Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer

NCT04887805 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 21092NCI-2021-03222P30CA033572
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the effects of lenvatinib and pembrolizumab maintenance therapy in treating patients with pancreatic cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib and pembrolizumab may be effective as a maintenance therapy in patients with pancreatic cancer.

Conditions

Advanced Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression and response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and immune-modified (i)RECIST.

  At 4 months

Secondary Outcomes (6)

• Progression-free survival

  Time to disease progression/ relapse or death as a result of any cause from start of lenvatinib-pembrolizumab therapy (patients censored at last contact if no progression/relapse or death), assessed up to 1 year

• Overall survival

  Time to death as a result of any cause from start of lenvatinib-pembrolizumab therapy (patients censored at last contact if no death), assessed, up to 1 year

• Time to treatment failure

  Time to treatment termination for any reason (progression, toxicity, death, patient preference) from start of lenvatinib-pembrolizumab therapy (patients still on treatment will be censored at last contact), up to 1 year

• Response (partial response or complete response)

  Up to 1 year

• Duration of response

  Up to 1 year

Study Arms (1)

Treatment (pembrolizumab, lenvatinib mesylate)

EXPERIMENTAL

Patients receive pembrolizumab IV over 30 minutes on day 1 and lenvatinib mesylate PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Lenvatinib Mesylate; Biological: Pembrolizumab

Interventions

Lenvatinib Mesylate DRUG

Given PO

Also known as: 4-[3-Chloro-4-(N''-cyclopropylureido)phenoxy]7-methoxyquinoline-6-carboxamide Mesylate, E7080, Lenvima, Multi-Kinase Inhibitor E7080

Treatment (pembrolizumab, lenvatinib mesylate)

Pembrolizumab BIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (pembrolizumab, lenvatinib mesylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent by the participant
• Willingness to provide tissue and blood samples for correlative studies
• Age: \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
• Must have a confirmed histologic or cytologic diagnosis of advanced unresectable pancreatic ductal adenocarcinoma (PDA)
• Must have received at least 16 weeks of 1st or 2nd line therapy and achieved partial response or stable disease (by computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) with no signs of progression within 30 days before start of treatment
• Last chemotherapy treatment must be within 30 days prior to start of treatment
• No prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
• Measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Participants must have recovered from all adverse events (AEs) due to previous therapies to =\< grade 1 or baseline, with the following exception: participants with =\< grade 2 neuropathy are eligible
• Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
• A male participant must agree to use a contraception of this protocol during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• Females of child-bearing potential must be willing to use effective contraception during study and for 30 days after the last dose

You may not qualify if:

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
• Dietary/herbal supplements (cannabidiol \[CBD\] allowed)
• Other investigational products
• Current or planned se of agents contraindicated for use with strong CYP3A4 inducers
• Strong inhibitors or inducers of CYP3A
• Medications with a known potential to prolong the QT/corrected QT (QTc) interval
• Issues with tolerating oral medication (e.g. inability to swallow pills, malabsorption issues, ongoing nausea or vomiting during screening)
• Uncontrolled blood pressure (systolic blood pressure \[BP\] \> 140 mmHg or diastolic BP \> 90 mmHg) in spite of an optimized regimen of antihypertensive medication
• Women who are or are planning to become pregnant or breastfeed
• Known allergy to any of the components within the study agents and/or their excipients
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years
• Participants must not have received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease
• Participants must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
• Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
• Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g. recovery from major surgery, completion of treatment for severe infection)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

lenvatinib; pembrolizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Vincent Chung

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

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: May 6, 2021
• First Posted: May 14, 2021
• Study Start: July 21, 2021
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): November 5, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)