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High Grade Fallopian Tube Serous AdenocarcinomaPhase 2NCT05114421

Pembrolizumab and Lenvatinib for the Treatment of Serous Ovarian Cancer Patients

A Phase 2 study testing Lenvatinib and Pembrolizumab in people with High Grade Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma, run by M.D. Anderson Cancer 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
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Trial summary

This pilot clinical trial studies the effect of pembrolizumab and lenvatinib in treating patients with high-grade serous ovarian cancers. 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Lenvatinib and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
9 Nov 2021to 31 Jan 2027
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female participants who are at least 18 years of age.
  • Signed written informed consent.
  • A histology confirming diagnosis of high grade serous ovarian/peritoneal/fallopian tube cancers and platinum-resistant disease as defined as disease progression on a platinum-containing agent or recurrent within 180 days of prior dose of a platinum-containing chemotherapeutic regimen will be enrolled in this study. Pathology must have been reviewed at MD Anderson.
  • A female participant is eligible to participate if at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 5 months after the last dose of study treatment.
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  • Measurable disease is present as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criterion, and there is disease present in the peritoneal cavity or retroperitoneal lymph nodes. Disease outside the peritoneal cavity is allowed as long as metastases are present within the peritoneal cavity or retroperitoneum.
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the start of treatment.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
  • Participants willing to undergo intraperitoneal port placement and scheduled peritoneal fluid and peripheral blood draws.
  • Absolute neutrophil count (ANC) >= 1500/uL (within 10 days prior to start of study treatment)
  • Platelets >= 100,000/uL (within 10 days prior to start of study treatment)
  • Hemoglobin >= 9.0 g/dL (transfusion is allowed) (within 10 days prior to start of study treatment)
  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks of the screening test. Participants may be on a stable dose of erythropoietin (>= approximately 3 months).
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 30 mL/min for participants with creatinine > 1.5 x ULN (within 10 days prior to start of study treatment)
  • Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 10 days prior to start of study treatment)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 10 days prior to start of study treatment)
  • 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 (within 10 days prior to start of study treatment)

Who cannot join

  • Is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. If a WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization that cannot be confirmed as negative, a serum pregnancy test will be required.
  • Has received prior therapy with lenvatinib
  • Has received systemic anti-cancer therapy including investigational agents (e.g. anti-vascular endothelial growth factor (VEGF) or immune checkpoint inhibitor therapy) within 4 weeks of the first planned dose of investigational therapy.
  • Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the principal investigator. If a participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Additionally, lenvatinib should not be administered for at least two weeks following major surgery and until adequate wound healing.
  • Has received prior 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 noncentral nervous system (CNS) disease.
  • 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 (e.g., FluMist) are live attenuated vaccines and are not allowed.
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  • Is currently participating in or has 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. 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.
  • 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.
  • Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers.
  • Has 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.
  • 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 allowed.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of chronic hepatitis B or hepatitis C virus infection.
  • Has a known history of active Bacillus tuberculosis (TB)
  • 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.
  • Has had an allogenic tissue/solid organ transplant.
  • Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour (h) urine collection for assessment of proteinuria. Participants with urine protein greater than or equal to 2 g/24-h will be ineligible.
  • Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association (NYHA) class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular event, or cardiac arrhythmia associated with hemodynamic instability. Note: medically controlled arrhythmia would be permitted.
  • Prolongation of corrected QT using Fridericia's formula (QTcF) interval to > 480 ms
  • Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. Subject with known deep vein thrombosis/pulmonary embolism that are under appropriate anti-coagulation treatment are eligible.
  • Has radiographic evidence of tumor encasement or invasion of a major blood vessel, or intra-tumoral cavitation.
  • Any history of hypertensive crisis with prior anti-VEGF therapy.
  • Have pre-existing >= grade 3 gastrointestinal or non-gastrointestinal fistula

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Immunomodulation of the Tumor Microenvironment in High-Grade Serous Ovarian Cancer Patients Receiving Pembrolizumab and Lenvatinib Monotherapy and Combination Therapy

This pilot clinical trial studies the effect of pembrolizumab and lenvatinib in treating patients with high-grade serous ovarian cancers. 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. Lenvatinib is an enzyme inhibitor that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may help to control the disease and provide an effective therapeutic option for cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To estimate both the individual and combined effects of pembrolizumab and lenvatinib on T-cell dysfunction and proliferation in the peritoneal tumor microenvironment (p-TME) in subjects with high-grade serous ovarian cancers with peritoneal metastasis.

SECONDARY OBJECTIVES:

  1. To estimate the objective response rate to pembrolizumab and lenvatinib combination in subjects with platinum-resistant high-grade serous ovarian cancer.

II. To estimate the individual and synergistic effects of pembrolizumab and lenvatinib on T-cell effector function, improved T cell memory establishment, and myeloid subpopulations in the p-TME.

EXPLORATORY OBJECTIVES:

  1. To profile the dynamic changes in the immune phenotypes by dissecting the cell types and functional states of various immune cell subsets in the sequential p-TME samples using single cell ribonucleic acid sequencing (scRNAseq) and investigate changes in peritoneal immune (T-cells, B cells, natural killer [NK] cells, dendritic cells, neutrophils, tumor-associated macrophages [TAMs], myeloid-derived suppressor cells [MDSCs]) and non-immune cells (fibroblasts, tumor cells) to identify cell subsets that are associated with immune resistance and therapy response.

II. To characterize T/B cell immune repertoire and their clonotypic phenotypes in a subset of responders and non-responders using single cell T-cell receptor (TCR)/B-cell receptor (BCR) sequencing (scTCR/BCRseq) simultaneously with scRNAseq.

OUTLINE: Patients are randomized to 1 of 2 arms.

COHORT A: Beginning cycle 0, patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Beginning cycle 1, patients also receive lenvatinib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

COHORT B: Beginning cycle 0, patients receive lenvatinib PO QD on days 1-21. Beginning cycle 1, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days, every 6 weeks for 1 year, then every 9 weeks thereafter. Patients with confirmed disease progression are followed every 12 weeks.

What participants receive

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

  • LenvatinibDrug

    Also called E7080, ER-203492-00, Multi-Kinase Inhibitor E7080

    Given PO

  • PembrolizumabBiological

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

    Given IV

Study groups in NCT05114421
Study groupRoleWhat they receive
Cohort A (pembrolizumab, lenvatinib)ExperimentalBeginning cycle 0, patients receive pembrolizumab IV over 30 minutes on day 1. Beginning cycle 1, patients also receive lenvatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Lenvatinib; Biological: Pembrolizumab
Cohort B (pembrolizumab, lenvatinib)ExperimentalBeginning cycle 0, patients receive lenvatinib PO QD on days 1-21. Beginning cycle 1, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Lenvatinib; Biological: Pembrolizumab

What is being measured

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

  1. Change in the proportion of CD8+ and CD4+ cells that are PD1+CD38+ at the monotherapy phase in comparison to the combination therapy phase of treatment.

    Measured: through study completion, an average of 1 year

  2. Change in the proportion of CD8+ and CD4+ cells that are Ki67+ at the monotherapy phase in comparison to the combination therapy phase of treatment.

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted10 Nov 2021
  2. Study start9 Nov 2021
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05114421
Sponsor's protocol ID
2020-1121
Other IDs
NCI-2021-09060, 2020-1121
Status last verified
Aug 2026
First submitted
31 Aug 2021
Last updated
10 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 and Pembrolizumab in people with High Grade Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma, run by M.D. Anderson Cancer 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 19 inclusion and 27 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 10 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?

Change in the proportion of CD8+ and CD4+ cells that are PD1+CD38+ at the monotherapy phase in comparison to the combination therapy phase of treatment. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT05114421.

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 10 Aug 2026.

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