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Advanced Pancreatic Ductal AdenocarcinomaPhase 2NCT04887805

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

A Phase 2 study testing Lenvatinib Mesylate and Pembrolizumab in people with Advanced Pancreatic Ductal Adenocarcinoma and Stage II Pancreatic Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenvatinib Mesylate and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
21 Jul 2021to 5 Nov 2026
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

  • 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
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  • 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
  • Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks (performed within 14 days prior to day 1)
  • Absolute neutrophil count (ANC) >= 1,500/mm^3 (performed within 14 days prior to day 1)
  • Platelets >= 100,000/mm^3 (performed within 14 days prior to day 1)
  • Total serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (performed within 14 days prior to day 1)
  • Aspartate Aminotransferase =< 1.5 x ULN or =< 3 x ULN with liver metastases (performed within 14 days prior to day 1)
  • Alanine aminotransferase (ALT) =< 1.5 x ULN or =< 3 x ULN with liver metastases (performed within 14 days prior to day 1)
  • Creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 30 mL/min for participant with creatinine levels >1.5 x institutional ULN (performed within 14 days prior to day 1)
  • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (performed within 14 days prior to day 1)
  • aPTT =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (performed within 14 days prior to day 1)
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Who cannot join

  • 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
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  • 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)
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection. Note: no testing for Hepatitis B and hepatitis C is required unless mandated by local health authority
  • Has a known history of active TB (Mycobacterium tuberculosis)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
  • Has had an allogenic tissue/solid organ transplant
  • Electrolyte abnormalities that have not been corrected
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening
  • Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage
  • The degree of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy
  • Subjects having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is < 1 g/24 hours
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase II Trial of Lenvatinib-Pembrolizumab Maintenance Therapy in Patients With Advanced Unresectable Pancreatic Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the progression free survival (PFS) of lenvatinib mesylate (lenvatinib)-pembrolizumab as maintenance therapy in patients with advanced unresectable pancreatic cancer who have achieved partial response or stable disease following 1st or 2nd line therapy.

SECONDARY OBJECTIVES:

  1. To evaluate the safety and tolerability associated with the combination of lenvatinib-pembrolizumab as maintenance therapy for patients with advanced unresectable pancreatic cancer.

II. To evaluate the overall response rate (ORR), including confirmed and unconfirmed, complete and partial response and duration of response, of patients treated with lenvatinib-pembrolizumab in the subset of patients with measurable disease.

III. To evaluate if potential gains in PFS translates into an overall survival (OS) benefit for patients with pancreatic cancer being treated with lenvatinib-pembrolizumab in the maintenance setting.

EXPLORATORY OBJECTIVES:

I .To investigate whether lenvatinib-pembrolizumab induces measurable immune-related systemic changes in peripheral blood over the course of therapy by flow cytometry using T cell markers (e.g. CD4+, CD8+, PD1, TIM-3, LAG-3, TOX nuclear factor).

II. To conduct an exploratory study to identify global changes in expression of tumor-related genes using needle biopsy samples of PDA tumors obtained prior to and within one week after the 3rd cycle of pembrolizumab.

OUTLINE:

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

After completion of study treatment, patients are followed up at 30 days and then up to 1 year.

Being tested
Lenvatinib Mesylate, Pembrolizumab
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenvatinib MesylateDrug

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

    Given PO

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

Study groups in NCT04887805
Study groupRoleWhat they receive
Treatment (pembrolizumab, lenvatinib mesylate)ExperimentalPatients 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.
Receives: Drug: Lenvatinib Mesylate; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 4 months

Secondary outcomes (6)

  1. Progression-free survival

    Measured: 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

  2. Overall survival

    Measured: 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

  3. Time to treatment failure

    Measured: 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

  4. Response (partial response or complete response)

    Measured: Up to 1 year

  5. Duration of response

    Measured: Up to 1 year

  6. Incidence of adverse events

    Based on Common Terminology Criteria for Adverse Events 5.0.

    Measured: Up to 30 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start21 Jul 2021
  3. Primary completion22 Mar 2026
  4. Study completion5 Nov 2026 (estimated)

Resources

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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04887805
Sponsor's protocol ID
21092
Other IDs
NCI-2021-03222, 21092, P30CA033572
Status last verified
Aug 2026
First submitted
6 May 2021
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib Mesylate and Pembrolizumab in people with Advanced Pancreatic Ductal Adenocarcinoma and Stage II Pancreatic Cancer AJCC v8, run by City of Hope Medical Center 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 26 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: At 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887805.

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 11 Aug 2026.

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