Safety and Efficacy Study of Pembrolizumab (MK-3475) in Chinese Participants With Locally Advanced or Metastatic Melanoma (MK-3475-151/KEYNOTE-151)

NCT ID: NCT02821000

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-08
• Study Completion Date: 2022-11-30

Brief Summary

The purpose of this study is to determine the safety, tolerability, and objective response rate (ORR) of pembrolizumab (MK-3475) in Chinese participants with locally advanced or metastatic melanoma, with disease progression following first line chemotherapy or targeted therapy. ORR will be based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

With Amendment 6 (effective date 18-Mar-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and may be enrolled in an extension study to continue protocol-defined assessments and treatment.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab

Participants receive pembrolizumab 2 mg/kg intravenously on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

Intravenous infusion

Interventions

Pembrolizumab

Intravenous infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-3475

Eligibility Criteria

Inclusion Criteria

• Is of the Chinese descent, was born in China, and has a Chinese home address.
• Has histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy.
• Participant may not have a diagnosis of uveal or ocular melanoma.
• Overall proportion of participants with mucosa melanoma will be no more than 22%.
• Has failed the first line chemotherapy (excluding adjuvant or neoadjuvant therapy) or targeted therapy for melanoma.
• Has at least one measurable lesion as defined by RECIST 1.1 on imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]).
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Has an anticipated life expectancy of at least 3 months.
• Demonstrates adequate organ function.
• Has provided tissue for anti-programmed cell death ligand-1 (PD-L1) expression evaluation from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
• Has documented BRAF mutation status or is willing to provide a tumor tissue for BRAF genotyping.
• Females may be enrolled in the study if they are:
• Of non-childbearing potential which is defined as:

• Is ≥45 years of age and has not had menses for greater than 2 years.
• Is amenorrheic for <2 years without a hysterectomy and oophorectomy and has a follicle stimulating hormone (FSH) value in the postmenopausal range upon screening evaluation, and/or,
• Is status post hysterectomy, oophorectomy or tubal ligation.
• Female and male participants 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 treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.

Exclusion Criteria

• Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, anti-PD-L2 agents.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of study drug or who has not recovered (i.e., ≤ Grade 1 or baseline) from AEs due to agents administered more than 4 weeks earlier.
• Has had chemotherapy, targeted small molecule therapy, radiotherapy within 2 weeks prior to the first dose of study drug, or who has not recovered (i.e., ≤ Grade 1 or baseline) from AEs due to a previously administered agent.
• Has a known history of another (including unknown primary) malignancy within 5 years prior to first dose of study drug. (Exceptions include adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin, superficial bladder cancer, or cancer in situ which has undergone potentially curative therapy.)
• Is expected to require any other form of systemic or localized antineoplastic therapy while in study.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study drug.
• Has an active infection requiring intravenous systemic therapy.
• Has received a live vaccine within 4 weeks prior to the first dose of study drug.
• Has a known hypersensitivity to the components of the study drug or another mAb.
• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Is known to be Human Immunodeficiency Virus (HIV) positive.
• Has known active Hepatitis B or C.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit (Visit 1) through 120 days after the last dose of study treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Si L, Zhang X, Shu Y, Pan H, Wu D, Liu J, Lou F, Mao L, Wang X, Wen X, Gu Y, Zhu L, Lan S, Cai X, Diede SJ, Zhou Y, Ge J, Li J, Wu H, Guo J. A Phase Ib Study of Pembrolizumab as Second-Line Therapy for Chinese Patients With Advanced or Metastatic Melanoma (KEYNOTE-151). Transl Oncol. 2019 Jun;12(6):828-835. doi: 10.1016/j.tranon.2019.02.007. Epub 2019 Apr 10.

Reference Type: RESULT

PMID: 30981094 (View on PubMed)

Si L, Zhang X, Shu Y, Pan H, Wu D, Liu J, Mao L, Wang X, Wen X, Gu Y, Zhu L, Lan S, Cai X, Diede SJ, Dai H, Niu C, Li J, Guo J. Pembrolizumab in Chinese patients with advanced melanoma: 3-year follow-up of the KEYNOTE-151 study. Front Immunol. 2022 Oct 11;13:882471. doi: 10.3389/fimmu.2022.882471. eCollection 2022.

Reference Type: DERIVED

PMID: 36304457 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://merckoncologyclinicaltrials.com

Merck Oncology Clinical Trials Information

Other Identifiers

MK-3475-151

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-151

Identifier Type: OTHER

Identifier Source: secondary_id

3475-151

Identifier Type: -

Identifier Source: org_study_id