Phase 2 Oesophageal 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 aged 18 or older who have a cancer diagnosis confirmed by laboratory tissue analysis, for which intravenous nivolumab has been approved by the FDA, and whose cancer doctor has recommended starting or continuing single-agent nivolumab treatment — with a willingness to switch to the under-the-skin (subcutaneous) form of nivolumab used in this study.
• People whose cancer falls into one of the following categories where nivolumab is used alone after surgery (adjuvant treatment): completely removed stage IIB/C, III, or IV melanoma; bladder or urinary tract cancer after full surgical removal with high recurrence risk; or completely removed esophageal or gastroesophageal junction cancer with remaining disease after pre-surgery chemotherapy and radiation.
• People with advanced or spreading cancer in one of these categories: kidney cancer (renal cell carcinoma) after prior anti-blood-vessel-growth therapy; non-small cell lung cancer after platinum-based chemotherapy has stopped working; advanced or spreading esophageal squamous cell cancer after prior chemotherapy; inoperable or spreading skin melanoma; advanced bladder or urinary tract cancer after platinum chemotherapy has stopped working or within 12 months of earlier platinum treatment; bladder/urinary tract cancer as a first treatment alongside cisplatin and gemcitabine chemotherapy (with subcutaneous nivolumab started alone after six cycles); head and neck squamous cell cancer that has returned or spread after platinum-based therapy; or colorectal cancer with specific genetic markers (MSI-H or dMMR) that has progressed after three prior chemotherapy drugs.
• People who have completed a combination of ipilimumab and nivolumab treatment and are moving to nivolumab maintenance therapy alone — including those who stopped ipilimumab due to side effects but whose doctor has determined they can continue on nivolumab alone — for conditions including advanced kidney cancer (intermediate or poor risk), inoperable or spreading melanoma, liver cancer (hepatocellular carcinoma) previously treated with sorafenib, or MSI-H/dMMR colorectal cancer.
• People receiving nivolumab alone after surgery, following pre-surgery nivolumab plus platinum-based chemotherapy, for removable non-small cell lung cancer (tumors 4 cm or larger, or with lymph node involvement) without certain specific genetic mutations (EGFR or ALK).
• People who have recovered from side effects of any previous cancer treatments, with only mild remaining effects (confirm with trial site for specific limits on what counts as acceptable).
• People with a general health and activity level rated as fully active or able to carry out light work (ECOG performance status 0 or 1).
• People whose blood test results for liver function (AST and ALT), bilirubin, kidney function, red blood cells, white blood cells, and platelets fall within the ranges required by the trial (confirm with trial site for specific values).
• People who live within 35 miles of the trial clinic, or within the area covered by the trial's supplier and paramedic network.
• People whose home has a reliable Wi-Fi connection that can support communication with the trial's remote monitoring centre.
• People willing and able to follow the study procedures and complete study questionnaires, either independently or with assistance.
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose and must be willing to use highly effective contraception throughout treatment and for at least 5 months after the last dose, and agree not to donate eggs during that time.

Who may not be able to join:

• People currently receiving any other cancer treatment — investigational or standard — beyond the specific nivolumab regimen described in this trial.
• People who need around-the-clock help with basic daily activities such as dressing, eating, or bathing.
• People with other serious ongoing illnesses or health conditions that the trial doctor believes would make participation unsafe or interfere with assessing treatment safety.
• People with uncontrolled ongoing conditions such as active infection, heart failure with symptoms, unstable chest pain, irregular heart rhythms, a heart attack within the last 6 months, wound healing problems, or mental health or social situations that would make following the study plan difficult.
• People who had a serious infection, including one requiring hospitalisation, within 4 weeks before joining.
• People with an active, known, or suspected autoimmune disease — though some exceptions apply, such as type 1 diabetes, thyroid conditions managed with hormone replacement only, or skin conditions like vitiligo or psoriasis not needing systemic (whole-body) treatment (confirm with trial site for specific exceptions).
• People taking corticosteroid medications at doses above the equivalent of 10 mg prednisone per day within the past 14 days, or other immune-suppressing medications within the past 30 days (inhaled or topical steroids and low-dose replacement steroids for adrenal or pituitary conditions are generally permitted).
• People with another active cancer being treated at the time of screening, or a history of another cancer that was active within the past 2 years — though some exceptions apply, such as certain early-stage skin cancers or non-invasive cancers that were fully treated.
• People who have had a donor organ transplant or a non-self stem cell or bone marrow transplant.
• People with active brain or lining-of-the-brain (leptomeningeal) cancer spread — though some exceptions apply for people whose brain metastases have been treated, are without symptoms, show no new growth on MRI for at least 4 weeks, and who meet specific steroid dose requirements (confirm with trial site).
• People whose brain disease was treated with whole-brain radiation.
• People expected to need major surgery during the trial.
• People who are pregnant or breastfeeding.
• People who have received a live attenuated vaccine within 30 days before joining (non-live vaccines, including COVID-19 vaccines, are generally allowed).
• People who are HIV-positive and have had an AIDS-defining illness in the past year, or whose CD4 immune cell count is below 350 cells/uL — though exceptions may apply for people on stable antiviral therapy with monitored counts (confirm with trial site).
• People with a known allergy or hypersensitivity to any component of the study drug.
• People who test positive for active hepatitis B virus infection.
• People who test positive for active hepatitis C virus with detectable virus in the blood (people with hepatitis C antibodies but no detectable active virus may be eligible — confirm with trial site).

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