Trial Outcomes & Findings for A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma (NCT NCT05634577)

NCT ID: NCT05634577

Last Updated: 2025-06-19

Results Overview

Assessment of tumor reduction by RECIST1.1 criteria

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

From time of active itervention (Combination therapy)

Results posted on

2025-06-19

Participant Flow

3 patients consented and one withdrew consent prior to immunotherapy (the key study intervention)

Participant milestones

Participant milestones
Measure	Combination Pembrolizumab With Mitotane Active intervention
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Pembrolizumab With Mitotane Active intervention
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Pembrolizumab With Mitotane n=3 Participants Active intervention
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants

PRIMARY outcome

Timeframe: From time of active itervention (Combination therapy)

Population: Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points.

Assessment of tumor reduction by RECIST1.1 criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Overall survival (OS), defined as the time from combination therapy to death from any cause.

Population: Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Progression Free Survival (PFS), defined as the time from the start of combination therapy phase to disease progression or death from any cause.

Population: Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Explore the association between MT level and response to therapy Safety assessment by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Population: Data were not collected for any participant due to study termination prior to participants' assessment at the pre-specified time points.

Outcome measures

Outcome data not reported

Adverse Events

Combination Pembrolizumab With Mitotane

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Pembrolizumab With Mitotane n=3 participants at risk Active intervention
Gastrointestinal disorders Nausea	33.3% 1/3 • Approximately 1 year and 3 months Three particpants assessed for Adverse events
General disorders Fever	33.3% 1/3 • Approximately 1 year and 3 months Three particpants assessed for Adverse events

Other adverse events

Adverse event data not reported

Additional Information

Mouhammed Habra, MD

M D Anderson Cancer Center

Phone: 713-792-2841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place