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Closed (no longer recruiting)Last updated: 1 February 2024

POD1UM-202: This phase II trial is assessing how effective a new intravenous therapy (INCMGA00012) is in treating patients with squamous carcinoma of the anal canal (SCAC) who have gotten worse after chemotherapyA Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy

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 patients with squamous carcinoma of the anal canal (SCAC).

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

POD1UM-202

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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