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New treatment option for Clear Cell Renal Cell Carcinoma
Official title Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT07223541
What this study is testing
What is Cemiplimab 350 MG Intravenous Solution?
Cemiplimab 350 MG Intravenous Solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as Libtayo.
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 purpose of this research is to test the safety of PD-1 inhibitor cemiplimab with or without LAG-3 inhibitor fianlimab, and see what effects (good and bad) of cemiplimab either alone or combined with fianlimab has on patients with oligometastatic clear cell renal cell carcinoma after completion of radiation therapy.
- 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 18 and older
You may be able to join if
- Patient must be \>= 18 years of age.
- Patient must have a biopsy/pathologically (histologically or cytologically) proven diagnosis of clear cell renal cell carcinoma (ccRCC) prior to...
- Patient must have at least 1 and not more than 5 metastatic lesions measurable by RECIST v1.1, with imaging obtained within 45 days prior to...
- Patients with untreated brain metastasis measuring \<2cm in diameter (intracranial RANO-BM measurable disease required) and with minimal neurological...
- Patient must have documentation from a radiation oncologist confirming that all sites (metastases and primary tumor, if present) are amenable to...
You likely can't join if
- Patients with untreated brain metastasis \>2cm, significant neurological deficits and unamenable to surgical resection.
- Patient with variant histology renal cell carcinoma.
- Patient with metastasis invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum).
- Patients with more than 2 liver metastatic lesions, or liver lesions resulting in obstructive jaundice.
- Patient who have received any prior combination systemic therapy for metastatic RCC (including immune checkpoint inhibitors, tyrosine kinase...
- Patients who have received any check point inhibitor or immune therapies (i.e. Vaccine or other immune-oncology agent) within the last 12 months...
See the full eligibility criteria
Who can join
- Patient must be \>= 18 years of age.
- Patient must have a biopsy/pathologically (histologically or cytologically) proven diagnosis of clear cell renal cell carcinoma (ccRCC) prior to randomization.
- Patient must have at least 1 and not more than 5 metastatic lesions measurable by RECIST v1.1, with imaging obtained within 45 days prior to randomization.
- Patients with untreated brain metastasis measuring \<2cm in diameter (intracranial RANO-BM measurable disease required) and with minimal neurological symptoms. Patients with treated brain metastasis are eligible for the...
- Patient must have documentation from a radiation oncologist confirming that all sites (metastases and primary tumor, if present) are amenable to stereotactic body radiation therapy (SBRT).
- 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 are eligible for...
- 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 Association...
- All patients of childbearing potential must have a serum test within 14 days prior to randomization to rule out pregnancy.
- Patient must have the ability to understand and the willingness to sign a written informed consent document.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Patients must have adequate organ and bone marrow function per protocol.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for...
- For patients with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If no previous history, testing for HBV is not required for entry...
- For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. If no previous history, testing for HCV is not required for entry onto the study.
- Patients with prior radiation to sites but without evidence of progression will be allowed, however these RT-treated sites will not be treated on study. Patients who have had a prior nephrectomy can be included in the...
What rules you out
- Patients with untreated brain metastasis \>2cm, significant neurological deficits and unamenable to surgical resection.
- Patient with variant histology renal cell carcinoma.
- Patient with metastasis invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum).
- Patients with more than 2 liver metastatic lesions, or liver lesions resulting in obstructive jaundice.
- Patient who have received any prior combination systemic therapy for metastatic RCC (including immune checkpoint inhibitors, tyrosine kinase inhibitors or combinations)
- Patients who have received any check point inhibitor or immune therapies (i.e. Vaccine or other immune-oncology agent) within the last 12 months. Patients who have previously been treated for non-metastatic RCC with...
- Patients with active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids...
- Patients with no more than 1 prior systemic therapy for metastatic disease.
- Patients with active tuberculosis per protocol.
- Patients with uncontrolled hypertension (systolic blood pressure [BP] \> 190mmHg or diastolic BP \> 110mmHg).
- Patients requiring major surgery within 30 days prior to randomization.
- Patients with any serious (requiring hospital stay or long-term rehab) non-healing wound, ulcer, or bone fracture within 30 days prior to randomization.
- Patients with any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-STEMI [NSTEMI], cerebrovascular accident [CVA], etc.) events within 180 days prior to randomization.
- Patients with moderate or severe hepatic impairment (child-Pugh B or C).
- Patients with untreated pulmonary embolism (PE) or deep-vein thrombosis (DVT) is not allowed.
- Patients with unstable cardiac arrhythmia within 180 days prior to randomization.
- Patients with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to randomization.
- Patients with history of or active inflammatory bowel disease.
- Patients with history of connective tissue disease or other disease in which radiation therapy is contraindicated.
- Patient pregnant or breastfeeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
- Patients must not expect to conceive or father children and should use accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and...
- Patients with a history of myocarditis.
- Patients with troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline per protocol.
- Patients with history or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e.g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first...
- Patients with active infection requiring therapy.
- Patients with ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has...
- Patients with uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection per protocol.
- Patients with known hypersensitivity to the active substances or to any of the excipients.
- Patients who received a live vaccine within 30 days of planned start of study medication per protocol.
- Women who are fertile following menarche until becoming postmenopausal or women of childbearing potential (WOCBP\ ), unless permanently sterile must have a negative serum (beta-hCG) at screening per protocol.
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Oklahoma City, Oklahoma, 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 Oklahoma City, Oklahoma, 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.