Phase 2 Study of Pembrolizumab and Lenvatinib in Anal Squamous Cell Cancer

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07680088
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Lenvatinib — DRUG
    20 mg orally daily on days 1-21
  • Pembrolizumab — DRUG
    200 mg every Day 1 Intravenous every 21 days

Study Details

The goal of this clinical trial is to see the safety and efficacy of pembrolizumab and lenvatinib in patients with anal squamous cell cancer that cannot be removed through surgery or is spread to other organs. Eligible participants should have also received some form of standard therapy previously for their advanced cancer. Participants will be required to come for a clinic visit and infusion of pembrolizumab. Lenvatinib will be taken by mouth at home based on direction provided by physicians and research team.

Key Dates

First listed
Jul 2, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2030

Study Design

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

Arms

  • Experimental: Lenvatinib + Pembrolizumab
    Lenvatinib 20 mg orally daily on days 1-21 Pembrolizumab 200 mg every Day 1 Intravenous every 21 days

Primary Outcome Measure

Objective response rate of pembrolizumab and lenvatinib combination [ Time Frame: From time of initial treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months ]

Central Contacts

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