Pembrolizumab and Lenvatinib for the Treatment of Serous Ovarian Cancer Patients

NCT05114421 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2020-1121NCI-2021-09060
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

High Grade Fallopian Tube Serous Adenocarcinoma; High Grade Ovarian Serous Adenocarcinoma; Peritoneal High Grade Serous Adenocarcinoma; Recurrent High Grade Fallopian Tube Serous Adenocarcinoma; Recurrent High Grade Ovarian Serous Adenocarcinoma; Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  through study completion, an average of 1 year

• 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.

  through study completion, an average of 1 year

Study Arms (2)

Cohort A (pembrolizumab, lenvatinib)

EXPERIMENTAL

Beginning 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.

Drug: Lenvatinib; Biological: Pembrolizumab

Cohort B (pembrolizumab, lenvatinib)

EXPERIMENTAL

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.

Drug: Lenvatinib; Biological: Pembrolizumab

Interventions

Lenvatinib DRUG

Given PO

Also known as: E7080, ER-203492-00, Multi-Kinase Inhibitor E7080

Cohort A (pembrolizumab, lenvatinib); Cohort B (pembrolizumab, lenvatinib)

Pembrolizumab BIOLOGICAL

Given IV

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

Cohort A (pembrolizumab, lenvatinib); Cohort B (pembrolizumab, lenvatinib)

Eligibility Criteria

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

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

lenvatinib; pembrolizumab

Study Officials

• Amir A Jazaeri

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: November 10, 2021
• Study Start: November 9, 2021
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)