Trial · NCT05634577
A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma
NCT05634577, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma. Trials, record NCT05634577. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05634577
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma
- NCT number
- NCT05634577
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Adrenocortical Carcinoma
- Interventions
- Mitotane, Pembrolizumab
- First posted
- 2022-12-02
- Last updated
- 2025-06-19
- Results first posted
- 2025-06-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | From time of active itervention (Combination therapy) | Assessment of tumor reduction by RECIST1.1 criteria |
| Secondary | Overall Survival | Overall survival (OS), defined as the time from combination therapy to death from any cause. | |
| Secondary | Progression Free Survival | Progression Free Survival (PFS), defined as the time from the start of combination therapy phase to disease progression or death from any cause. | |
| Secondary | Side Effects and Relationship Between Response and Drug Level | Explore the association between MT level and response to therapy Safety assessment by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 |
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 | Overall Response Rate | From time of active itervention (Combination therapy) | Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points. | ||
| SECONDARY | Overall Survival | Overall survival (OS), defined as the time from combination therapy to death from any cause. | Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points. | ||
| SECONDARY | Progression Free Survival | Progression Free Survival (PFS), defined as the time from the start of combination therapy phase to disease progression or death from any cause. | Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points. | ||
| SECONDARY | Side Effects and Relationship Between Response and Drug Level | Explore the association between MT level and response to therapy Safety assessment by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 | Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Pembrolizumab With Mitotane | 3 | |
| Overall Study | COMPLETED | Combination Pembrolizumab With Mitotane | 1 | |
| Overall Study | NOT COMPLETED | Combination Pembrolizumab With Mitotane | 2 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Nausea | Gastrointestinal disorders | Combination Pembrolizumab With Mitotane | 1 | 3 | |
| serious | Fever | General disorders | Combination Pembrolizumab With Mitotane | 1 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Pembrolizumab With Mitotane | 0 | 3 |
| Total, other adverse events | Combination Pembrolizumab With Mitotane | 0 | 3 |
| Total, serious adverse events | Combination Pembrolizumab With Mitotane | 1 | 3 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05634577
GET https://conductscience.org/api/trials/v1/NCT05634577/registered