Squamous Cell Carcinoma of the Anal CanalNCT06910137
An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) Together With Carboplatin and Paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)
A study testing retifanlimab in people with Squamous Cell Carcinoma of the Anal Canal, run by Incyte Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Anal Canal
- What is being tested?
- retifanlimab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- aPTT > 1.5 × ULN for participants not receiving anticoagulant therapy.
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
- Evidence of interstitial lung disease or active noninfectious pneumonitis.
- History of organ transplant, including allogeneic stem cell transplantation.
- Known active CNS metastases and/or carcinomatous meningitis, per the protocol.
- Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
- Active infections requiring systemic therapy, or IV antibiotic use up to 7 days before Cycle 1 Day 1.
- Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids).
- Participants with impaired cardiac function or clinically significant cardiac disease as assessed by the treating physician.
- Participant is pregnant or breastfeeding.
- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- retifanlimab
- Keywords
- Squamous cell carcinoma, Anal Cancer, Retifanlimab, Expanded Access Program
- Medical subject headings
- Carcinoma, Squamous Cell, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retifanlimabDrug
Also called INCMGA00012
Administered intravenous as defined in the protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Anal CanalStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910137
- Sponsor's protocol ID
- INCMGA00012-EUMA-AC-301
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) Together With Carboplatin and Paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)
- ClinicalTrials.gov ID
- NCT06910137
- Acronym / sponsor ID
- INCMGA00012-EUMA-AC-301
- Keywords
- Squamous cell carcinoma, Anal Cancer, Retifanlimab, Expanded Access Program
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (27 listed)
- 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:
- Platelets < 100 × 109/L.
- Hemoglobin < 9 g/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retifanlimabAlso: INCMGA00012Administered intravenous as defined in the protocol. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) together with carboplatin and paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing retifanlimab in people with Squamous Cell Carcinoma of the Anal Canal, run by Incyte Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (ex-US) (+800 00027423, eumedinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.