Trial Outcomes & Findings for Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma (NCT NCT02673333)

Last Updated: 2025-04-20

Results Overview

using RECIST v1.1 A Simon two stage minimax design will be employed to carry out this objective. In the first stage, 21 patients will be enrolled. If at least 3 out of 21 patients respond (partial response - PR or complete response - CR), we will enroll an additional 18 patients for a total of 39 patients. At the end of the study, 8 of 39 patients will need to respond to consider the therapy promising. The study will be complete when all subjects have either completed 24 months of drug therapy, progressed, or discontinued from the study for other reasons. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

2 years

Results posted on

2025-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W. Pembrolizumab
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=39 Participants Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W. Pembrolizumab
Age, Continuous	62 years n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	36 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	39 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Pembrolizumab n=39 Participants Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W. Pembrolizumab
Objective Response Rate (ORR) Complete Response	0 Participants
Objective Response Rate (ORR) Partial Response	9 Participants
Objective Response Rate (ORR) Stable Disease	7 Participants
Objective Response Rate (ORR) Progressive Disease	15 Participants
Objective Response Rate (ORR) Could Not Be Evaluated	8 Participants

Adverse Events

Pembrolizumab

Serious events: 5 serious events

Other events: 23 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=39 participants at risk Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W. Pembrolizumab
Investigations Increased AST/ALT	10.3% 4/39 • Up to 24 months
Metabolism and nutrition disorders Hypocalcemia	2.6% 1/39 • Up to 24 months
Metabolism and nutrition disorders Hypoalbuminemia	2.6% 1/39 • Up to 24 months
Metabolism and nutrition disorders Hypokalemia	2.6% 1/39 • Up to 24 months
Metabolism and nutrition disorders Hypophosphatemia	2.6% 1/39 • Up to 24 months
Metabolism and nutrition disorders Hypomagnesemia	2.6% 1/39 • Up to 24 months

Other adverse events

Other adverse events
Measure	Pembrolizumab n=39 participants at risk Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W. Pembrolizumab
Investigations Increased AST/ALT	23.1% 9/39 • Up to 24 months
Metabolism and nutrition disorders Hypocalcemia	10.3% 4/39 • Up to 24 months
Investigations Increased Alkaline Phosphatase	10.3% 4/39 • Up to 24 months
Investigations Lymphopenia	5.1% 2/39 • Up to 24 months
Metabolism and nutrition disorders Hypoalbuminemia	5.1% 2/39 • Up to 24 months
Investigations Increased Creatinine	5.1% 2/39 • Up to 24 months
General disorders Fatigue	20.5% 8/39 • Up to 24 months
General disorders Chills	5.1% 2/39 • Up to 24 months
Endocrine disorders Hypothyroidism	7.7% 3/39 • Up to 24 months
Gastrointestinal disorders Nausea	5.1% 2/39 • Up to 24 months
Skin and subcutaneous tissue disorders Pruritus	17.9% 7/39 • Up to 24 months
Skin and subcutaneous tissue disorders Rash	7.7% 3/39 • Up to 24 months
Skin and subcutaneous tissue disorders Hyperpigmentation	5.1% 2/39 • Up to 24 months
Skin and subcutaneous tissue disorders Dry Skin	5.1% 2/39 • Up to 24 months

Additional Information

Diane Reidy-Lagunes, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place