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OncoMatch/Clinical Trials/NCT06669572

Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment

Official title: A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.

Is NCT06669572 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lenvatinib for carcinoma, squamous cell.

Phase 2RecruitingUniversity of ChicagoNCT06669572Data as of Oct 2026

Treatment: Pembrolizumab · Lenvatinib — The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Targeted therapy

Lenvatinib

Cancer type

Anal Cancer

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: chemotherapy — first line

Cannot have received: anti-pd-1/pd-l1/pd-l2 or co-inhibitory t-cell receptor therapy

Exception: retifanlimab immunotherapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Chicago Medicine Comprehensive Cancer Center · Chicago, Illinois

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06669572 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-pd-1/pd-l1/pd-l2 or co-inhibitory t-cell receptor therapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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