An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) Together With Carboplatin and Paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

To provide retifanlimab, on a reactive basis, to adult patients with squamous carcinoma of the anal canal in combination with carboplatin and paclitaxel and who are considered ineligible for other therapeutic options including clinical trials.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to comprehend and willing to sign a written ICF for the study.

Are 18 years of age or older (or as applicable per local country requirements).

Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC.

Adequate ECOG performance status to be able to benefit from the treatment.

Disqualifiers

Has received prior PD-(L)1 directed therapy.

Participants must have recovered from previous therapies for example including but not limited to RT and CRT.

Platelets < 100 × 109/L.

Hemoglobin < 9 g/dL.

Trial design

Treatments tested in this trial

  • retifanlimab

    Drug

    Administered intravenous as defined in the protocol.

Treatment groups

No treatment groups listed

Trial outcomes

This trial has no outcomes listed.

Locations

This trial has no locations.

Sponsors and contacts

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