To look at the effectiveness of sacituzumab tirumotecan (MK-2870) in treating participants with treatment-refractory unresectable and/or metastatic anal/rectal cancer.
Participants must have histologically or cytologically confirmed squamous cell carcinoma of the anus or rectum that is metastatic or unresectable at the discretion of the treating investigator.
Participants must have measurable disease according to the standard RECIST version 1.1 as assessed by the local site investigator/radiology. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
Participants must have been treated with at least one, but no more than three, prior line(s) of systemic treatment, including prior cytotoxic chemotherapy and immunotherapy, for incurable advanced or metastatic SCC of the anal canal. Prior cytotoxic chemotherapy for metastatic disease is not required for participants who develop new metastatic lesions during or within 6 months of completion of chemoradiation for limited-stage disease.
Participants must be ≥18 years old.
Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history or inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular disease within 6 months before the first dose of study intervention.
Exposure to prior systemic anticancer therapy or radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis.
M.D. Anderson Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator