Phase 2 Stomach 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:

All phases — general requirements:

• People who are willing to provide tumour tissue samples as required by the study protocol
• People who have measurable or non-measurable cancer that can be tracked (note: tumour areas that have previously been treated with radiation do not count as measurable disease)
• People who have a cancer with certain specific genetic changes (such as EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS, or BRAF) must have already received and stopped responding to at least one FDA-approved targeted treatment for that genetic change
• People who are willing to sign a consent form agreeing to take part in the study
• People who are willing to return to the enrolling hospital for follow-up visits
• People who are willing to provide blood samples for research
• People who are able to care for themselves and carry out light activities (a performance score of 0 or 1 on a standard medical scale)
• People whose life expectancy is estimated to be more than 6 months
• People who have recovered from side effects of previous cancer treatments, with only mild or no remaining side effects (except for harmless effects like hair loss or skin colour changes, as judged by the treating doctor)
• People with blood test results within acceptable ranges in the weeks before joining (covering red blood cells, white blood cells, platelets, liver function, kidney function, and blood clotting — confirm specific values with the trial site)
• People who are willing to use a highly effective form of contraception from the time of joining through to 6 months after the final vaccine dose
• People who have had a tetanus vaccination in the past year, or who are willing to receive one
• People who have had a negative pregnancy test within the required timeframe before joining (applies to people who could become pregnant)

Phase I — additional requirements:

• People for whom a personalised REAL-Neo cancer vaccine has been successfully made from their tumour's genetic information

Phase II Cohort 3 (Triple-Negative Breast Cancer) — additional requirements:

• People with a confirmed diagnosis of a type of breast cancer that tests negative for oestrogen receptors, progesterone receptors, and HER2 (often called triple-negative breast cancer)
• People with stage I, II, or III breast cancer based on standard staging guidelines
• People who have residual (remaining) cancer of at least 1 cm after receiving pembrolizumab-based chemotherapy before surgery, confirmed on imaging (if surgery has not yet occurred)
• People who are willing to have surgery and provide tissue and blood samples (if surgery has not yet occurred)
• People whose remaining tumour tissue after surgery shows a certain level of cancer still present (known as residual cancer burden 2 or 3), confirmed in the surgical sample

Phase II Cohort 4 (Non-Small Cell Lung Cancer) — additional requirements:

• People with a confirmed diagnosis of non-small cell lung cancer (NSCLC)
• People whose cancer does not have certain specific genetic changes (no actionable EGFR mutations or ALK fusions)
• People with stage II or III lung cancer based on standard staging guidelines
• People with a tumour measuring at least 2 cm on imaging before surgery (or at least 2 cm of remaining disease after pre-surgery treatment, if neoadjuvant therapy was given)
• People who are willing to have surgery and provide tissue samples (if surgery has not yet occurred)
• People whose tumour tissue after surgery shows that the cancer did not completely disappear (no complete pathological response), confirmed by the pathology report
• People for whom a personalised REAL-Neo cancer vaccine has been successfully made, and who are planned to receive at least 2 more cycles of maintenance pembrolizumab

Who may not be able to join:

All phases:

• People who are pregnant
• People who are breastfeeding and unwilling to stop
• People who could become pregnant and are unwilling to use adequate contraception from joining the trial through to 6 months after the final vaccine dose
• People with serious other illnesses or conditions that, in the treating doctor's judgement, would make participation unsafe or interfere with the study
• People who have had a heart attack within the past 6 months, or who have ongoing heart failure requiring treatment for dangerous heart rhythm problems
• People who have a weakened immune system, or who are HIV-positive and currently on antiretroviral (HIV) medication

Phase I — pre-registration:

• People who have not yet recovered from side effects of previous treatment
• People with uncontrolled illness, including active infections, certain psychiatric or social situations, severe heart failure, a stroke within the past 3 months, serious heart rhythm problems, unstable chest pain, or any other condition that would prevent participation
• People currently receiving another experimental treatment for their cancer (except pembrolizumab)
• People who have previously had a serious allergic or adverse reaction to a medication called GM-CSF
• People who have had another active cancer within the past 3 years (exceptions include certain non-melanoma skin cancers and early-stage cervical cancer; people with a history of another cancer must not currently be receiving specific treatment for it)
• People who have an active autoimmune disease that has required systemic medication (such as immune-suppressing drugs or corticosteroids at higher than a low daily dose) within the past 30 days (note: hormone replacement therapies such as thyroid or insulin are not counted; certain conditions like vitiligo, Graves' disease, or psoriasis not requiring systemic treatment, or coeliac disease managed by diet, are not excluded)

Phase I — registration:

• People who have received chemotherapy, most experimental drugs, or certain targeted therapy medicines within 3 weeks before registration
• People who have received radiation therapy within 2 weeks before registration (though palliative radiation for symptom relief may be allowed if it ended more than 14 days before the first vaccine dose — confirm with trial site)
• People who have had major surgery within 4 weeks before registration
• People who have received a live vaccine within 30 days before registration
• People who had a severe (grade 3 or higher) side effect from a prior immune checkpoint inhibitor treatment, needed high-dose steroid treatment for a side effect, or had to permanently stop that treatment due to a side effect
• People with certain muscle or nerve diseases (such as inflammatory muscle disease, muscular dystrophy, ALS, or spinal muscular atrophy), or a history of a condition called rhabdomyolysis (severe muscle breakdown)
• People with an active autoimmune disease requiring ongoing steroid treatment above a low daily dose or other immune-suppressing medications
• People who have taken systemic steroids above a low daily dose or other immune-suppressing medications within the past 14 days before registration (inhaled or topical steroids and low-dose replacement steroids are generally permitted — confirm with trial site)
• People with untreated, symptomatic, or steroid-dependent spread of cancer to the brain or spinal fluid (note: people with stable, previously treated brain tumours that have shown no progression for at least 4 weeks on brain imaging may still be eligible — confirm with trial site)

Phase II — pre-screening:

• People with uncontrolled illness, including active infections, severe heart failure, serious heart rhythm problems, unstable chest pain, or conditions that would prevent participation
• People who have previously had a serious allergic or adverse reaction to GM-CSF
• People who have had another active cancer within the past 3 years (same exceptions as above apply)
• People with an active autoimmune disease that has required systemic treatment within the past 30 days (same exceptions as above apply)

Phase II — pre-registration:

• People with uncontrolled heart failure, serious heart rhythm problems, unstable chest pain, or other conditions that would prevent participation
• People who have previously had a serious allergic or adverse reaction to GM-CSF
• People who have had another active cancer within the past 3 years (same exceptions as above apply)
• People with an active autoimmune disease requiring systemic treatment within the past 30 days (same exceptions as above apply)
• People whose tumour tissue samples do not meet the required quality and quantity standards for genetic analysis (including factors such as the proportion of cancer cells in the sample, the condition of the tumour's genetic material, and the total amount of DNA and RNA available — confirm specific thresholds with trial site)

Phase II — registration:

• People whose cancer has spread to other parts of the body or has come back (metastatic disease or recurrence)
• People who have received chemotherapy, most experimental drugs, or certain targeted treatments within 3 weeks before registration (continuation of pembrolizumab as standard care is generally allowed — confirm with trial site)
• People who have received radiation within 2 weeks before registration (palliative radiation may be allowed if it ended more than 14 days before the first vaccine dose — confirm with trial site)
• People who have had major surgery within 4 weeks before registration
• People who have received a live vaccine within 30 days before registration
• People who had a severe side effect from a prior immune checkpoint inhibitor, needed high-dose steroids for a side effect, or permanently stopped that treatment due to toxicity
• People with certain muscle or nerve diseases, or a history of rhabdomyolysis
• People with an active autoimmune disease requiring ongoing high-dose steroids or immune-suppressing medications
• People who have needed systemic steroids above a low daily dose or other immune-suppressing medications within 14 days before registration (inhaled or topical steroids and low-dose replacement steroids are generally permitted — confirm with trial site)

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