Appendix C3
FDA-CRS Form 3.0
CLINICAL TRIAL APPLICATION FORM
CLINICAL TRIAL INFORMATION
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of
Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy
Full Title of the for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive,
Clinical Trial Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-)
Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-
B49).
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus
Abbreviated Title of Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent
the Clinical Trial Inoperable or Metastatic Breast Cancer
(MK-3475-B49/KEYNOTEB49)
Phase of Clinical □ Others
□ Phase
Trial to be □ Phase I □ Phase II Phase III (Specify)____
IV
Conducted _
☑ Table of Contents (FDA-CRS Form 1.0)
☑ Cover Letter (FDA-CRS Form 2.0)
☑ Investigational Product (IP) and Ancillary Supplies Information
☑ (FDA-CRS Form 4.0)
☑ Import License (IL) Application Form (FDA-CRS Form 5.0)
☑ Letter of Authorization (FDA-CRS Form 6.0)
☑ Proof of Payment
☑ Clinical Trial Protocol
Contents ☑ Good Clinical Practice (GCP) Certificate and Curriculum Vitae (CV)
of Principal Investigator (PI) for each Trial Site
☑ Informed Consent Form
☑ Pharmaceutical Data
☑ Good Manufacturing Practice (GMP) Certificate and/or Evidence of
GMP compliance
☑ Shipping Condition for IP and trial related materials;
☑ Labeling Materials
☑ Investigator’s Brochure
Clinical Trial MK-3475-B49 (CT identifier: NCT04895358)
Protocol Number
Protocol Version Protocol version 4.0
Number
Name/Code of Pembrolizumab plus, Protocol number: MK-3475 (CT identifier:
Investigational NCT04895358)
Product
Proposed Treatment of Chemotherapy-Candidate Hormone Receptor-Positive,
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Human Epidermal Growth Factor Receptor 2-Negative
Indication for Use (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast
Cancer
800 participants/ Patients presenting with breast neoplasms; 18
Target Population/
Characteristics of Years and older (Adult, Older Adult).
Trial Subjects
Total Number of 8
Subjects in the
Philippines
Expected Start December 17, 2021
Date
Expected End Date January 17, 2028
STUDY SITES
If the study will be conducted in more than one study site, assign a sequential number (e.g. Site1, Site2, Site 3
and so on) for each study site. Provide tabulation on a separate sheet when necessary.
Site Contact Details of PI
Name of Principal
Sequential
Study Site Investigator (Mobile No. & Email Address)
Number
Cardinal Maria Luisa
Santos A.
Site 1 Not specified
Medical Tiambeng,
Center M.D.
East Avenue Yasmin Lee-
Site 2 Medical Catalan, Not specified
Center M.D.
SPONSOR INFORMATION
Name of Sponsor Merck Sharp & Dohme (I.A.) LLC
LTO Number CDRR-NCR-S-16 / LTO-3000006624320
26/F Philamlife Tower , 8767 Paseo de Roxas, Makati City, 1226
Address
Philippines
Telephone No. (02) 8784 9500
Contact Information Mobile No. 09875462564
Is any part of the □ No
clinical trial to be
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Name of CRO: Type of Organization:
XYZ Research Organization (Phils.) ________________________
LTO No.: LTO-3000007654321
conducted by a
Attach Letter of Authorization (FDA-CRS
Contract Research
Form 6.0)
Organization?
Also attach a copy of the Signed
Agreement between
the study Sponsor and CRO
Name Ruel Vincent E. Asubar
Person responsible Designation Representative
for monitoring the
conduct and Telephone No. 4543301
progress of the
clinical trial Mobile No. 09295357559
APPLICANT STATEMENT
I/We hereby confirm that:
- The above information given is true, correct and complete, and that all relevant
information are provided
- I/We shall abide and adhere by the FDA Regulations
- I/ We shall not initiate the above-named trial until approval both from the responsible
Research Ethics Committee (REC) of the trial site/s and the FDA are obtained.
- I/ We will declare the effective date of commencement of the trial and submit necessary
reports to the to the FDA and REC concerned as soon as available
- All manufacturing and assembly operations are carried out under Good Manufacturing
Practice (GMP) conditions
- I/ We shall inform FDA of any changes to the information submitted in the application
as required
- The study will be conducted in compliance with the protocol, FDA requirements, and the
principles of Good Clinical Practice
- I/ We undertake to indemnify the Government/the Hospital against any and all actions,
claims or proceedings in respect of any injury to or death of any person whomsoever
arising out of or in connection with the carrying out of the clinical trial.
Ruel Vincent E, Asubar
Name of applicant
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Signature
Representative
Designation
XYZ Research Organization (Phils.)
Organization
4543301
Telephone No.
09295357559
Contact information Mobile No.
[email protected]
E-mail Address
April 18, 2022
Date of submission
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