Lenvatinib and Pembrolizumab in Resectable Mucosal Melanoma

NCT04622566 | Unknown Phase 2 FDA Drug

• 1 other identifier: MK59132
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized ,single center clinical study which is designed to investigate whether combination of Pembrolizumab with Lenvatinib could improve pCR rate and consequent survival in resectable mucosal melanoma. All the eligible patients were assigned to receive Lenvatinib once a day (QD) for 6 weeks plus pembrolizumab on Day 1 of each 21-day cycle (Q3W) concurrently on days 1 and 22, followed by surgery and 18 cycles of Pembrolizumab 200mg q3w of adjuvant phase.

Conditions

Mucosal Melanoma; Neoadjuvant Treatment

Keywords

pembrolizumab; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate: defined as the percentage of subjects without alive tumor cells in the resected specimen post operation.

  To evaluate pathological complete response (pCR) rate of Pembrolizumab combined with Lenvatinib as neoadjuvant therapy for resectable mucosal melanoma.

  Approximately 10 weeks

Secondary Outcomes (3)

• 1 year RFS (recurrence-free survival) rate per RECIST1.1 as Assessed by investigator

  Approximately 1 year

• Overall survival

  Approximately 2 years

• Incidence of AEs/SAEs

  Approximately 2 years

Other Outcomes (1)

• The time from surgery completion to wound healing

  Approximately 12 weeks

Study Arms (1)

Lenvatinib and Pembrolizumab in Resectable mucosal Melanoma.

EXPERIMENTAL

Drug: Lenvatinib, Pembrolizumab

Interventions

Lenvatinib, Pembrolizumab DRUG

After enrollment, patients receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for 6 weeks; Lenvatinib 20mg orally once daily for 6 weeks. Patients conduct surgery within 1-4 weeks after the last dose of Pembrolizumab and Lenvatinib. After complete surgery, Pembrolizumab will be as adjuvant treatment for up to 15 cycles, 200mg IV on day 1 of every 21 day-cycles.

Also known as: Biological: Pembrolizumab IV infusion Other Names: MK-3475; KEYTRUDA®, Drug: Lenvatinib Oral capsule Other Names: MK-7902; E7080; LENVIMA®

Lenvatinib and Pembrolizumab in Resectable mucosal Melanoma.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Be willing and able to provide written informed consent for the trial. 2. Be a male or female subject and is 18-75 years of age on day of signing informed consent.
• \. Have histologically or cytologically confirmed resectable mucosal melanoma. Only cases where a complete surgical resection with tumour-free margins can safely be achieved, as assessed by the surgeon, are defined as resectable.
• \. Newly diagnosed melanoma without any previous anti-cancer treatment 5. Patients must be able to provide a biopsy at baseline 6. Able to swallow and retain oral medication 7. Be medically fit enough to undergo surgery as determined by the treating medical and surgical oncology team 8. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
• \. Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 1 week prior to treatment initiation.
• \. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week before treatment initiation.
• \. Males and female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication.
• \. (Female subject of childbearing potential) Have a negative urine or serum pregnancy test within 1 week prior to receiving the first dose of study medication. If the urine test is positive or borderline a serum pregnancy test will be required.

You may not qualify if:

• \. Has a known additional malignancy that is progressing or requires active treatment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• \. Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
• \. Has received any prior systemic anti-cancer treatment for melanoma 4. Has received prior lenvatinib 5. Has received prior therapy with an anti-PD-1 or anti-PD-L1 agent 6. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.
• Note: subject should be excluded if he/she received an investigational agent with anti-cancer or anti-proliferative intent within the last 12 months.
• \. Has received a live vaccine within 30 days of the first dose of study treatment.
• Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., FluMist ®) are live attenuated vaccines, and are not allowed.
• \. Has an active autoimmune disease that has required systemic treatment in 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) is not considered a form of systemic treatment.
• \. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 1 week prior to the first dose of trial treatment.
• \. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• \. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
• \. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis 13. Has an active infection requiring systemic therapy. 14. Has presence of gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
• \. Has had a major surgery within 4 weeks prior to initiation of treatment. Adequate wound healing after major surgery must be assessed clinically and have resolved completely.
• \. Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
• \. Has radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
• \. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

lenvatinib; pembrolizumab

Study Officials

• Jun Guo, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Guo, MD

CONTACT

86-10-88196317; guoj307@126.com

Lu si, MD

CONTACT

86-10-88196317; silu15_silu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Renal carcinoma and Melanoma Department in Bejing Cancer Hospital

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 10, 2020
• Study Start: December 30, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

CN (1)