Phase 1 Ovarian 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 have been diagnosed with one of the following cancer types: kidney, bladder, or prostate cancer; melanoma or other skin cancers; lung cancer; head and neck cancer; sarcoma or lymphoma; cancers of the digestive system (including the gut, liver, bile ducts, or pancreas); gynaecological cancers (ovarian, uterine, or cervical); or breast cancer.
• People who are currently being treated with a type of cancer immunotherapy called an immune checkpoint inhibitor (a drug that helps the immune system fight cancer).
• People who have developed moderate or severe diarrhoea and/or bowel inflammation as a side effect of their immunotherapy, with these symptoms starting within the past 45 days, and without other organ systems being affected.
• People who previously used steroid medications may still be considered, as long as the last dose was taken more than 30 days before the trial treatment, or the course lasted fewer than 7 days and ended more than one week before the trial treatment.
• People who previously used certain immune-suppressing medications (such as Infliximab or Vedolizumab) for conditions unrelated to their immunotherapy side effects may still be considered, as long as the last dose was given at least 3 months before the trial treatment.
• People who have no signs of an active gut infection at the time of starting treatment, as confirmed by stool tests or the treating doctor's assessment.
• People who have been cleared to participate by an infectious disease specialist or their treating doctor, even if some infection screening tests came back positive (for example, due to a past vaccination), provided there is no evidence of an active infection such as tuberculosis within the past 60 days.
• People who are able to understand the study information and are willing to sign a consent form.
• People who have a life expectancy of more than 6 months.

Who may not be able to join:

• People under 18 years of age.
• People who still have a confirmed gut infection after completing 5 days of antibiotic treatment.
• People with a current active flare of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or active bowel damage caused by past radiation treatment.
• People who are pregnant or breastfeeding.
• People who test positive on a pregnancy test, or who decline to take a pregnancy test, unless there is clear evidence that pregnancy is not possible (such as being post-menopausal for more than one year, or recent test results confirming no pregnancy within the past 30 days).
• People who were already on immune-suppressing medications when their immunotherapy-related diarrhoea or bowel inflammation began.
• People who have serious medical conditions that make a colonoscopy procedure high risk, as assessed by the study doctors (for example, severe heart failure, bleeding in the brain, or septic shock).
• People who develop side effects from their immunotherapy affecting organs other than the bowel at the time of starting the trial treatment.
• Stool donors who are identified as being at risk of monkeypox infection or exposure based on a screening questionnaire.

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