A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma

NCT05273554 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2021-0274NCI-2022-02033
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical research study to learn if pembrolizumab in combination with lenvatinib can help to control pancreatic ductal adenocarcinoma.

Conditions

Tumor; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• To obtain a preliminary estimate of the ORR* of the combination of pembrolizumab and lenvatinib in patients with advanced pancreatic ductal adenocarcinoma

  through study completion, an average of 1 year

Study Arms (2)

Pembrolizumab

EXPERIMENTAL

by vein over about 30 minutes on Day 1 of each cycle.

Drug: Pembrolizumab; Drug: lenvatinib

Lenvatinib

EXPERIMENTAL

2 lenvatinib capsules at the same time by mouth every day while on study.

Drug: Pembrolizumab; Drug: lenvatinib

Interventions

Pembrolizumab DRUG

Given by IV

Also known as: KEYTRUDA®

Lenvatinib; Pembrolizumab

lenvatinib DRUG

Given by PO

Lenvatinib; Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• In order to be eligible for participation in this trial, the patient must:
• Have histologically or cytologically confirmed diagnosis of metastatic pancreatic adenocarcinoma based on pathology report
• Have received at least one prior regimen of therapy for metastatic disease. May have received an unlimited number of treatments in the neoadjuvant or adjuvant setting prior to the appearance of metastatic disease.
• Be willing and able to provide written informed consent for the trial.
• Be 18 years of age on day of signing informed consent.
• Have measurable disease based on RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Have documented objective radiographic progression on or after stopping treatment with first-line therapy.
• Note: the same image acquisition and processing parameters should be used throughout the study for a given patient.
• Be willing to provide tissue from a newly obtained core- or excisional biopsy of a tumor lesion from a metastatic site. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Patients for whom newly-obtained samples cannot be provided (e.g. inaccessible or patient-safety concern) may submit an archived specimen only upon agreement from Merck. The specimen must be from a biopsy site that would be accessible for at least one subsequent biopsy after initiation on the trial.
• Has the ability to swallow and retain oral medication.
• Has adequately controlled BP with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no change in antihypertensive medications within 1 week prior to randomization
• Have a performance status of 0 or 1 on the ECOG performance status scale within 5 days of starting study treatment.
• Have a predicted life expectancy of greater than 3 months.
• Demonstrate adequate organ function as defined in Table 2. All screening labs should be performed within 10 days of treatment initiation.
• Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib

You may not qualify if:

• Has pancreatic tumor other than adenocarcinoma, including: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma. Patients with vater-, periampullary duodenal-. or common bile duct malignancies are also excluded. Patients with mixed tumor types (adenocarcinoma plus other) may be included if a metastatic site has been documented as containing adenocarcinoma.
• Is currently receiving study therapy; or has participated in a study of an investigational agent and received study therapy, herbal/complementary oral- or IV medicine, or used an investigational device within 2 weeks of the first dose of this protocol's study treatment.
• Has a diagnosis of immunodeficiency or is receiving 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 trial treatment.
• Had a solid organ or hematologic transplant.
• 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.
• Had a diagnoss of an additional malignancy made within 1 year prior to first dose of study treatment with the exception of curatively treated basal-cell carcinoma of the skin, squamous-cell carcinoma of the skin, localized prostate cancer, and/or curatively resected in situ cervical- and/or breast cancers.
• Has presence of gastrointestinal condition, eg, malabsorption, that might affect the absorption of study drug.
• Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. The participant can receive diuretic drugs as needed per the treating physician, outside of the above-mentioned conditions.
• Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by the investigator and with radiology review.
• Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy (including dialysis), or laboratory abnormality that might confound the results of this trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient, in the opinion of the treating investigator.
• Has known psychiatric- or substance-abuse disorders that would interfere with cooperation with trial requirements.
• Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, a VEGFR2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• STRATEGIC ALLIANCE: Merck: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms; Adenocarcinoma

Interventions

pembrolizumab; lenvatinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Brandon Smaglo, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: August 31, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)