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New treatment option for Metastatic Renal Cell Carcinoma
Official title A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)
ClinicalTrials.gov ID: NCT06835972
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for metastatic renal cell 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
- The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC) and translocation-associated renal cell cancer (tRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years at the time of informed consent
- Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the...
- Signed and dated IRB-approved Informed Consent Form
- Patient must have a histologically confirmed diagnosis of metastatic stage IV clear cell renal cell carcinoma or metastatic stage IV...
- Patient should have availability of archival tissue that enables definitive diagnosis of ccRCC or tRCC, per review at participating site, accompanied...
You likely can't join if
- Prior treatment with abemaciclib or cabozantinib.
- Receipt of any type of anti-cancer antibody, cytotoxic anticancer therapy, or any other investigational agents within 2 weeks of treatment start or 5...
- Symptomatic brain metastasis or leptomeningeal disease requiring steroid use. Patients are eligible if they are neurologically stable for 4 weeks...
- Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or early stage cancers...
- Patients requiring moderate or strong CYP3A4 inducers or inhibitors (https://druginteractions.medicine.iu.edu/MainTable.aspx).
- Patients with a history of HIV infection who are not on a stable HAART regimen and/or are requiring antimicrobials for prevention of opportunistic...
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of informed consent
- Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the patient cannot
- Signed and dated IRB-approved Informed Consent Form
- Patient must have a histologically confirmed diagnosis of metastatic stage IV clear cell renal cell carcinoma or metastatic stage IV translocation-associated renal cell carcinoma.
- Patient should have availability of archival tissue that enables definitive diagnosis of ccRCC or tRCC, per review at participating site, accompanied by an associated pathology report. Specimens can be collected by...
- Patients must have at least one extra-skeletal, extracranial measurable lesion as defined by RECIST v1.1
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patients must have received prior therapy with at least 2 approved systemic agents and a maximum of 3 prior lines of systemic therapy. Prior adjuvant therapy is permitted.
- Patient must have progressed on 1 prior PD-1 or PD-L1 targeted treatment and prior VEGFR directed TKI therapy
- Patients must have recovered to baseline or \< Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically non-significant and/or stable on supportive therapy (See...
- Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration.
- The patient can swallow oral medications.
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
- ANC ≥ 1500 cells/μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
- WBC counts ≥ 2500/μL and ≤ 15,000/μL without G-CSF
- Absolute Lymphocyte count \> 0.5K/mcL
- Platelet count ≥100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 X upper limit of normal (ULN). ALP ≤ 5 x ULN if patient has documented bone metastases.
- Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 2 x ULN may be enrolled.
- Serum albumin ≥ 2.8 g/dl
- (PT)/INR or partial thromboplastin time (PTT) test \< 1.3x the laboratory ULN
- Estimated Glomerular Filtration Rate (eGFR) ≥ 30mL/min using the CKD-EPI formula https://www.kidney.org/professionals/kdoqi/gfr\_calculator.
- Urine protein/creatinine ratio (UPCR) ≤ 1.8 mg/mg
- Women of childbearing potential must not be pregnant or lactating at screening.
- Women of childbearing potential who are sexually active with a non-sterilized male partner must use two methods of effective contraception from screening and must agree to continue using such precautions for 4 months...
- Sexually active participants must agree to use medically accepted methods of contraception (i.e. barrier methods including condoms, female condom, or diaphragm with spermicidal gel) during the study and for 4 months...
What rules you out
- Prior treatment with abemaciclib or cabozantinib.
- Receipt of any type of anti-cancer antibody, cytotoxic anticancer therapy, or any other investigational agents within 2 weeks of treatment start or 5 half-lives, whichever is shorter. For immune checkpoint inhibitors...
- Symptomatic brain metastasis or leptomeningeal disease requiring steroid use. Patients are eligible if they are neurologically stable for 4 weeks, have completed radiation therapy or surgery, and recovered from side...
- Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or early stage cancers previously treated with curative intent.
- Patients requiring moderate or strong CYP3A4 inducers or inhibitors (https://druginteractions.medicine.iu.edu/MainTable.aspx).
- Patients with a history of HIV infection who are not on a stable HAART regimen and/or are requiring antimicrobials for prevention of opportunistic infections and/or have CD4 count below 250 or a detectable HIV viral load
- Patients with active hepatitis B or hepatitis C infection with detectable viral load by PCR
- Active systemic bacterial infection (requiring systemic antibiotics at time of initiating study treatment) or fungal infection.
- History of significant cardiovascular events or active cardiovascular disease; including myocardial infarction within the previous 6 months, unstable arrhythmias, unstable angina, prior sudden cardiac arrest, LVEF \<...
- Uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment.
- Significant arterial disease (e.g., stroke, transient ischemic attack, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 470 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment. Note: If a single ECG shows a QTcF with an absolute value \>...
- Concomitant anticoagulation with coumadin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants...
- Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
- Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in people without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week...
- Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose. Evidence of...
- Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 6 weeks before first dose of study treatment. Completeness of wound healing from any surgery must be ascertained. There must be a minimum of...
- Evidence of tumor invading the gastrointestinal tract, active peptic ulcer disease, active inflammatory bowel disease, active diverticulitis, active cholecystitis, symptomatic/active cholangitis or appendicitis, acute...
- Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
- Patients with a history of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment.
- The patient has tumor invading or encasing any major blood vessels, with exception of renal vessels ipsilateral to the primary renal tumor.
- The patient has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus) at time of study screening.
- Patients with malabsorption syndrome.
- Patients with a serious non-healing wound/ulcer/bone fracture.
- Patients with active COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to first dose of study treatment.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Radiation therapy for bone metastasis within 2 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. people with clinically relevant...
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 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.