Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from 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 are able to fully understand the study and are willing to sign a written consent form.
• People aged 18 years or older and under 80 years old.
• People who have a confirmed diagnosis of collecting duct carcinoma (a rare type of kidney cancer) that has spread, come back, or cannot be surgically removed, and who have already received at least one systemic (whole-body) treatment for the advanced disease.
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines (confirm with trial site).
• People who are generally able to carry out light daily activities — meaning they are not bedridden and can care for themselves (this is measured using a standard performance scale called ECOG PS 0 or 1).
• People whose blood, kidney, liver, thyroid, clotting, and heart function results fall within the ranges required by the trial (confirm with trial site for specific values).
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and procedures.
• Women of childbearing potential who have a negative pregnancy blood test within 7 days before starting treatment, and who agree to use highly effective contraception throughout the study and for 180 days after the last dose. Male participants whose partners could become pregnant must also agree to use highly effective contraception for the same period.

Who may not be able to join:

• People who have previously been treated with anti-PD-1, PD-L1 immunotherapy drugs, or the drug axitinib.
• People who have taken part in another clinical drug trial within the past 4 weeks (observational studies without treatment are generally acceptable — confirm with trial site).
• People who have had a major surgical procedure within the past 4 weeks, or who have not yet fully recovered from a previous surgery.
• People who have used traditional Chinese medicine or Chinese herbal preparations intended to treat cancer within the past 2 weeks.
• People who are currently taking high-dose steroid medications (above a certain threshold) or other drugs that suppress the immune system within the past 2 weeks (certain inhaled steroids may be acceptable — confirm with trial site).
• People who have had an organ transplant in the past, or who require long-term steroid treatment.
• People with certain hormone-related conditions (such as underactive thyroid, adrenal insufficiency, or pituitary problems) that can only be controlled with hormone replacement therapy, or with Type 1 diabetes, psoriasis, or a skin pigmentation condition requiring systemic treatment.
• People who have not yet recovered from side effects of previous cancer treatments (minor or permanent side effects that are not expected to worsen may be acceptable — confirm with trial site).
• People who have had another active cancer requiring treatment within the past 5 years (some early-stage or treated skin cancers and certain other cancers may be acceptable — confirm with trial site).
• People with active brain or spinal cord metastases (cancer that has spread to the brain or its lining). People whose brain metastases have been stable for at least 3 months after treatment, and who meet other specific requirements, may be eligible — confirm with trial site.
• People with poorly controlled high blood pressure (systolic reading at or above 150 mmHg and/or diastolic reading at or above 90 mmHg).
• People who have had a serious heart or blood vessel event within the past 6 months, such as a heart attack, unstable chest pain, heart stent or bypass surgery, severe heart failure, stroke, or a mini-stroke. People with a specific abnormal heart rhythm reading (QTc ≥ 480 ms) are also excluded.
• People who have had active or significant bleeding within the past 30 days.
• People who have had a blood clot in a deep vein or in the lungs within the past 6 months.
• People who have had a blood clot in an artery within the past 12 months.
• People with significant digestive system problems, such as conditions affecting how oral medications are absorbed, active stomach ulcers treated in the past 6 months, active gastrointestinal bleeding in the past 3 months, inflammatory bowel disease, or a risk of bowel perforation.
• People with a history of, or current, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People with an active infection currently requiring treatment with antibiotics or other systemic medications, or people with a known history of HIV (positive HIV antibody). People with hepatitis B or C may be eligible under certain conditions — confirm with trial site.
• People who have received a live virus vaccine (such as for measles, chickenpox, yellow fever, or BCG) within the past 30 days (inactivated vaccines are generally acceptable).
• People with a known history of serious allergic reactions to antibody-based drugs or targeted therapy drugs called TKIs.
• People with a known history of serious psychiatric illness or drug abuse.
• People with wounds that are not healing adequately.
• People who are currently taking, or are expected to need, certain medications that strongly interact with how the study drug is processed by the body, or medications known to affect heart rhythm (confirm with trial site for the specific drug list).
• People with any other medical condition, ongoing treatment, or abnormal test result that the trial doctor believes could affect the study results or would make participation unsafe.

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