Phase 2 Colorectal 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 rectal adenocarcinoma (a specific type of rectal cancer), confirmed through a tissue sample analysis
• People who are 18 years of age or older
• People who are generally well enough to carry out daily activities with little to no limitation (as measured by a standard health scoring tool called ECOG, with a score of 0 or 1)
• People whose cancer is at a specific stage of spread within or around the rectum, as defined by the trial's staging criteria (confirm with trial site)
• People whose tumour is located within 5 cm of the anal opening
• People whose rectal cancer can be removed through a surgical technique called total mesorectal excision
• People who have no signs that the cancer has spread to other parts of the body
• People who have not previously had radiation therapy to the pelvic area
• People who have not previously had chemotherapy or surgery for rectal cancer
• People who do not have an active infection requiring antibiotic treatment taken by mouth or by injection
• People whose blood test results fall within the required ranges for haemoglobin, platelets, bilirubin, and liver enzymes (confirm specific values with trial site)
• People who are able to read and sign an informed consent form, or who can have the form read to them in full by an official translator if needed — a relative or a member of the clinical team may not act as translator
• Female participants of childbearing potential who have a negative pregnancy blood test within 4 weeks before starting treatment
• Female participants of childbearing potential and male participants with female partners of childbearing potential who agree to use highly effective contraception or remain abstinent from the start of treatment until at least 30 days after the last dose of Etrumadenant, 120 days after the last dose of Zimberelimab (whichever is longer), and at least 9 months after the last dose of oxaliplatin for women or 6 months for men
• People with a separate or previous cancer whose history or treatment is unlikely to affect the safety or results of this trial (confirm with trial site)

Who may not be able to join:

• People whose rectal cancer has come back after previous treatment
• People whose rectal cancer cannot be surgically removed because the tumour is attached to or fixed against nearby structures in the pelvis
• People whose cancer has reached the outer edge of the surgical margin (the radial margin)
• People whose kidney function blood test (creatinine) is above 1.5 times the upper normal limit
• People who have previously had radiation therapy to the pelvic area
• People whose heart rhythm measurement (QTc interval) is 480 milliseconds or more on an ECG (confirm with trial site)
• People who have recently taken certain medications that may interact with one of the trial drugs (Etrumadenant), including specific oral medications in the following groups (confirm specific drug names and timeframes with trial site):
  • Certain drugs that interact with a transport protein called BCRP (e.g., prazosin, rosuvastatin), taken within the past 4 weeks or 5 half-lives of the drug
  • Certain drugs that interact with a transport protein called P-gp (e.g., digoxin), taken within the past 4 weeks or 5 half-lives of the drug
  • Strong drugs that either block or trigger a liver enzyme called CYP3A4 (e.g., rifampin, clarithromycin, grapefruit juice, ketoconazole, St. John's Wort, and others), taken within a specified recent period
  • Herbal or natural remedies (use of cannabis-based products may be considered on a case-by-case basis by the treating doctor)
  • Certain drugs that interact with other specific transport proteins (BSEP, MATE1, OCT2)
• People who have a digestive condition that would prevent them from taking oral medications, such as difficulty swallowing, nausea, vomiting, or problems absorbing food
• People who have previously been treated with a therapy that targets the adenosine pathway (a specific biological signalling system)
• People who have had a bone marrow transplant from a donor or a solid organ transplant (such as a kidney or liver transplant)
• People who have an active autoimmune disease or a history of one that required treatment with immune-suppressing medication in the past 2 years — exceptions include vitiligo and childhood asthma or allergies that have fully resolved
• People with a history of a lung condition called idiopathic pulmonary fibrosis, pneumonitis, or interstitial lung disease
• People currently taking immune-suppressing medications (such as corticosteroids or similar drugs) at doses above the equivalent of 10 mg per day of prednisone, within the past 2 weeks
• People who have received a live vaccine within the past 30 days
• People who are known to have a genetic condition called DPD deficiency, which affects how certain chemotherapy drugs are broken down by the body
• People who have nerve damage in their hands or feet rated at Grade 2 or higher (a moderate or severe level)
• People who have had a severe allergic reaction to a type of therapy called chimeric or humanised antibodies or fusion proteins
• People who have had a blood clot in an artery within the past 6 months
• People who have any other medical or psychiatric condition that the treating doctor considers would make participation in the trial inappropriate
• People who have had another cancer within the past 5 years, with the exception of certain treated skin cancers (basal cell or squamous cell) or in situ cervical cancer
• People who are receiving other cancer treatments or experimental therapies at the same time as the trial treatment
• Women who are pregnant or breastfeeding, or women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the study and for up to four weeks after the study ends

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