A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) in Participants with Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites100 target enrollmentOctober 22, 2018

DrugsKEYTRUDA (pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 22, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Have histologically or cytologically confirmed melanoma
•2\. Have unresectable Stage III or Stage IV melanoma, per American Joint Committee on Cancer (AJCC) staging system version 8, not amenable to local therapy
•3\. Have the presence of at least 1 measurable lesion by CT or MRI per RECIST 1\.1 as confirmed by BICR. Cutaneous lesions and other superficial lesions are not considered measurable lesions for the purposes of this protocol, but may be considered as non\-target lesions
•4\. Participants must have progressed on treatment with an anti\-PD\-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD\-1 treatment progression is defined by meeting all of the following criteria:
•a. Received at least 2 doses of an anti\-PD\-1/L1 mAb
•b. Has demonstrated disease progression after PD\-1/L1 as defined by RECIST 1\.1\. The initial evidence of RECIST 1\.1 disease progression is to be confirmed using iRECIST by a second assessment no less than 4 weeks from the date of the first documented progressive disease, in the absence of rapid clinical progression
•c. Progressive disease has been documented within 12 weeks from the last dose of anti\-PD\-1/L1 mAb
•5\. Have submitted initial imaging
•6\. Have an ECOG performance status 0 to 1
•7\. Have provided a baseline tumor biopsy

Exclusion Criteria

•1\. 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 before the first dose of study intervention.
•2\. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
•3\. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study intervention and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases confirmed by repeat imaging, and have not required steroids for at least 14 days before study intervention.
•4\. Has ocular melanoma
•5\. Has known hypersensitivity to active substances or any of their excipients including previous clinically significant hypersensitivity reaction to treatment with another monoclonal antibody
•6\. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
•7\. Has an active infection requiring systemic therapy
•8\. Has known history of HIV (HIV 1/2 antibodies). No testing of HIV is required unless mandated by local health authority
•9\. Has known history of or is positive for hepatitis B (hepatitis B surface antigen \[HBsAg] reactive) or hepatitis C (HCV RNA \[qualitative] is detected). No testing of hepatitis B or C is required unless mandated by local health authority
•10\. Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis