We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02611960




Registration number
NCT02611960
Ethics application status
Date submitted
19/11/2015
Date registered
19/11/2015
Date last updated
23/05/2018

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
Scientific title
A Two-arm, Open-label, Randomized Phase III Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)
Secondary ID [1] 0 0
MK-3475-122
Secondary ID [2] 0 0
3475-122
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pembrolizumab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel

Experimental: Pembrolizumab - Participants receive pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle until progressive disease (PD) or unacceptable toxicity or a maximum of up to 35 cycles.

Active Comparator: Standard of Care Chemotherapy - Participants receive capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle OR gemcitabine 1250 mg/m^2 IV Days 1 and 8 of each 3-week cycle OR docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.


Other interventions: Pembrolizumab
IV infusion

Treatment: Drugs: Capecitabine
oral tablet

Treatment: Drugs: Gemcitabine
IV infusion

Treatment: Drugs: Docetaxel
IV infusion

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Overall Response Rate (ORR) per RECIST 1.1
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Number of Participants Who Experience One or More Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately 25 months
Secondary outcome [3] 0 0
Number of Participants Who Discontinue Study Drug Due to an AE
Timepoint [3] 0 0
Up to approximately 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Merck Sharp & Dohme - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Philippines
State/province [7] 0 0
Makati
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taipei
Country [9] 0 0
Thailand
State/province [9] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 standard treatment.

The primary study hypothesis is that pembrolizumab treatment prolongs progression-free
survival (PFS) and overall survival (OS) when compared to SOC treatment.
Trial website
https://clinicaltrials.gov/show/NCT02611960
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02611960