Trial · NCT02720484

Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer

NCT02720484, Phase 2, Terminated, Northwestern University; results first posted 2019-05-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer. Trials, record NCT02720484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720484

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer
NCT number: NCT02720484
Status: Terminated
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Northwestern University
Conditions: Metastatic Carcinoma in the Adrenal Cortex, Recurrent Adrenal Cortex Carcinoma, Stage III Adrenal Cortex Carcinoma, Stage IV Adrenal Cortex Carcinoma
Interventions: Laboratory Biomarker Analysis, Nivolumab
First posted: 2016-03-28
Last updated: 2019-05-01
Results first posted: 2019-05-01
Limitations and caveats: The study did not meet its first stage requirements of Interim analysis.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate	From the start of treatment and every 8 weeks/2 cycles with a range of cycles attempted 1-15.	Overall Response Rate of nivolumab treatment for patients with metastatic adrenocortical carcinoma will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI scans every 8 weeks: Complete Response (CR) = disappearance of all target lesions. Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions (should be confirmed 8 weeks after initial response otherwise considered unconfirmed PR). Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions..
Secondary	Progression-free Survival (PFS)	From start of treatment and every 8 weeks/2 cycles until progressive disease or death. Median follow up of 4.5 months	Progression Free Survival (PFS) of nivolumab treatment in patients with metastatic adrenocortical carcinoma is defined as the duration of time from start of treatment to time of documented progression or death, whichever comes first. It will measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI scans every 8 weeks.
Secondary	Overall Survival (OS) at 3 Months and 6 Months	At 3 months and 6 months from the initiation of treatment	Overall Survival (OS) of nivolumab treatment in patients with metastatic adrenocortical carcinoma and will be defined as the duration of time from treatment initiation until death. OS will be assessed as the percentage of patients alive at 3 months and at 6 months from initiation of treatment on study.
Secondary	Toxicity of Nivolumab	From treatment initiation, twice every Cycle (every 14 days) while on treatment, up to 12 weeks after final dose. Range of cycles completed 1-15 (1 Cycle=28 days)	Safety and tolerability profile of Nivolumab will be assessed by describing by number, frequency, and severity of Adverse Events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3. All AEs that were considered related to Nivolumab were collected and are shown below. Patients with multiple events in the same category are counted only once in that category. Patients with events in more than one category are counted in each of those categories. Categories with no events are not shown. In general AEs will be graded according to the following: Grade 1 = Mild AE Grade 2= Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE
Other	Levels of Cytokines	At baseline and at 4 weeks of treatment	Humoral and cellular responses to tumor antigens on serum samples will be evaluated by measuring the levels of cytokines (ie, IL-2, IL-6, IL-8, IL-10, IL-18, IFN gamma and TNF-alpha). Potential correlations between differential measures of response and the toxicity and efficacy of nivolumab will be explored.
Other	Levels of Peripheral Blood Lymphocyte Phenotype	At baseline and at 4 weeks of treatment	Humoral and cellular responses to tumor antigens on serum samples will be evaluated by measuring the levels of peripheral blood lymphocyte phenotype. Potential correlations between differential measures of response and the toxicity and efficacy of nivolumab will be explored.
Other	PD-L1 Expression	At baseline and at 4 weeks of treatment	PD-L1 expression will assist in assessing Overall response rate, PFS, and OS for this treatment.
Other	PD-L2 Expression	At baseline and at 4 weeks of treatment	PD-L2 expression will assist in assessing Overall response rate, PFS, and OS for this treatment.
Other	Peripheral T Cell Profile Levels	At baseline and at 4 weeks of treatment	Peripheral T cell profile levels will assist in assessing Overall response rate, PFS, and OS for this treatment.
Other	Serum Interleukin Levels	At baseline and at 4 weeks of treatment	Serum interleukin levels will assist in assessing Overall response rate, PFS, and OS for this treatment.

Source ClinicalTrials.gov

Outcomes11

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 the start of treatment and every 8 weeks/2 cycles with a range of cycles attempted 1-15.	All patients that received one dose of nivolumab were evaluable for this objective.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival (PFS)	From start of treatment and every 8 weeks/2 cycles until progressive disease or death. Median follow up of 4.5 months		Months	MEDIAN
SECONDARY	Overall Survival (OS) at 3 Months and 6 Months	At 3 months and 6 months from the initiation of treatment		percentage of patients alive	NUMBER
SECONDARY	Toxicity of Nivolumab	From treatment initiation, twice every Cycle (every 14 days) while on treatment, up to 12 weeks after final dose. Range of cycles completed 1-15 (1 Cycle=28 days)		participants	NUMBER
OTHER_PRE_SPECIFIED	Levels of Cytokines	At baseline and at 4 weeks of treatment
OTHER_PRE_SPECIFIED	Levels of Peripheral Blood Lymphocyte Phenotype	At baseline and at 4 weeks of treatment
OTHER_PRE_SPECIFIED	PD-L1 Expression	At baseline and at 4 weeks of treatment
OTHER_PRE_SPECIFIED	PD-L2 Expression	At baseline and at 4 weeks of treatment
OTHER_PRE_SPECIFIED	Peripheral T Cell Profile Levels	At baseline and at 4 weeks of treatment
OTHER_PRE_SPECIFIED	Serum Interleukin Levels	At baseline and at 4 weeks of treatment

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate	Treatment (Nivolumab)	Complete Response	0		Participants
Overall Response Rate	Treatment (Nivolumab)	Unconfirmed Partial Response	1		Participants
Overall Response Rate	Treatment (Nivolumab)	Stable Disease	2		Participants
Overall Response Rate	Treatment (Nivolumab)	Progressive Disease	6		Participants
Overall Response Rate	Treatment (Nivolumab)	NE	1		Participants
Progression-free Survival (PFS)	Treatment (Nivolumab)		1.8	95% Confidence Interval 0.1 to 4.3	Months
Overall Survival (OS) at 3 Months and 6 Months	Treatment (Nivolumab)	3 months	79	95% Confidence Interval 14 to 90	percentage of patients alive
Overall Survival (OS) at 3 Months and 6 Months	Treatment (Nivolumab)	6 months	56	95% Confidence Interval 8 to 88	percentage of patients alive
Toxicity of Nivolumab	Treatment (Nivolumab)	Rash Grade 1-2	3		participants
Toxicity of Nivolumab	Treatment (Nivolumab)	Nausea Grade 1-2	1		participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment on Study	STARTED	Treatment (Nivolumab)	10
Treatment on Study	Reached 1st Response/2 Cycles	Treatment (Nivolumab)	7
Treatment on Study	Treated Cycle 3	Treatment (Nivolumab)	4
Treatment on Study	COMPLETED	Treatment (Nivolumab)	4
Treatment on Study	NOT COMPLETED	Treatment (Nivolumab)	6
Follow Up for 2 Years	STARTED	Treatment (Nivolumab)	7
Follow Up for 2 Years	COMPLETED	Treatment (Nivolumab)	1
Follow Up for 2 Years	NOT COMPLETED	Treatment (Nivolumab)	6

Source ClinicalTrials.gov

Adverse events83

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
other	Anemia	Blood and lymphatic system disorders	Treatment (Nivolumab)	5	10
other	Atrial Flutter	Cardiac disorders	Treatment (Nivolumab)	1	10
other	Sinus Tachycardia	Cardiac disorders	Treatment (Nivolumab)	2	10
other	Adrenal Insufficiency	Endocrine disorders	Treatment (Nivolumab)	1	10
other	Hypothyroidism	Endocrine disorders	Treatment (Nivolumab)	1	10
other	Blurred Vision	Eye disorders	Treatment (Nivolumab)	1	10
other	Abdominal Pain	Gastrointestinal disorders	Treatment (Nivolumab)	3	10
other	Ascites	Gastrointestinal disorders	Treatment (Nivolumab)	1	10
other	Constipation	Gastrointestinal disorders	Treatment (Nivolumab)	1	10
other	Diarrhea	Gastrointestinal disorders	Treatment (Nivolumab)	1	10

1 to 10 of 83Source ClinicalTrials.gov

See all 83 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Nivolumab)	5	10
Total, other adverse events	Treatment (Nivolumab)	10	10
Total, serious adverse events	Treatment (Nivolumab)	7	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31276163	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA060553	The Robert H. Lurie Comprehensive Cancer Center	PLATANIAS, LEONIDAS C.	NORTHWESTERN UNIVERSITY	NATIONAL CANCER INSTITUTE	1993 to 2025

Source NIH RePORTER

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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02720484

GET https://conductscience.org/api/trials/v1/NCT02720484/results?page=2

API reference For AI assistants