Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)

• Status: Active, not recruiting
• Trial end date: 2022-05-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of pembrolizumab (MK-3475) versus standard of care (SOC) treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of SOC treatment.

The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to SOC treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Capecitabine; Docetaxel; Gemcitabine; Pembrolizumab

Criteria

Inclusion Criteria:

• Histologically confirmed non-keratinizing differentiated NPC or undifferentiated NPC

• Metastatic disease or incurable locally recurrent disease

• Treatment with prior platinum therapy

• Tumor tissue available for programmed cell death ligand 1 (PD-L1) testing

• Measurable disease based on RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ function

• Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 180 days after the last dose of study drug

• Life expectancy of at least 3 months

Exclusion Criteria:

• Disease is suitable for local therapy administered with curative intent

• Participants previously treated in the recurrent/metastatic setting with any 1 of the 3 SOC therapies in this study (i.e., docetaxel, capecitabine, or gemcitabine) may not receive the same therapy if randomized to the SOC arm. Additionally, participants previously treated in the recurrent/metastatic setting with all 3 SOC therapies are excluded from this study.

• Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of study drug

• Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug

• Not recovered from adverse events due to therapy more than 4 weeks earlier

• Prior anti-cancer monoclonal antibody (mAb) therapy within 4 weeks prior to Study Day 1, or not recovered from adverse events

• Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1

• Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma

• Active autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, corticosteroids, or immunosuppressive agents

• Active central nervous system metastases and/or carcinomatous meningitis

• History of non-infectious pneumonitis that required steroids or current pneumonitis

• Active infection requiring systemic therapy

• Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120-180 days after the last dose of study drug according to local standard of care

• Prior therapy with an anti-programmed cell death-1 (PD-1) or anti-PD1-L1 or -L2 therapy or previously participated in a Merck pembrolizumab (MK-3475) study

• Human immunodeficiency virus (HIV) positive

• Hepatitis B or C positive

• Live vaccine within 30 days of planned start of study drug