BMS Expanded Access Program Health Care Professional Request Form
Completion Instructions:




Nivo NON Squamous NSCLC
Please complete the fields below to submit a request to the Expanded Access Program
(includes Named Patient Program and Emergency Use) for Bristol-Myers Squibb (BMS)
Medicines.
Please do not handwrite the information in this form.
Do not include the patient’s name or submit any patient-identifying information to BMS.
Before you begin completing the request form, save the EAP Request Form to your desktop by
selecting “Save As.”

The File type should be Word.document, then click “Save.” Once the file is saved to your
desktop, please complete the required fields.

An individual (unique) e-mail address is required for all individuals.
Note: Any fields marked with a red asterisk (*) are mandatory.
To submit the request:

Upon completion of the form, please submit the request as an e-mail attachment to
eaprequests@bms.com

PLEASE NOTE: You MUST include the following in the email Subject/Title line
Nivo NON SqNSCLC NPP - HCP name - Country
If this identifying information is not in the subject line of your e-mail, the processing of
the request and shipment of drug can be delayed.
Patient eligibility will be determined by Bristol-Myers Squibb in accordance with established policies and procedures. BMS’s
acceptance and processing of this application does not guarantee that access to investigational product will be provided.
Page 1 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
Nivolumab (BMS-936558) Named Patient Program Request - NON Squamous NSCLC NPP
*Date of Request (DD/MMM/YYYY):
Click here to enter a date.
*Does this patient have histologically or cytologically
documented advanced NON SQUAMOUS NSCLC (stage
IIIb or IV)?
Choose an item.
If YES, continue with this form for NON Sq NSCLC
If NO, return to the BMS Expanded Access home page
and select the form for the patient’s indication.
Patient requests submitted on the incorrect form will delay
medical review and drug shipment
*Name of Individual Completing this Form:
<enter first and last name>
*E-mail Address of Individual Completing this Form:
*Telephone Number of Individual Completing this Form
-
-
*How would you best describe yourself (select one)?
Choose an item.
Local Bristol-Myers Squibb Contact Name
If Other, please specify:
<enter first and last name>
Organization/Institution Information
*Organization/Institution Name:
<enter organization/institution name>
*Organization/Institution Address:
*Organization/Institution City, State/Province:
*Organization/Institution Postal Code/Zip Code:
* Organization/Institution Country
Note: If you have previously participated in the Named Patient
Program for the product being requested, please provide your
assigned site number. You then do not need to complete the
requested contact information below, aside from Organization/
Institution Name, along with First and Last Name of the HCP.
Updates are required if any information has changed since your last
submitted request..Also, new investigators at the same site should
provide their contact information, but after the site name or number,
the remainder of the site details do not need to be repeated
<enter address line 1>
<enter address line 2>
<insert city, state/province>
<insert postal/zip code>
<insert country>
BMS Nivo NON Sq NPP Site Number: _ _ _ _
Requesting Health Care Professional (Doctor/Treating Physician) Information
* Health Care Professional (HCP) Name:
<enter first and last name>
Title:
<enter HCP Title>
*Organization/Institution Name:
<enter organization/institution name>
*HCP Address:
<enter address line 1>
<enter address line 2>
<insert city, state/province>
<insert postal/zip code>
*HCP City, State/Province:
Page 2 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
*HCP Postal Code/Zip Code:
<insert country>
*HCP Country:
☐ Please either provide the HCP address as outlined
above or place an “X” in this box if the information is
the same as the organization/institution address
*HCP Telephone Number:
HCP Mobile Number:
*HCP E-mail Address:
Please Note: It is CRITICAL to the timely processing of the patient drug request that the section below
contain complete and accurate information.
I confirm that the “Investigational Product Shipment Information” entered here has been verified with the
Pharmacy serving my patient treatment location.
_________YES _________NO
If NO, please explain:__________________________________________________________________
This information is required for the first patient request from your site.
It is NOT required for subsequent submissions, unless there is a change in the contact information or
address
Investigational Product Shipment Information
Nivolumab (BMS-936558)
Site Name (30 Character Limit)
BMS NON Sq NPP Site Number
____
Pharmacy Contact - Name/Title
<enter first and last name>
Pharmacy Contact Email Address
Additional Pharmacy Contact - Name/Title (if available)
<enter first and last name>
Additional Pharmacy Contact Email Address
Pharmacy Shipment Address
(must be complete and accurate for receipt of overnight
shipments):
<enter address line 1>
<enter address line 2>
Street Name
Pharmacy City
Pharmacy Region (or indicate N/A)
Pharmacy Postal Code
Pharmacy Country
Pharmacy Telephone Number (include country code)
-
Page 3 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
-
Pharmacy FAX Number (include country code)
-
Additional Comments (e.g. delivery location specifics)
IVRS Contacts: Please complete the table below with the names and contact information of all site
participants who will need access to the NPP IVRS for management of the drug supply.
Incomplete information or a blank table will result in delays in site set up & drug supply processing.
This information is required for the first patient request from your site.
It is NOT required for subsequent submissions, unless there is a change in the contact information for IVRS
participant access
Role
(Inv, Pharmacist,
Nurse, Coordinator,
etc) (required)
First Name
(required)
Last Name
(required)
Email Address
(required)
Telephone #
(required)
FAX #
(optional)
Site Coordinator Information
Site Coordinator Name:
<enter first and last name>
Site Coordinator E-mail Address:
Site Coordinator Telephone Number:
Regulatory Document Coordinator Information (if different from Site Coordinator)
Regulatory Document Coordinator Name:
<enter first and last name>
Regulatory Document E-mail Address:
Regulatory Document Telephone Number:
Site Legal Information for Confidentiality Agreement and Contract Negotiations
Site Legal Contact Name:
<enter first and last name>
Site Legal E-mail Address:
Site Legal Telephone Number:
-
Patient Characteristics
*Patient Initials/Identifier (limit of 3 characters):
- -
* Disease/Indication to be Treated:
* Date of Diagnosis (MM/YYYY, if known):
MM/YYYY
*Age of Patient (Years):
Patient Month/Year of Birth (MM/YYYY): REQUIRED
MM/YYYY
Page 4 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
*Gender of Patient:
Choose an item.
Weight of Patient (kg):
Height of Patient (cm):
Date of Assessment:
Click here to enter a date.
Date of Assessment:
Click here to enter a date.
*Has the patient participated in a Bristol-Myers Squibb study (select one)? Choose an item.
If Yes, please provide Bristol-Myers Squibb protocol number, patient number and outcome, if available:
*Medical History:Provide patient medical history/current physical condition/ rationale for request (including a
detailed summary of disease):
*Patient Medications
List patient's current treatment(s), concomitant medication(s) including herbals, and outcome (if applicable) for
disease/indication for which this request is being made:
Please list one treatment per line and add additional rows (if required).
☐ Not Applicable- No current treatment
Current Medications:
*Prior Treatment(s)
List patient’s prior treatment(s), and outcome, (if applicable) for disease/indication for which this request is being
made.
Please list one treatment regimen per line and add additional rows (if required).
☐ Not Applicable- No prior treatment
Prior Treatment(s)
Start/End Dates of
Treatment(s)
Outcome/ Response Reason for
to Treatment
Discontinuation
Comments
Page 5 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
MM/YYYY - MM/YYYY
NON Sq NSCLC Patient Eligibility)
*Treatment is planned to continue as long as the patient continues to experience
benefit and tolerates therapy, as per the treating physician.
Choose an item.
*Treatment will be administered in a facility with prior experience handling
investigational products for cancer, and by a physician with prior clinical trial
experience.
Choose an item.
*There are no other comparable or satisfactory alternative therapies or available
clinical trials to treat the patient’s disease or condition and/or all currently available
therapies have been exhausted.
Choose an item.
*There is nothing unique about this patient which suggests that a clinically
meaningful benefit from the proposed treatment plan would not be expected.
Choose an item.
*There is nothing unique about this patient which suggests that there would be an
unreasonable risk posed by the administration of nivolumab IV - 3 mg/kg every 2
weeks.
Choose an item.
*Does the patient have documented disease progression or recurrence after at
least1 line of systemic therapy for advanced or metastatic disease (radiation
therapy, surgical resection, or definitive chemoradiation for locally advanced
disease)
*What is the patient's ECOG performance status?
Choose an item.
*Date of Assessment for ECOG Performance Status (DD/MMM/YYYY):
Click here to enter a date.
*Does the patient have a life expectancy of > 6 weeks?
Choose an item.
Choose an item.
Page 6 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
*Does the patient have carcinomatous meningitis?
Choose an item.
*Does the patient have brain metastases?
Choose an item.
*If YES (patient has brain metastases), is the patient treated and stable for at least
two weeks?
Choose an item.
*If YES (patient has brain metastases), is the patient under treatment with systemic
steroids (>10 mg/day prednisone equivalents) for brain metastases?
Choose an item.
*Does the patient have liver metastases?
Choose an item.
*Does the patient have any known history of testing positive for HIV or known
AIDS?
Choose an item.
*Does the patient have interstitial lung disease that is symptomatic or may interfere
with the detection or management of suspected drug-related pulmonary toxicity?
Choose an item.
*Have all toxicities attributed to prior anti-cancer therapy other than alopecia or
fatigue resolved to Grade 1 (NCI CTCAE version 4) or baseline?
Choose an item.
*Has the patient received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, antiCD137, or anti-CTLA-4 antibody(including ipilimumab or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways)?
Choose an item.
*Has the patient received prior treatment in any nivolumab trial including prior
treatment on either arms of nivolumab study CA209-104?
Choose an item.
*Does the patient require ongoing treatment with more than 10 mg of prednisone
(or steroid equivalent,excluding inhaled or topical steroids) daily?
Choose an item.
*Has the patient received prior chemotherapy, TKI or immunotherapy (tumor
vaccine, cytokine or growth factor to control the cancer)?
Choose an item.
If Yes, will the prior chemotherapy, TKI or immunotherapy be completed at least 2
weeks prior to the anticipated date of first treatment with nivolumab?
Choose an item.
*Has the patient received prior thoracic radiotherapy or radiosurgery?
Choose an item.
If Yes, will the prior radiotherapy or radiosurgery treatment be completed at least 2
weeks prior to the anticipated date of first treatment with nivolumab?
Choose an item.
*Does the patient have any auto-immune disease or related disease (except type 1
diabetes mellitus, hypothyroidism only requiring hormone replacement, skin
disorders)?
*If YES, is the patient under treatment with immunosuppressive dose of systemic
steroids (>10 mg/day prednisone equivalents)?
Choose an item.
Choose an item.
Page 7 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
Laboratory Assessments
(most recent)
REQUIRED
Value
Units
Range
*White blood cell count
*Neutrophils
*Platelets
*Hemoglobin
*Serum Creatinine
*AST
*ALT
Date of
Assessment
(DD/MMM/YYYY)
Not Done
Click here to
enter a date.
Click here to
enter a date.
Click here to
enter a date.
Click here to
enter a date.
Click here to
enter a date.
Click here to
enter a date.
Click here to
enter a date.
☐
☐
☐
☐
☐
☐
☐
Recommended laboratory values are:
WBC ≥ 2000/μL
Neutrophils ≥1500/μL
Platelets ≥ 100 x 103/μL
Hemoglobin ≥ 9.0 g/dL (patient may be transfused)
Serum Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) > 40mL/minute (using Cockcroft Gault formula)
AST:  3 X ULN
ALT:  3 X ULN
Total Bilirubin  1.5 x ULN (except patients with Gilbert’s Syndrome, who must have a total bilirubin < 3.0 mg/dL)
Comments
Please utilize this space to provide any additional comments regarding this expanded access request (optional):
IMPORTANT: Submission Instructions below:
To submit the request:

Upon completion of the form, please submit the request as an e-mail attachment to
eaprequests@bms.com

PLEASE NOTE: You MUST include the following in the email Subject/Title line
Nivo NON SqNSCLC NPP - HCP name - Country
If this identifying information is not in the subject line of your e-mail, the processing of
the request and shipment of drug can be delayed.
Page 8 of 9
Version Date: 08-June-2015
BMS Expanded Access Program Health Care Professional Request Form
Patient eligibility will be determined by Bristol-Myers Squibb in accordance with established policies and
procedures. Bristol Myers Squibb’s acceptance and processing of this application does not guarantee that access
to investigational product will be provided.
Page 9 of 9
Version Date: 08-June-2015