NCT06669572

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
35mo left

Started Jul 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jul 2025Mar 2029

First Submitted

Initial submission to the registry

October 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

July 11, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2029

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

October 29, 2024

Last Update Submit

April 13, 2026

Conditions

Carcinoma, Squamous CellAnorectal Cancer

Keywords

chemotherapyanorectal cancerLenvatinibPembrolizumab

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    Number of participants who achieve a complete or partial response based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

    End of treatment up to 2 years

Secondary Outcomes (4)

  • Disease control rate (DCR)

    End of treatment up to 2 years

  • Progression free survival (PFS)

    2 years after end of treatment

  • Overall survival (OS)

    2 years after end of treatment

  • Treatment Percentage

    End of treatment up to 2 years

Study Arms (1)

Treatment arm

EXPERIMENTAL

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.

Drug: PembrolizumabDrug: Lenvatinib

Interventions

PembrolizumabDRUG

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.

Treatment arm
LenvatinibDRUG

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

Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological confirmation of anorectal squamous cell carcinoma per the American Joint Committee on Cancer 8th edition. NOTE: If archived tissue is not available for diagnostic histological confirmation \[core, incisional, or excisional\], a new biopsy of a tumor lesion prior to tumor irradiation should be obtained.
  • Unresectable locally advanced or metastatic anorectal squamous cell carcinoma following progression on first line chemotherapy or chemoradiation therapy. Prior use of immunotherapy with Retifanlimab is allowed but not mandatory.
  • Prior chemoradiation therapy with either definitive intent or palliative intent is allowed.
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors 1.1 Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions within 28 days prior to registration.

You may not qualify if:

  • Has received prior therapy with an anti-PD-1, anti- PDL1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) with the exception of Retifanlimab immunotherapy.
  • Prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agents including events like pneumonitis, myocarditis, renal failure, Guillain Barre syndrome or myasthenia gravis.
  • Active autoimmune disease with ongoing treatment with chronic immunosuppressive therapy such as DMARDs .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

pembrolizumablenvatinib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Central Study Contacts

Clinical Trials Intake

CONTACT

8557028222cancerclinicaltrials@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

November 1, 2024

Study Start

July 11, 2025

Primary Completion (Estimated)

March 26, 2029

Study Completion (Estimated)

March 26, 2029

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(1)