Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
DrugPembrolizumab 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
DrugLenvatinib will be taken once daily, with or without food, at the same time each day.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Treatment armExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
End of treatment up to 2 yearsSecondary outcomes
1
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.
Time frame
End of treatment up to 2 years2
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.
Time frame
2 years after end of treatment3
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.
Time frame
2 years after end of treatment4
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.
Time frame
End of treatment up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov