Phase 1 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:

• Adults aged 18 or older (any gender)
• People whose overall health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0, 1, or 2)
• People who have at least one tumour or group of tumours large enough to be safely biopsied, and whose tumour(s) can be reached with image-guided biopsy (using CT, ultrasound, or MRI)
• People who have at least one tumour that can be measured on a scan, with recent brain and body imaging completed within 45 days before the first planned vaccine dose
• People whose kidneys are functioning adequately, as shown by blood test results (confirm with trial site)
• People whose liver function blood test results are within acceptable ranges (confirm with trial site)
• People with no more than mild breathing difficulty, and blood oxygen levels of 92% or above while breathing normal air; if breathing tests are done, results must meet specific minimum levels (confirm with trial site)
• People aged 60 or older who have had a heart pumping function test (echocardiogram or MUGA scan) within the past 60 days showing the heart is pumping at 50% or more; for people under 60, this test is at the treating doctor's discretion
• People whose blood cell counts (white cells, red cells, and platelets) meet minimum levels required by the trial (confirm with trial site)
• People whose side effects from previous cancer treatments have settled down to a mild or manageable level
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures
• People who are able to understand the study and provide written consent to participate
• People who agree to use reliable contraception throughout the study and for at least 5 months after the last dose, if there is any possibility of pregnancy; anyone who becomes pregnant during the study must inform their study doctor immediately
• For people with melanoma specifically: People with a confirmed diagnosis of advanced or unresectable melanoma (stage IIIC, IIID, or stage IV) of the skin, hands/feet, eye surface, or mucous membranes, confirmed by pathology review at the trial centre (Fred Hutchinson Cancer Center or University of Washington Medical Center); people who have already received standard recommended treatment but still have active disease after at least one round of therapy; people whose BRAF gene mutation status is known; and people whose melanoma continued to grow or returned during or after treatment with a PD-1 or PD-L1 immunotherapy drug, meeting specific criteria for treatment resistance (confirm with trial site)
• For people with breast cancer specifically: People with a confirmed diagnosis of stage IV hormone receptor-positive, HER2-negative breast cancer, confirmed by pathology review at the trial centre, who have already received at least one round of treatment for metastatic disease but whose disease has continued or progressed
• For people with non-small cell lung cancer (NSCLC) specifically: People with a confirmed diagnosis of unresectable stage III or stage IV NSCLC, confirmed by pathology review at the trial centre, who have had genetic testing for certain tumour mutations (EGFR, ROS1, ALK, KRAS, BRAF); people who have already received at least one line of treatment including a PD-1 or PD-L1 immunotherapy drug and whose disease has progressed or returned (specific timing rules apply regarding when that treatment was given — confirm with trial site)

Who may not be able to join:

• People of childbearing potential or fertile males who are unwilling or unable to use two reliable forms of contraception for the duration of the study and for at least 5 months after the last dose
• People who have previously had a severe (grade 4) immune-related side effect from cancer immunotherapy, except for hormone-related side effects managed with replacement therapy or certain asymptomatic lab abnormalities
• People who had to permanently stop a PD-1 immunotherapy drug due to a serious (grade 3) immune-related side effect
• People who still have unresolved immune-related side effects from previous immunotherapy (with some exceptions such as stable skin pigment changes or managed hormone conditions); people who needed steroid treatment for such side effects must have been free of related symptoms for at least 4 weeks after stopping steroids
• People with uncontrolled pain caused by their tumour (pain must be stable and well-managed before joining)
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained more than once every 28 days (permanent drainage tubes are allowed)
• People with brain metastases that are currently causing symptoms; people with previously treated brain metastases may be considered if treatment is complete, steroids have been stopped for at least 4 weeks, and they have been neurologically stable for at least 1 month confirmed by MRI
• People whose disease is rapidly worsening or expected to worsen quickly over the coming months despite additional bridging treatment
• People with known primary immune system deficiency disorders affecting immune cells (confirm with trial site)
• People who have previously received a bone marrow transplant from a donor, or a solid organ transplant
• People who have tested positive for HIV
• People who currently have an active infection causing a fever above 38.1°C, or an unexplained fever above 38.1°C, unless the fever has been below that level for at least 5 days before starting treatment
• People with an active uncontrolled infection (note: people with a history of hepatitis C with successful treatment and undetectable virus, or hepatitis B well-controlled on medication, may still be considered)
• People with a history of autoimmune disease that has not been well-controlled with treatment in the past 12 months (certain conditions such as stable hypothyroidism on thyroid replacement, controlled type 1 diabetes, or skin-only conditions like eczema or psoriasis may still be eligible — confirm with trial site)
• People who have taken immune-suppressing medications (such as prednisone above 10 mg/day or similar drugs) within 2 weeks before screening (some low-dose or topical steroid use may be allowed — confirm with trial site)
• People whose blood clotting test results fall outside acceptable ranges, unless they are already on blood-thinning medication with results within the intended treatment range and no history of severe bleeding (common antiplatelet medicines like aspirin are generally allowed)
• People with other medical, social, or mental health circumstances that the study doctor determines would make participation unsafe or not appropriate
• People who have not had a negative pregnancy blood test within 14 days before joining the trial, if there is any possibility of pregnancy
• People who are currently breastfeeding or plan to breastfeed during the study
• People who have received a live vaccine within 30 days before enrolling
• People with any underlying health condition that, in the study doctor's opinion, would make participation unsafe or interfere with study assessments
• For people with melanoma specifically: People with uveal or choroidal melanoma (a type affecting the inside of the eye) are not eligible for this trial
• For people with breast cancer specifically: People with active symptoms from their disease, including symptomatic lung metastases, bone marrow involvement causing low blood counts, or significant liver metastases causing liver dysfunction
• For people with NSCLC specifically: People whose tumour has certain specific genetic changes (activating EGFR mutations, or ROS1 or ALK alterations), as these are associated with lower likelihood of benefit from immune therapy

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