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

NCT06669572 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma, Squamous Cell
  • Anorectal Cancer

Interventions

DRUG

Pembrolizumab

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.

DRUG

Lenvatinib

Lenvatinib will be taken once daily, with or without food, at the same time each day.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2029-03-26
Completion
2029-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06669572 on ClinicalTrials.gov