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New treatment option for Renal Cell Carcinoma
Official title Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT05188118
What this study is testing
What is Cabozantinib?
Cabozantinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for 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
- This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks [Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG]).
- Phase 1: an early, usually small safety study
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Age ≥ 18 years at the time of study entry
- Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
- ECOG performance status of 0 or 1 or KPS of at least 80%
- Life expectancy ≥ 12 weeks
- Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (stage IV) RCC with predominantly clear cell...
You likely can't join if
- Prior treatment with cabozantinib, nivolumab, ipilimumab, or any other systemic kidney cancer directed therapy for advanced disease (i.e. must be...
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor...
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study...
- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for...
- Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor...
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of study entry
- Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
- ECOG performance status of 0 or 1 or KPS of at least 80%
- Life expectancy ≥ 12 weeks
- Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (stage IV) RCC with predominantly clear cell component (sarcomatoid differentiation \<50%) a. Patients with...
- Patients with favorable, intermediate, or poor risk categories as defined by the MSKCC Prognostic Model or the IMDC consortium (Appendix A) will be eligible for the study
- Evidence of measurable disease per RECIST 1.1 (i.e., ≥1 malignant tumor mass ≥10 mm with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm)
- Adequate normal organ, marrow and coagulation function based on below labs within 14 days before first dose of study treatment:
- Hgb ≥ 9.0g/dL
- White blood count ≥ 2500/ µL
- ANC ≥1 x 109/L (≥1500/L) without growth factor support
- Plt count ≥ 100 x 109 /L (≥100,000/L) without transfusion
- Total serum bilirubin ≤1.5 x institutional ULN; Gilbert's disease, Total serum bilirubin ≤3 x institutional ULN
- Serum transaminases (AST/ALT) ≤3 x the institutional ULN; ALP ≤5 x the institutional ULN with documented bone metastasis
- Serum albumin ≥ 2.8 g/dl
- PT/INR or PTT test ≥ 1.3 x the laboratory ULN
- Serum creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 30 mL/min
- UPCR ≤ 1mg/mg (≤113.2 mg/mmol) or 24-h urine protein ≤ 1 g
- Representative FFPE tumor block (archival or recent acquisition) with an associated anonymized pathology report must be available for central testing.
- Recovery to baseline or ≤ Grade 1 (CTCAE v. 5.0) from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
- Sexually active fertile people and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the...
- Female people of childbearing potential must not be pregnant at screening (negative serum or urine pregnancy test within 2 weeks prior to the first dose of therapy). Female people are considered to be of childbearing...
- Documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- Documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \ 40 mIU/mL to confirm menopause).
- Note: documentation may include review of medical records, medical examinations, or medical history interview by the study site
What rules you out
- Prior treatment with cabozantinib, nivolumab, ipilimumab, or any other systemic kidney cancer directed therapy for advanced disease (i.e. must be treatment naïve for advanced disease; adjuvant treatment post definitive...
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) within 4 weeks or five half-lives of the...
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment; ongoing clinically relevant...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment.
- Concomitant anticoagulation with coumarin 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.
- 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...
- The subject has uncontrolled, significant inter-current or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders: I. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias. II. Uncontrolled hypertension defined as sustained blood pressure \>...
- GI disorders including those associated with a high risk of perforation or fistula formation: I. The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g...
- Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study...
- Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
- Lesions invading or encasing any major blood vessels.
- Other clinically significant disorders that would preclude safe study participation.
- Serious non-healing wound/ulcer/bone fracture.
- Uncompensated/symptomatic hypothyroidism.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
- Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment...
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms per ECG within 14 days before first dose of study treatment. Note: If a single ECG shows a QTcF with an absolute value \> 500 ms, two...
- Current or prior use of immunosuppressive medication within 21 days before the first dose of protocol therapy, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological...
- Pregnant or lactating females.
- Inability to swallow tablets.
- History of hypersensitivity to cabozantinib, nivolumab, ipilimumab, lenvatinib, everolimus, or any excipient or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized...
- Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable...
- History of leptomeningeal carcinomatosis.
- Treatment with systemic immune-stimulatory agents (including but not limited to IL-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment.
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving protocol therapy or anticipation that such a live, attenuated vaccine will be required during the study.
- Any prior Grade ≥3 irAE while receiving any previous immunotherapy agent, or any unresolved irAE \> Grade 1.
- Active or prior documented autoimmune disease within the past 2 years including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory...
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or history of GI disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study...
- History of primary immunodeficiency.
- History of prior allogeneic stem cell or solid organ transplant.
- Participation in another clinical study with an investigational product within 28 days prior to enrolment in the study.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. 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.