |
| Overall Survival | CD30 Negative/Unknown | 5.89 | 95% Confidence Interval 1.64 to 8.19 | months | |
| Overall Survival | CD30 Positive | 2.53 | 95% Confidence Interval 1.12 to 12.89 | months | |
| Number of Patients With Treatment Related Adverse Events Grade 3 or Above | CD30 Negative/Unknown | 0 | Participants | ||
| Number of Patients With Treatment Related Adverse Events Grade 3 or Above | CD30 Positive | 2 | 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 | CD30 Negative/Unknown | 11 | |
| Overall Study | STARTED | CD30 Positive | 7 | |
| Overall Study | COMPLETED | CD30 Negative/Unknown | 0 | |
| Overall Study | COMPLETED | CD30 Positive | 0 | |
| Overall Study | NOT COMPLETED | CD30 Negative/Unknown | 11 | |
| Overall Study | NOT COMPLETED | CD30 Positive | 7 |
Source ClinicalTrials.gov
Adverse events122
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 | CD30 Negative/Unknown | 2 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | CD30 Positive | 1 | 7 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | CD30 Negative/Unknown | 1 | 11 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | CD30 Positive | 0 | 7 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CD30 Negative/Unknown | 1 | 11 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CD30 Positive | 0 | 7 | |
| other | Supraventricular tachycardia | Cardiac disorders | CD30 Negative/Unknown | 0 | 11 | |
| other | Supraventricular tachycardia | Cardiac disorders | CD30 Positive | 1 | 7 | |
| other | Hearing impaired | Ear and labyrinth disorders | CD30 Negative/Unknown | 2 | 11 | |
| other | Hearing impaired | Ear and labyrinth disorders | CD30 Positive | 0 | 7 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CD30 Negative/Unknown | 8 | 11 |
| Total, all-cause mortality | CD30 Positive | 6 | 7 |
| Total, other adverse events | CD30 Negative/Unknown | 11 | 11 |
| Total, other adverse events | CD30 Positive | 7 | 7 |
| Total, serious adverse events | CD30 Negative/Unknown | 2 | 11 |
| Total, serious adverse events | CD30 Positive | 3 | 7 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CD30 Negative/Unknown vs CD30 Positive: Number of Patients With Treatment Related Adverse Events Grade 3 or Above | Trial comparisons |
| CD30 Negative/Unknown vs CD30 Positive: deaths from any cause | Trial comparisons |
| CD30 Negative/Unknown vs CD30 Positive: 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/NCT02689219
GET https://conductscience.org/api/trials/v1/NCT02689219/events?page=2