Phase 2 Melanoma 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 give written consent and are willing and able to follow the trial visit schedule and procedures.
• People who have been confirmed through laboratory testing (from a tissue sample) to have mucosal melanoma, where all known primary and/or spread-related tumours have been fully surgically removed with clear margins.
• People whose tumour tissue tests positive for a protein called PD-L1 (with a score called CPS of 1 or higher).
• People who receive their first trial treatment only after their surgery wound has fully healed, and within 13 weeks of their melanoma surgery (a small extension of up to 7 days may be considered in unexpected circumstances, at the trial team's discretion).
• People whose complete tumour removal has been confirmed by physical examination and imaging scans within 4 weeks before being enrolled into the trial.
• People who had melanoma that had spread to the brain, where after surgery (with or without radiotherapy), brain scans show no sign of the cancer returning for at least 4 weeks — and where any steroid medications (such as prednisone) used to manage brain swelling have been stopped at least 14 days before starting the trial treatment.
• People who, if radiotherapy to lymph nodes was needed after melanoma surgery, had that radiotherapy completed within 13 weeks of lymph node removal and before starting the trial treatment — provided that wound healing was not delayed by the radiotherapy.
• People aged 18 years or older.
• People whose expected survival is at least 12 weeks.
• People who are reasonably active and able to care for themselves, as measured by a standard scale called the ECOG Performance Status — specifically those scoring 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work).
• People whose blood, liver, kidney, and clotting function meet specific laboratory thresholds measured within 7 days before enrolment, without having received corrective treatments such as blood products or growth factors in the 14 days before those tests (confirm specific values with trial site).
• People of childbearing potential (female participants, or male participants whose partners could become pregnant) who are willing to use effective contraception throughout the treatment period and for 6 months after treatment ends.

Who may not be able to join:

• People who have previously been treated with any anti-PD-1 or anti-PD-L1/2 antibody medication.
• People who have previously been treated with interferon.
• People who currently have an overactive or underactive thyroid gland — though people with a stable underactive thyroid managed by hormone replacement therapy may still be considered eligible (confirm with trial site).
• People who are currently participating in another clinical trial.
• People who have received any experimental drug within 4 weeks before the first trial treatment.
• People who have used immune-suppressing medications within 4 weeks before the first trial treatment, with the exception of low-dose steroid creams, nasal sprays, inhalers, or very low-dose oral steroids at standard physiological levels (no more than 10 mg per day of prednisone or equivalent).
• People who have received a live vaccine within 4 weeks before the first trial treatment, or who plan to receive one during the trial.
• People who have undergone major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before the first trial treatment, or who have wounds, ulcers, or fractures that have not yet healed.
• People who have had a hole or abnormal opening form in the gastrointestinal tract (gut) within 6 months before the first trial treatment.
• People who have previously received systemic cancer treatments such as chemotherapy, targeted therapy, or biological therapies — though certain Chinese herbal medicines or immune-modulating drugs may be allowed after a 2-week washout period (confirm with trial site).
• People who have an active autoimmune disease, or who have had one in the past 2 years — though certain conditions that did not require systemic treatment (such as vitiligo, psoriasis, hair loss, or Grave's disease), a stable underactive thyroid managed only with hormone replacement, or type 1 diabetes managed only with insulin may still be considered (confirm with trial site).
• People with a known history of a primary immune deficiency condition.
• People who have had an organ transplant (other than a corneal transplant) or a bone marrow/stem cell transplant.
• People with a history of serious lung conditions such as pulmonary fibrosis, interstitial lung disease, dust-related lung disease, or drug-related lung damage that severely affects lung function.
• People with a known history of severe allergic reactions to monoclonal antibody medications, interferons, or any ingredient in the trial drugs (including sintilimab or interferon).
• People with uncontrolled fluid build-up in body cavities such as around the lungs or in the abdomen, which cannot be managed by drainage before enrolment.
• People who are HIV positive.
• People with active hepatitis B (confirmed by specific virus levels in the blood) or active hepatitis C (confirmed by a positive antibody test and detectable virus in the blood) — people who test positive for hepatitis C antibodies but have no detectable virus may still be considered (confirm with trial site).
• People with active tuberculosis of the lungs.
• People with active or uncontrolled serious infections.
• People with moderate to severe heart failure causing symptoms, or with uncontrolled irregular heartbeat.
• People with high blood pressure that remains uncontrolled despite treatment (systolic pressure of 160 mmHg or above, or diastolic pressure of 100 mmHg or above).
• People who have had a serious blood clot or blockage in an artery — such as a heart attack, unstable chest pain, pulmonary embolism, or stroke — within 6 months before enrolment.
• People who have had a serious blood clot in a deep vein or other severe clotting event within 3 months before enrolment (note: clots related to implanted port devices or surface veins are generally not considered severe for this purpose — confirm with trial site).
• People with uncontrolled metabolic conditions, serious disease in other organs, or effects from previous cancer treatment that the trial doctor judges would make participation unsafe or make it difficult to assess the results.
• People with serious liver conditions such as brain complications from liver disease, kidney failure caused by liver disease, or advanced cirrhosis (Child-Pugh Class B or C).
• People with a history of gut perforation or abnormal openings, bowel blockage, extensive bowel removal, Crohn's disease, ulcerative colitis, or long-term chronic diarrhoea within 6 months before enrolment.
• People with other serious acute or chronic illnesses, mental health conditions, or abnormal lab results that could increase the risks of participating or make it difficult to assess the trial results, as determined by the trial doctor.
• People with a history of another cancer, unless it was fully treated at least 5 years ago with a very low chance of returning, was a non-melanoma skin cancer or certain skin lesion with no signs of return after adequate treatment, or was a localised in-situ cancer that was fully treated with no signs of return.
• People who are pregnant or breastfeeding.
• People whom the trial doctor considers unsuitable for participation for any other reason.

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