Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with advanced or metastatic clear cell kidney cancer (confirmed by a tissue or cell sample) and have already received at least one prior treatment for their advanced disease, including a type of immunotherapy called a PD-1/PD-L1 checkpoint inhibitor.
• People in Group 1 (Cohort 1) whose prior treatments did not include a drug targeting a protein called VEGF or a protein called HIF-2α.
• People in Group 2 (Cohort 2) whose cancer got worse during or after at least one prior treatment that included a VEGF-targeting drug.
• People in Group 2 (Cohort 2) who previously received a HIF-2α inhibitor (this type of treatment disqualifies someone from Group 1 but not Group 2).
• People whose cancer has shown signs of getting worse after their most recent treatment.
• People who received immunotherapy as an early-stage (adjuvant) treatment and whose cancer progressed while on that therapy may be eligible for Group 1; people whose cancer returned after completing adjuvant therapy must have since received a PD-1/PD-L1 checkpoint inhibitor in the advanced setting to be considered eligible.
• People who have at least one area of cancer that can be measured on a scan, meeting specific size requirements (confirm with trial site).
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale called the ECOG performance status of 2 or below.
• People aged 18 or older.
• People whose blood tests show that their liver, kidneys, bone marrow, and blood clotting are functioning at adequate levels (confirm with trial site for specific values).
• People with a known history of heart disease or prior treatment with heart-affecting drugs, whose heart function is assessed as class 2B or better on a standard medical rating scale.
• People with a known history of hepatitis B, provided the virus is undetectable in the blood while on appropriate antiviral treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People with a history of significant psychiatric illness, provided the treating doctor judges them able to fully understand the study and its risks.
• People who are able and willing to use effective contraception for the duration of the study and for 90 days after the last dose of the study drug, as required by the study guidelines.
• People who test negative for pregnancy before starting the study (where applicable).
• People living with HIV who are on effective antiviral treatment with an undetectable viral load within the past 6 months.
• People who are willing and able to sign a consent form agreeing to participate in this trial and two related studies.

Who may not be able to join:

• People who have been diagnosed with another cancer in the past 2 years, with some exceptions for certain very early-stage or low-risk cancers (confirm with trial site).
• People who have had major surgery or serious physical injury within 4 weeks before enrolling, or who are planning major surgery within 4 weeks after the first dose; also people who have had minor procedures in the 3 days before enrolling (with some exceptions).
• People with high blood pressure that remains at or above a certain level (150/100 mmHg) even after taking blood pressure medication.
• People who have had significant bleeding problems within 4 weeks before enrolling, including coughing up blood, significant nosebleeds, or blood in the urine linked to a blockage, or who have a known tendency to bleed or clot abnormally.
• People who have had serious heart problems — such as unstable chest pain, a heart attack, heart failure, or problems with blood vessels — that required a hospital stay within the past 12 months.
• People who have had serious stomach or digestive problems within the past 6 months, such as bleeding ulcers, non-healing wounds, abnormal connections between organs (fistulas), or abscesses in the abdomen.
• People who have had a serious blood clot in an artery or major vein, a mini-stroke or stroke, a severe hypertensive crisis, or a severe flare-up of chronic lung disease within the past 12 months.
• People who have had a hole or rupture in the digestive tract, a bowel blockage, or major bowel surgery within the past 6 months.
• People with brain metastases that are causing symptoms, are bleeding, are larger than 1.5 cm, or that are not stable; people who require steroid medication to manage brain or nervous system involvement. (People with treated and stable brain metastases that have not recurred for at least 4 weeks and who are not on steroids above a low maintenance dose may be considered eligible — confirm with trial site.)
• People with a current or past history of inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• People currently participating in another clinical trial involving an investigational treatment.
• People with an active autoimmune disease that required systemic treatment within the past 2 years, with some exceptions for hormone replacements and certain inhaled or local treatments.
• People who have previously received an organ transplant or bone marrow transplant from another person.
• People who have had a serious infection requiring hospitalisation within the past 4 weeks, or an active infection requiring systemic antibiotic or antifungal treatment within the past 2 weeks.
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that is causing symptoms (people with a drainage catheter in place may be considered — confirm with trial site).
• People with a known history of serious allergic reactions to medications similar to the study drug, including severe reactions to other monoclonal antibody treatments.
• People with active hepatitis C (detectable virus in the blood).
• People with pre-existing nerve damage (peripheral neuropathy) that is moderate or worse in severity.
• People who are pregnant.
• People who are breastfeeding or plan to breastfeed during the study.
• People who still have moderate or severe side effects from previous cancer treatments that have not resolved.
• People with any medical, surgical, or psychiatric condition that, in the treating doctor's opinion, could interfere with their safety or ability to complete the study.

Important: Always verify eligibility with the trial site directly before applying.