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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06669572
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anorectal Cancer
  • Carcinoma, Squamous Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Pembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.
  • Lenvatinib — DRUG
    Lenvatinib will be taken once daily, with or without food, at the same time each day.

Study Details

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.

Key Dates

Start date
Jul 11, 2025
Status verified
Apr 2026
Primary completion
Mar 26, 2029
Completion
Mar 26, 2029

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Treatment consists of lenvatinib (20 mg orally once daily) in combination with pembrolizumab (200 mg IV every 3 weeks). Pembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: End of treatment up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
1-855-702-8222
Manik Amin (PRINCIPAL_INVESTIGATOR)

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By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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