Carcinoma, Squamous CellPhase 2NCT06669572
Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment
A Phase 2 study testing Pembrolizumab and Lenvatinib in people with Carcinoma, Squamous Cell and Anorectal Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell, Anorectal Cancer
- What is being tested?
- Pembrolizumab and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 26 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Manik Amin
About this study
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.
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
- Being tested
- Pembrolizumab, Lenvatinib
- Keywords
- chemotherapy, anorectal cancer, Lenvatinib, Pembrolizumab
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
LenvatinibDrug
Lenvatinib will be taken once daily, with or without food, at the same time each day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pembrolizumab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatment up to 2 years
Secondary outcomes (4)
Disease control rate (DCR)
To evaluate the efficacy of combination treatment of lenvatinib plus pembrolizumab, by disease control rate (DCR), in patients with unresectable locally advanced and/or metastatic anorectal squamous cell carcinoma progressed on first-line chemotherapy.
Measured: End of treatment up to 2 years
Progression free survival (PFS)
To evaluate the efficacy of combination treatment of lenvatinib plus pembrolizumab, by progression free survival (PFS), in patients with unresectable locally advanced and/or metastatic anorectal squamous cell carcinoma progressed on first-line chemotherapy.
Measured: 2 years after end of treatment
Overall survival (OS)
To evaluate the efficacy of combination treatment of lenvatinib plus pembrolizumab, overall survival (OS), in patients with unresectable locally advanced and/or metastatic anorectal squamous cell carcinoma progressed on first-line chemotherapy.
Measured: 2 years after end of treatment
Treatment Percentage
Percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.
Measured: End of treatment up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start11 Jul 2025
- Primary completion26 Mar 2029 (estimated)
- Study completion26 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669572
- Sponsor's protocol ID
- IRB24-1542
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06669572
- Acronym / sponsor ID
- IRB24-1542
- Conditions
- Carcinoma, Squamous Cell, Anorectal Cancer
- Keywords
- chemotherapy, anorectal cancer, Lenvatinib, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 26 Mar 2029 (estimated)
- Study completion
- 26 Mar 2029 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Pembrolizumab, Drug: LenvatinibTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab 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 | Treatment arm |
| LenvatinibLenvatinib will be taken once daily, with or without food, at the same time each day. | Drug | Treatment arm |
Primary outcome
Objective response rate (ORR)
Time frame: End of treatment up to 2 years
Number of participants who achieve a complete or partial response based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
4 secondary outcomes
Disease control rate (DCR)
Time frame: End of treatment up to 2 years
Progression free survival (PFS)
Time frame: 2 years after end of treatment
Overall survival (OS)
Time frame: 2 years after end of treatment
Treatment Percentage
Time frame: End of treatment up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Lenvatinib in people with Carcinoma, Squamous Cell and Anorectal Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (8557028222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: End of treatment up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.