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New treatment option for Locally Advanced Adrenal Cortical Carcinoma
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
ClinicalTrials.gov ID: NCT06900595
What this study is testing
What is Cabozantinib?
Cabozantinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced adrenal cortical carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join 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...
- Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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\
- Only applicable for patients who have received mitotane ≤ 6 months prior to registration
- STEP 1: Must have assessment of adrenal steroid production within 3 months prior to registration as patients will be stratified based on corticosteroid production
- Patients will be classified as corticosteroid producing if random plasma adrenocorticotropic hormone (ACTH) is \ 20 mcg/dL in the absence of anti-cortisol therapy. Patients already on anti-cortisol therapy will be...
- STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects based on animal reproduction studies. Therefore, for women of childbearing potential...
- STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart...
- STEP 1: No known history of congenital long QT syndrome
- STEP 1: No known history of myocarditis
- STEP 1: No myocardial infarction (MI) or unstable angina within 6 months of registration
- STEP 1: No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known...
- STEP 1: No history of gastrointestinal (GI) perforation within 6 months of registration
- STEP 1: No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration
- STEP 1: No current radiologic or clinical evidence of pancreatitis
- STEP 1: No history of clinically significant non-healing wounds or ulcers within 28 days of registration
- STEP 1: No uncontrolled hypertension within 14 days of registration (defined as sustained systolic blood pressure (SBP) ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg despite optimal medical management)
- STEP 1: No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. (CT with contrast is recommended to evaluate...
- STEP 1: No history of pneumonitis
- STEP 1: No known tumor invading or encasing any major blood vessels
- STEP 1: No history of fracture within 28 days of registration
- STEP 1: No known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks after major surgery (e.g., removal or...
- STEP 1: Major surgery (e.g., laparoscopic nephrectomy, GI surgery, within 2 weeks before registration. Minor surgeries within 10 days before registration. Patients with clinically relevant ongoing complications from...
- STEP 1: Verbalizes the ability to swallow oral tablet formulation
- STEP 1: No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib
- STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen will be...
- STEP 1: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
- STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- STEP 1: No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These...
- immune related neurologic disease,
- multiple sclerosis,
- autoimmune (demyelinating) neuropathy,
- Guillain-Barre syndrome (GBS), myasthenia gravis,
- systemic autoimmune disease such as systemic lupus erythematosus (SLE),
- connective tissue diseases,
- scleroderma, inflammatory bowel disease (IBD),
- Crohn's, ulcerative colitis,
- patients with a history of toxic epidermal necrolysis (TEN),
- Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease,
- Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible,
- Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or...
- STEP 1: No steroid use \> 10 mg prednisone equivalents daily. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by...
- STEP 1: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
- STEP 1: Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
- STEP 1: Herbal supplements and traditional Chinese medicines are not allowed
- STEP 1: Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration...
- STEP 2 (CROSSOVER): Patients must have demonstrated radiographic progression of disease on cabozantinib monotherapy (Arm A) per RECIST version 1.1 criteria
- Patients must cross-over to Arm C within 4 weeks (+/- 1 week) after radiographic documented progression and do not need to have a repeat radiographic assessment prior to starting cabozantinib and cemiplimab (REGN2810)...
- STEP 2 (CROSSOVER): Patients that were discontinued on cabozantinib, or currently meet criteria for discontinuation of cabozantinib due to toxicity are not eligible to cross-over.
- Note: Patients who underwent dose reduction of cabozantinib during treatment on Arm A will not re-escalate dose at or after cross-over to Cabo-Cemiplimab (REGN2810) (Arm B)
- STEP 2 (CROSSOVER): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Madera, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
- DeKalb, Illinois, United States
- Effingham, Illinois, United States
- Geneva, Illinois, United States
- Glenview, Illinois, United States
- Grayslake, Illinois, United States
- Lake Forest, Illinois, United States
- Mattoon, Illinois, United States
- Normal, Illinois, United States
- Oak Brook, Illinois, United States
- Orland Park, Illinois, United States
- Shiloh, Illinois, United States
- Urbana, Illinois, United States
- Warrenville, Illinois, United States
- Ankeny, Iowa, United States
- Carroll, Iowa, United States
+ 40 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Madera, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Danville, Illinois, United States; DeKalb, Illinois, United States and 54 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.