Actively Recruiting
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
48
Participants Needed
65
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer.
CONDITIONS
Official Title
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed adrenocortical carcinoma by histology or cytology
- Disease must be locally advanced unresectable or recurrent/metastatic
- Disease must be measurable by RECIST version 1.1 criteria
- Up to 3 prior systemic therapy lines allowed; treatment-nafve patients are eligible
- Mitotane treatment must be stopped 28 days before registration and levels below 2 mg/L if given within 6 months
- No prior treatment with cabozantinib, cMET inhibitors, or anti-CTLA-4/PD-1/PD-L1 therapies
- Previous radiation, chemotherapy, or targeted therapies allowed if stopped at least 14 days before registration and toxicities resolved to grade 1 or less (except alopecia or mild neuropathy)
- Clinically adequate wound healing from prior therapies before enrollment
- Age 12 years or older with body surface area 21.2 m
- ECOG performance status 0-2 for adults; Lansky score 21 50 for ages 12 to <16; Karnofsky score 21 50 for ages 16 to <18
- Neutrophil count 1,000/mcL without growth factor support within 2 weeks
- Platelets 100,000/mcL
- Hemoglobin 8 g/dL
- Total bilirubin 1.5 x upper limit of normal (ULN), or 3 mg/dL if Gilbert's disease
- AST/ALT 3 x ULN
- Urine protein creatinine ratio 1 mg/mg
- Creatinine clearance 30 mL/min
- Assessment of adrenal steroid production within 3 months prior to registration
- Negative pregnancy test for women of childbearing potential within 14 days
- Cardiac function class II or better by NYHA within 28 days
- No congenital long QT syndrome or myocarditis
- No myocardial infarction or unstable angina within 6 months
- No significant gastrointestinal conditions increasing bleeding or perforation risk
- No pancreatitis or recent fractures within specified timeframes
- No uncontrolled hypertension within 14 days
- No major blood vessel tumor invasion or recent pulmonary hemorrhage
- No history of pneumonitis
- No brain metastases unless treated and stable for at least 4 weeks
- No recent major or minor surgery with ongoing complications
- Ability to swallow oral tablets
- No allergic reaction to cabozantinib or similar compounds
- Prior or concurrent malignancies allowed if not interfering with study
- HIV patients on effective therapy with undetectable viral load
- Controlled hepatitis B and C infections
- No active autoimmune disease requiring immune suppressive treatment
- No steroid use above 10 mg prednisone equivalents daily
- No strong CYP3A4 inhibitors or inducers within 14 days
- No herbal or traditional Chinese medicines
- Restrictions on use of certain anticoagulants
- For crossover: documented disease progression on cabozantinib monotherapy
You will not qualify if you...
- Pregnant or nursing individuals
- Patients with history of myocarditis or congenital long QT syndrome
- History of myocardial infarction or unstable angina within the past 6 months
- Clinically significant gastrointestinal abnormalities that increase bleeding or perforation risk
- History of gastrointestinal perforation within 6 months
- Known tumor invading gastrointestinal tract increasing risk of bleeding or perforation
- Current radiologic or clinical evidence of pancreatitis
- History of clinically significant non-healing wounds or ulcers within 28 days
- Uncontrolled hypertension within 14 days before registration
- Known endobronchial lesions or pulmonary hemorrhage within 3 months
- History of pneumonitis
- Tumor invading or encasing major blood vessels
- History of fracture within 28 days
- Known brain metastases or cranial epidural disease unless treated and stable
- Major surgery within 2 weeks or minor surgery within 10 days before registration with ongoing complications
- Allergic reaction to cabozantinib or similar compounds
- Active autoimmune disease requiring immune suppressive treatment
- Steroid use above 10 mg prednisone equivalents daily
- Use of strong CYP3A4 inhibitors or inducers within 14 days
- Use of herbal supplements or traditional Chinese medicines
- Active treatment with certain anticoagulants like coumarin agents within 5 days
- Patients discontinued or meeting discontinuation criteria for cabozantinib due to toxicity not eligible for crossover
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 65 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
2
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Suspended
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
6
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
7
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
8
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
9
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
10
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
11
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
12
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
13
Carle BroMenn Medical Center
Normal, Illinois, United States, 61761
Actively Recruiting
14
Carle Cancer Institute Normal
Normal, Illinois, United States, 61761
Actively Recruiting
15
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States, 60523
Actively Recruiting
16
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
17
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
18
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
19
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
20
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
21
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
Actively Recruiting
22
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
23
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
24
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
25
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Actively Recruiting
26
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
27
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
28
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
29
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
30
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
31
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
32
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
33
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
34
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Actively Recruiting
35
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
36
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
37
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
38
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States, 68123
Actively Recruiting
39
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States, 68118
Actively Recruiting
40
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
41
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
42
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
43
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
44
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
45
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
46
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
47
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
48
Duke Cancer Center Cary
Cary, North Carolina, United States, 27518
Actively Recruiting
49
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
50
Duke Cancer Center Raleigh
Raleigh, North Carolina, United States, 27609
Actively Recruiting
51
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
52
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
53
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States, 29316
Actively Recruiting
54
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
55
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States, 29640
Actively Recruiting
56
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
57
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States, 29605
Actively Recruiting
58
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Actively Recruiting
59
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Actively Recruiting
60
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Actively Recruiting
61
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
Actively Recruiting
62
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
63
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
64
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
65
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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