BMS Expanded Access Program Health Care Professional Request Form

Completion Instructions:

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.

Submission Instructions:

Upon completion of the request, please submit form as an e-mail attachment to eaprequests@bms.com

Please include the name of the BMS product for which this request is being submitted in the subject line of your e-mail.

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.

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BMS Expanded Access Program Health Care Professional Request Form

Nivolumab (BMS-936558) Named Patient Program Request (Pediatrics)

*Date of Request (DD/MMM/YYYY): Click here to enter a date.*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.

If Other, please specify:      Local Bristol-Myers Squibb Contact Name <enter first and last name>Organization/Institution Information*Organization/Institution Name: <enter organization/institution name>*Organization/Institution Address: <enter address line 1>

<enter address line 2><insert city, state/province><insert postal/zip code><insert country>

Site Number:      

*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, unless contact information has changed since your last submitted request.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><insert 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 City, State/Province:*HCP Postal Code/Zip Code:*HCP Country:

*HCP Telephone Number:      HCP Mobile Number:      *HCP E-mail Address:      Investigational Product Shipment InformationPharmacy Contact Name: <enter first and last name>Function (i.e. nurse, pharmacist, etc.):      Pharmacy Address: <enter address line 1>

<enter address line 2><insert city, state/province><insert postal/zip code><insert country>

Pharmacy City, State/Province:Pharmacy Postal Code/Zip Code:Pharmacy Country:Pharmacy Telephone Number:      -     -     Pharmacy Fax Number:      -     -     Pharmacy E-mail Address:      

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BMS Expanded Access Program Health Care Professional Request Form

Site Coordinator InformationSite 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 NegotiationsSite 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:      * Histology (include tumor genetics):* Date of Diagnosis (MM/YYYY, if known): MM/YYYY *Age of Patient (Years):      Patient Month/Year of Birth (MM/YYYY): MM/YYYY *Gender of Patient: Choose an item.Weight of Patient (kg):       Date of Assessment: Click here to enter a date.Height of Patient (cm):       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:      

*Provide patient medical history/current physical condition/ rationale for request including any diagnostic biomarker or molecular characterization.      

*Patient MedicationsList 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:                                                  

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BMS Expanded Access Program Health Care Professional Request Form

*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 to Treatment

Reason for Discontinuation

Comments

      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                        MM/YYYY - MM/YYYY                        MM/YYYY - MM/YYYY                  *Proposed Treatment PlanPlease include product(s), including the BMS product for which this request is being made, along with dose, route, planned duration. List one product per line.

Product Dose Route Planned Duration Comments                                                                                                                                                 

Insert Monitoring Procedures and Modifications to Dose (optional):      

*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 to treat the patient’s disease or condition and/or all currently available therapies have been exhausted.

Choose an item.

*Please provide rationale for why the patient would not be a good candidate for available therapies that have

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BMS Expanded Access Program Health Care Professional Request Form

not previously been used:      

*Please provide rationale for why the patient cannot participate in a clinical trial:      

*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 proposed treatment plan.

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.

*Has the patient recovered from any clinically significant toxicity experienced during prior treatment?

Choose an item.

*Has prior treatment with an anti-CTLA-4 agent been discontinued or interrupted due to an Immune-Related Adverse Event (irAE)?

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)?

Choose an item.

*If YES, is the patient under treatment with immunosuppressive dose of systemic steroids (>10 mg/day prednisone equivalents)?

Choose an item.

*Does the patient have any known infection with HIV, Hepatitis B or Hepatitis C? Choose an item.

*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 liver metastases? Choose an item.

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BMS Expanded Access Program Health Care Professional Request Form

Laboratory Assessments (most recent)

Value Units Range Date of Assessment

(DD/MMM/YYYY)

Not Done

*White blood cell count                   Click here to enter a date.

☐

*ANC                   Click here to enter a date.

☐

*Platelets                   Click here to enter a date.

☐

*Hemoglobin                   Click here to enter a date.

☐

*Serum Creatinine                   Click here to enter a date.

☐

*ALT                   Click here to enter a date.

☐

*AST                   Click here to enter a date.

☐

*Total bilirubin                   Click here to enter a date.

☐

Recommended laboratory values are:WBC ≥ 2000/μLANC ≥1000/μLPlatelets ≥ 75 x 103/μLHemoglobin ≥ 9 g/dL (patient may be transfused)Creatinine ≤ 2 x ULN

AST/ALT:- £ 2.5 x ULN for patients without liver metastases- £ 5 x ULN for patients with liver metastases.

Bilirubin £ 2 x ULN (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL)

Comments

Please utilize this space to provide any additional comments regarding this expanded access request (optional):      

Submission Instructions:

Upon completion of the request, please submit form as an e-mail attachment to eaprequests@bms.com

Please include the name of the BMS product for which this request is being submitted in the subject line of your e-mail.

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.

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