Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Recruiting now · Phase 2
Conditions studied: Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma, Recurrent Adrenal Cortical Carcinoma, Stage III Adrenal Cortical Carcinoma AJCC v8, Stage IV Adrenal Cortical Carcinoma AJCC v8, Unresectable Adrenal Cortical Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06900595
- Run by
- National Cancer Institute (NCI)
- People needed
- 48
- Starts
- 2026-02-22
- Expected to finish
- 2029-06-02
- Last updated by the study team
- 2026-08-07
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma
- STEP 1: Locally advanced unresectable or recurrent/metastatic disease
- STEP 1: Evaluable disease as defined by RECIST v 1.1
- STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed.
- Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be < 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll
- STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy
- STEP 1: Prior external beam radiation therapy (any area radiated within a month prior to study registration cannot be used as an index lesion and only growth outside of the radiation field can be considered for disease progression), systemic cytotoxic chemotherapy, targeted therapies will be allowed, as long as not administered within 14 days before study registration, and provided any acute treatment-related associated toxicities have recovered to ≤ grade 1 except for alopecia, peripheral neuropathy or other residual toxicities that are not deemed clinically significant
- STEP 1: Potential trial participants should have recovered from clinically significant adverse events, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment
- STEP 1: Age 12 years and above; and BSA ≥ 1.2m\^2
- STEP 1:
- Eastern Cooperative Oncology Group (ECOG) performance 0 - 2 (age 18 and above); or
- Patients 12 to <16 years of age will be assessed by the Lansky scale and should have a score ≥ 50; or
- Patients ≥ 16 to <18 years of age will be assessed by the Karnofsky scale, and should have a score ≥ 50
- STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mcL without colony stimulating factor support within 2 weeks prior
- Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
- STEP 1: Platelet count ≥ 100,000/mcL
- Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
- STEP 1: Hemoglobin ≥ 8 g/dL
- Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
- STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- For patients with known Gilbert's disease, bilirubin ≤ 3 mg/dL
- STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x upper limit of normal (ULN)
- STEP 1: Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg
- STEP 1: Calculated (Calc.) creatinine clearance ≥ 30 mL/min
- STEP 1: Mitotane level < 2 mg/L*
Where it is running
- Valley Children's Hospital — Madera, California, United States (enrolling)
- UCHealth University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
- Lurie Children's Hospital-Chicago — Chicago, Illinois, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Carle at The Riverfront — Danville, Illinois, United States (enrolling)
- Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States (enrolling)
- Carle Physician Group-Effingham — Effingham, Illinois, United States (enrolling)
- Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States (enrolling)
- Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States (enrolling)
- Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States (enrolling)
- Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States (enrolling)
- Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States (enrolling)
- Carle BroMenn Medical Center — Normal, Illinois, United States (enrolling)
- Carle Cancer Institute Normal — Normal, Illinois, United States (enrolling)
- Northwestern Medicine Oak Brook — Oak Brook, Illinois, United States (enrolling)
- Northwestern Medicine Orland Park — Orland Park, Illinois, United States (enrolling)
- Memorial Hospital East — Shiloh, Illinois, United States (enrolling)
- Carle Cancer Center — Urbana, Illinois, United States (enrolling)
- Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States (enrolling)
- UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States (enrolling)
- Saint Anthony Regional Hospital — Carroll, Iowa, United States (enrolling)
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States (enrolling)
- Iowa Methodist Medical Center — Des Moines, Iowa, United States (enrolling)
- UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.