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

NCT06910137 | Unknown

• 1 other identifier: INCMGA00012-EUMA-AC-301
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of the Anal Canal

Keywords

Squamous cell carcinoma; Anal Cancer; Retifanlimab; Expanded Access Program

Interventions

retifanlimab DRUG

Administered intravenous as defined in the protocol.

Also known as: INCMGA00012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If HIV-positive, a well controlled and stable disease and receiving antiretroviral therapy (ART/HAART) and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment.
• Willingness to avoid pregnancy or fathering children based on the criteria below.
• Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 120 days after the last dose of INCMGA00012 or placebo or through 180 days after the last dose of chemotherapeutic agents, whichever occurs later (or longer as appropriate based on country-specific requirements) and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
• Women of childbearing potential must have a negative serum pregnancy test at screening, agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty), and refrain from donating oocytes from screening through 120 days after the last dose of INCMGA00012 or placebo or through 180 days after the last dose of chemotherapeutic agents, whichever occurs later. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed. The definition of WOCBP is located in the protocol.
• Women of nonchildbearing potential are eligible as defined in the protocol.

You may not qualify if:

• 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.
• Participants with laboratory values at screening defined below:
• Hematology:
• Platelets \< 100 × 109/L.
• Hemoglobin \< 9 g/dL.
• ANC \< 1.5 x 109/L.
• Hepatic:
• ALT ˃ 2.5 x ULN or ˃ 5 x ULN for participants with liver metastases.
• AST ˃ 2.5 x ULN or ˃ 5 x ULN for participants with liver metastases.
• Bilirubin ≥ 1.5 x ULN unless conjugated bilirubin ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then direct bilirubin must be \< 40% of total bilirubin.
• Renal:
• Calculated creatinine clearance \< 50 mL/min calculated by Cockcroft-Gault equation (glomerular filtration rate can also be used in place of CrCl).
• Coagulation:
• INR or PT \> 1.5 × ULN, for participants not receiving anticoagulant therapy.

Sponsors & Collaborators

• Incyte Corporation: lead

Related Links

• An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) together with carboplatin and paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Anus Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Central Study Contacts

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 4, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01