Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
Eligible participants with locally advanced or metastatic squamous carcinoma of the anal canal, who have progressed following chemotherapy, will receive intravenous INCMGA00012 at a recommended phase II dose once every 28 days.
Conditions
This trial is treating people with squamous carcinoma of the anal canal (SCAC)
Eligibility
Inclusion
- Ability to comprehend and willingness to sign a written informed consent form.
- Confirmed diagnosis of locally advanced or metastatic SCAC.
- Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
- Must have measurable disease by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
Exclusion
- Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
- Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is > 30 Gy.
- Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
- Active autoimmune disease requiring systemic immunosuppression.
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Known active hepatitis infection.
- Active infections requiring systemic therapy.
- Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Incyte Corporation
Scientific Title
A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy
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