Phase 1 Pancreatic 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 understand the study information and agree to take part voluntarily.
• People who are willing and able to attend all required study visits and follow the study procedures.
• Adults aged 18 or older.
• People whose cancer has not significantly affected their ability to carry out daily activities (doctors use a scoring system called ECOG, and a score of 0 or 1 means largely able to care for oneself).
• People with certain advanced or metastatic (spread) cancers — depending on which part of the trial they are joining, eligible cancer types include non-small cell lung cancer (NSCLC), a type of skin cancer called cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma, melanoma, triple negative breast cancer (TNBC), pancreatic cancer, or head and neck cancer.
• For the combination treatment parts of the trial (Parts 1B and 1C), people whose advanced NSCLC has continued to grow after treatment with a specific type of immunotherapy (called anti-PD-1 or PD-L1 therapy), given with or without chemotherapy.
• People whose cancer has grown or returned after receiving the standard treatments for their specific cancer type — the exact prior treatments required differ by cancer type, and the trial site can confirm the details for each.
• For NSCLC: people whose cancer has grown after standard treatments including platinum-based chemotherapy and immunotherapy checkpoint treatment (given together or one after the other); people whose tumours have certain gene changes (such as EGFR, ALK, ROS-1, BRAF, RET, MET, or KRAS) must also have received the relevant targeted therapy before joining.
• For Part 1B (MEM-288 plus nivolumab): people whose NSCLC first progressed more than 84 days after starting their most recent anti-PD-1 or PD-L1 immunotherapy.
• For Part 1C (MEM-288 plus docetaxel): people whose NSCLC first progressed during anti-PD-1 or PD-L1 immunotherapy (with or without chemotherapy), or who progressed after first receiving immunotherapy and then platinum chemotherapy.
• For cSCC: people whose cancer has grown after standard treatments including platinum-based chemotherapy and/or immunotherapy checkpoint treatment.
• For Merkel cell carcinoma: people whose cancer has grown after standard immunotherapy checkpoint treatment.
• For melanoma: people who have previously received a BRAF inhibitor (if their melanoma has a BRAF V600E gene change), and who have also received anti-PD-1/PD-L1 immunotherapy (alone or in combination with other treatments).
• For pancreatic cancer: people whose cancer has grown after chemotherapy that included gemcitabine or a fluorouracil (5-FU)-based treatment (including capecitabine).
• For triple negative breast cancer (TNBC): people who have previously received treatment containing a taxane and/or anthracycline (either for advanced, metastatic, or earlier-stage disease).
• For head and neck cancer: people who have previously received a platinum-based chemotherapy regimen and anti-PD-1/PD-L1 immunotherapy (alone or combined with chemotherapy) for locally advanced or metastatic disease.
• People whose cancer has progressed after treatment with at least one PD-1 or PD-L1 immunotherapy drug, regardless of a marker called PD-L1 expression — this does not apply to pancreatic cancer patients. If progression happened within the first 8 weeks of immunotherapy, a second scan at least 4 weeks later may be needed to confirm it.
• People with EGFR or ALK gene changes in their cancer who have previously been treated with a targeted drug called a tyrosine kinase inhibitor.
• People who have a tumour lesion that a specialist (interventional radiologist) considers suitable for biopsy and direct injection under CT or ultrasound guidance — the tumour needs to be large enough (greater than 1 cm³ in volume) and not wrapped around or inseparable from major nerves or blood vessels. People joining the first dose level of Part 1A must have a tumour that can be felt on or just under the skin or in a superficial lymph node.
• People with at least one measurable tumour, as assessed using standard imaging criteria (called RECIST version 1.1).
• People who have had brain metastases (cancer that has spread to the brain) in the past may be eligible, provided: the brain metastases have been treated; there are no symptoms from the brain metastases; any steroid medication taken for brain metastases has been stopped for at least 7 days before joining; the brain metastases are stable on recent scans; and there is no sign of cancer spreading to the lining around the brain or spinal cord.
• People with a life expectancy of more than 3 months.
• People whose blood counts and organ function (including kidneys, liver, and bone marrow) meet the required levels as measured by blood tests — the trial site can provide the specific values required.
• People of childbearing potential who test negative for pregnancy (via urine or blood test) within 72 hours before starting treatment, and who agree to use two reliable methods of contraception, or to abstain from heterosexual activity, for the duration of the study and for 120 days after the last dose.
• Male participants who agree to use an appropriate barrier method of contraception from the first dose through to 120 days after the last dose.

Who may not be able to join:

• People who are currently pregnant or breastfeeding.
• People with serious uncontrolled medical conditions, psychiatric conditions, or significant abnormal blood test results that, in the opinion of the study doctor, could increase risks or affect the study results.
• People who have had major surgery (for example, surgery to the chest, abdomen, or pelvis) or a significant injury within the 4 weeks before starting study treatment, or who have not yet recovered from such a procedure. (Note: certain minimally invasive chest procedures may be exceptions — confirm with the trial site.)
• People with a history of significant non-infectious lung inflammation (interstitial pneumonitis), including significant radiation-related lung inflammation, that has meaningfully affected daily life or required treatment.
• People still experiencing significant side effects (grade 3 or higher) from previous cancer treatments, with the exception of hair loss.
• People currently receiving any other cancer treatment, whether approved or experimental.
• People with clinically significant, uncontrolled heart problems or a recent serious heart event within the past 6 months — this includes unstable chest pain (angina), a heart attack, a history of moderate to severe heart failure, or irregular heart rhythms not controlled by medication.
• People with an active autoimmune disease (where the immune system attacks the body's own tissues) that requires ongoing treatment to modify the disease — certain conditions such as vitiligo, Graves' disease, or psoriasis not needing systemic treatment may be exceptions.
• People with any active primary or secondary immune deficiency condition.
• People currently taking 10 mg or more per day of prednisone or an equivalent steroid medication.
• People with a history of another cancer, unless it was a non-melanoma skin cancer or certain early-stage (in situ) cancers — other prior cancers may be considered if the person achieved a complete remission at least 2 years before joining the study and no further treatment is expected to be needed during the study period.
• People with an active, serious infection currently requiring intravenous antibiotics.
• People who have previously received anti-tumour vaccines or other immune-stimulating anti-cancer agents that are not standard, approved treatments.
• People who are prisoners, involuntarily held, or compulsorily detained for treatment of a psychiatric or physical illness.
• People who still have unresolved moderate (grade 2) immune-related side effects from prior immunotherapy, except for adequately managed hormone-related side effects.
• People who previously had to permanently stop an anti-PD-1 or PD-L1 immunotherapy due to a toxic reaction.

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