BMS INFORMED CONSENT FORM (ICF) FOR EARLY ACCESS TO MEDICINE
(NIVOLUMAB, SQUAMOUS NSCLC)
Protocol Number:
EAMS 15105/0002 / CA 209-439
Program Title:
EARLY ACCESS TO MEDICINE – NIVOLUMAB – FOR
SQUMAOUS NSCLC
Language:
English
Program Doctor Identification
Program Doctor full name: ___________________________________________
Address: ________________________________________________________________________
Telephone or other contact details: ____________________________________________________
1)
Participation
You are being asked to participate in an Early Access to Medicines Scheme (EAMS). Your eligibility
to participate in this program is decided based on specific eligibility criteria which your doctor will
have considered prior to obtaining your consent. Before you can take part in this program, however, it
is important that you understand what this program involves. Please read this information carefully
and ask any questions that you might have.
2)
Purpose of the Program
The purpose of this program is to provide patients with squamous Non Small Cell Lung Cancer
(NSCLC) access to nivolumab.
Nivolumab is an antibody (a type of human protein) that is being tested in clinical trials to see if it will
allow the body’s immune system to work against tumor cells. . An investigational drug is one that is
not approved by the European Medicines Agency (EMA) and is being studied and developed.
3)
Approximate Number of Participants and the Expected Duration of Your
Participation in the Program
The number of patients in this program will vary and will depend on the number of requests received
from UK hospitals.
Even though you may meet all the criteria for participation, it is possible that you will not be enrolled
in this program.
If you are enrolled, the duration of your participation will depend on your response to treatment, but
could be up to the time that the drug becomes commercially available.
At the time of a regulatory decision regarding nivolumab (BMS-936558) by the health authority in the
UK, no new patients will be permitted to sign an informed consent, and enrollment in the program will
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stop. Patients who are currently enrolled and receiving treatment will be required to switch to the
commercially available product. Patients who do not have access to commercially available product
for valid reasons will continue on program drug. More information will be given to you and your
program doctor at this time.
Program Treatments
4)
Nivolumab is administered by intravenous (IV) infusion, meaning the drug is a solution given through
a needle inserted into a vein. The infusion usually takes about 1 hour (60 minutes). An infusion pump
will be used to ensure the correct amount of medicine is given over the proper amount of time.
Upon entry into the program, you will receive 3 mg/kg of nivolumab every 2 weeks.
You will receive your first dose of nivolumab solution at Day 1. You may receive additional doses of
nivolumab every 2 weeks thereafter, depending on your response to the medicine.
Program Procedures
5)
For further information about the procedures in the program, please refer to the document ‘Early
Access to Medicines Scheme - Treatment Protocol Information for patients’
The period between each treatment with the program medication is called a cycle. A cycle is defined
as 2 weeks (14 days) in this program.
You will be treated with 3 mg/kg of nivolumab IV. Nivolumab will be given to you as a 60-minute
intravenous infusion on Day 1 and every 2 weeks (14 days) after that day.
At each visit that you receive program medication, you will also receive a brief physical exam, blood
tests, and assessment of side effects you may be having.
If you experience any changes in your body or develop any new or worsening side effects during or
after the infusion, you should inform the program doctor or nurse immediately.
If you experience side effects, you may be asked to return to the office more frequently (for example,
every 1-2 weeks) until the side effects get better. You may be asked to stop taking the program
drugs.
It is possible that you will be required to stop program treatment earlier than scheduled if program
treatments are not working as expected or if you have unacceptable side effects from program
treatment. Your doctor will inform you if this occurs.
Your Responsibilities
6)
During the treatment period, you will be asked to return to your doctor’s office or clinic as outlined
above.
At each visit:

You will be asked to take the program drugs as instructed.
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(NIVOLUMAB, SQUAMOUS NSCLC)

You will be asked how you feel and if you had any possible side effects. Your doctor may
prescribe medications to help control some of the side effects. Most side effects will decrease
once you finish taking the program drugs.

Tell the program doctor about all medications you are taking including prescriptions, herbal
supplements, and over-the-counter medications since other medications can change how the
program drug works.

Discuss any medication (prescription or over the counter) that you wish to start taking with
your program doctor before you start taking it. Certain medications cannot be taken while you
are in this program. Your program doctor will explain what these medications are.

Tell the program doctor about any changes in your health

Tell your program doctor about any medical treatments that you plan to receive during the
program (such as elective surgery or radiation).

Tell your program doctor or program staff if you change your address, telephone number, or
other contact information
If you have any questions or concerns about the medications used in this program, you can contact
your doctor or a member of your doctor’s staff at any time.
You must always carry with you the Patient Alert Card that you have been given.
7)
Risks / Possible Adverse Drug Reactions
For further information, please refer to the document ‘Early Access to Medicines Scheme - Treatment
Protocol: Information for Patients’.
8)
Risks to Reproduction, Unborn Babies and Nursing Infants
8A. General Statement
You must not be pregnant or breastfeeding, and you should not become pregnant or breastfeed
while you are taking the program treatments. Females should not breastfeed while receiving
nivolumab and up to 18 weeks from the last dose of nivolumab. You must use an adequate
method(s) to avoid pregnancy for the duration of this program and for up to 23 weeks after the
last dose of program drug. Male patients who are sexually active with a woman of child bearing
potential should also use an adequate method(s) of birth control to avoid pregnancy in their
partner for up to 31 weeks after the last dose of program drug. You should immediately contact
your program doctor if there is a change in your method to avoid pregnancy or if you start any
prescription drug or other medication (including over-the-counter drugs and herbal supplements)
not prescribed by the program doctor
8B. Unforeseeable Risks
There may be unknown risks to you, your unborn baby, or nursing infant if you are or become
pregnant during this program or are breastfeeding during this program.
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8C. Laboratory & Animal Reproductive Toxicology Findings
While laboratory and animal studies have been conducted to determine possible risks, the results
do not necessarily show what will happen when the drug is used in humans.
No studies have been conducted to determine if nivolumab causes damage to genetic material
(DNA). Because nivolumab is an antibody, the risk of damage to DNA is believed to be low.
Laboratory and animal studies have not been conducted using nivolumab to determine if
nivolumab may cause cancer.
One program in monkeys has been conducted to evaluate the effects of nivolumab on pregnancy.
The preliminary findings revealed an increase in late stage pregnancy loss as well as deaths in
premature infants. These animal program findings suggest a potential risk to human pregnancy if
there is continued treatment with nivolumab during pregnancy. These abnormal findings [eg, late
stage pregnancy loss in monkeys] occurred at doses that are 9 times greater than the human
nivolumab dose of 3 mg/kg every 2 weeks used in this clinical trial.
8D. Human Pregnancy Outcomes
The use of nivolumab in pregnant women has not been formally studied in clinical studies.
One case has been identified of a nivolumab treated male patient with a female partner who
became pregnant. The pregnancy was uneventful, and at birth, the infant was slightly
underweight.
8E. Findings with Similar Drugs in the Class
There is no data/information for similar drugs in this class that may be under evaluation in other
clinical trials.
8F. Significant Findings with Comparator Drugs
Not applicable.
8G. Use of a Program-Prohibited Contraceptive Method
Your program doctor will discuss prohibited and acceptable birth control methods for use during
your participation in this program.
Any birth control method used must be highly effective with a failure rate less than 1% per year
and must be discussed with your doctor if it is started during the course of the program.
At a minimum, patients must agree to the use of 2 methods of contraception, with one method
being highly effective and the other method being either highly effective or less effective as listed
below:
HIGHLY EFFECTIVE METHODS OF CONTRACEPTION
•
Male condoms with spermicide
•
Hormonal methods of contraception including combined oral contraceptive pills, vaginal
ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena® by WOCBP
patient or male patient’s WOCBP partner. Female partners of male patients participating in
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the program may use hormone-based contraceptives as one of the acceptable methods of
contraception since they will not be receiving program drug.
•
Nonhormonal IUDs, such as ParaGard®
•
Tubal ligation
•
Vasectomy
•
Complete abstinence
NOTE: Complete abstinence is defined as complete avoidance of heterosexual intercourse
and is an acceptable form of contraception for all program drugs. Patients who choose
complete abstinence are not required to use a second method of contraception, but female
patients must continue to have pregnancy tests. Acceptable alternate methods of highly
effective contraception must be discussed in the event that the patient chooses to forego
complete abstinence.
LESS EFFECTIVE METHODS OF CONTRACEPTION
•
Diaphragm with spermicide
•
Cervical cap with spermicide
•
Vaginal sponge
•
Male condom without spermicide
•
Progestin only pills by WOCBP patient or male patient’s WOCBP partner
•
Female condom
NOTE: A male and female condom must not be used together.
You should notify your program doctor if your method of contraception changes during the course
of this program.
8H. Requirements for Pregnancy Testing
If you are a woman of childbearing potential, you will have a pregnancy test within 24 hours of
your first dose of program medication, and then every 4 weeks while receiving the program drug,
and every 4 weeks or more frequently if required by the local standard of care for 23 weeks
following the end of treatment or early discontinuation of program drug. Pregnancy testing may be
performed at home if an in-office visit is otherwise not required. Telephone contacts are required
to obtain results for all patients who perform pregnancy testing at home after they have stopped
program drug treatment. Any positive results must be confirmed by serum pregnancy testing at
the program clinic site.
8I. Occurrence of Pregnancy or Suspected Pregnancy
If you become pregnant, suspect pregnancy, missed your period or it is late, or have a change in
your usual menstrual cycle (eg, heavier bleeding during your period or bleeding between
periods), you should immediately contact your program doctor.
8J. Discontinuation from the Program
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Should you become pregnant during this program, you will immediately have the program
medication permanently discontinued and be referred for obstetric care. You will continue to be
followed for any side effects or potential benefits of the program treatment, provided it is safe for
you and your unborn baby to do so. Your doctor will discuss this with you, as well as options for
additional appropriate care for your cancer. Bristol-Myers Squibb has not set aside any funds to
pay for any aspects of obstetric, child or related care and does not plan to pay for them.
8K. Pregnancy Reporting
In case of a pregnancy, your pregnancy and its outcome will be reported to the Bristol-Myers
Squibb.
8L. Information for Men with Partners of Childbearing Potential
Most program drugs do not pose a risk to a woman who becomes pregnant while her male
partner is a program patient.
You are asked to inform your program doctor if your partner becomes pregnant while you are
enrolled in this program. You and your partner will be asked to provide information about the
pregnancy outcome. Bristol-Myers Squibb has not set aside any funds to pay for any aspects of
obstetric, child or related care and does not plan to pay for them.
8K. Complete Abstinence
Complete abstinence is defined as the complete avoidance of heterosexual intercourse.
Complete abstinence is an acceptable form of contraception and must be used throughout the
duration of program and for the duration of time as specified under Section 8A. It is not necessary
to use a second method of contraception when abstinence is elected. Women of child bearing
potential who choose complete abstinence must continue to have pregnancy tests as specified in
Section 8H.
9)
Benefits
It is not possible to predict whether or not you will receive any personal benefit as a result of the
treatment given in this program.
Nivolumab may or may not lead to improvement of your Squamous NSCLC.
10) Alternative Treatment
Your doctor can provide detailed information about your cancer and the benefits of other treatments
that are available to you in the country where you live. You are encouraged to discuss treatment
options with your doctor.
11)
Compensation for Injury
If you are injured during your participation in this program, you should contact the program doctor as
soon as possible in person or at the telephone number listed on page 1 of this consent form. Medical
care may be obtained in the same way you would ordinarily obtain other medical treatment.
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A program-related injury is a physical injury that is directly caused by the program drug given as
described in the program guidance document or by medical procedures that are required by the
program and that are not standard of care.
A program-related injury does not include injuries directly caused by any of the following:

The natural course of your underlying disease or medical condition

Not following the instructions provided in this consent form or by program staff
Bristol-Myers Squibb shall not provide any compensation for any injuries related to this named
patient program.
12)
Any Prorated Payment
No compensation will be provided for your participation in this program.
13)
Any Anticipated Expenses
The NHS Trust that is taking part in this program will cover the costs of your care. This includes
routine laboratory blood tests, x-rays, MRIs, CT scans, and routine medical care. If you have private
medical insurance, you should check with the insurance provider before agreeing to take part in this
program to ensure that participating in this program will not affect your medical insurance coverage.
You and/or your treating NHS Trust will not be charged for the cost of nivolumab.
Bristol-Myers Squibb is providing nivolumab free of charge.
14)
Voluntary Participation / Discontinuation of Treatment or Withdrawal of Consent
Your participation in this program is entirely voluntary. It is up to you to decide to take part or not. If
you do decide to take part, you are free to discontinue treatment or withdraw consent from the
program at any time without giving a reason. This will not affect your future medical care in any way.
Any information collected before you withdraw will be kept and used to complete the program.
Bristol-Myers Squibb may terminate the program at any time.
15)
Program Sponsor
Your doctor and/or the institution where you will be receiving the program drug will be the sponsor of
this program.
16)
Confidentiality, Collection and Use of Program Data
16A. Collection of Program Data
Your program doctor and program staff will collect information about you which is relevant to this
program, specifically, information about your age, gender, condition for which the product is being
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used for and details of the initial biopsy which was taken at diagnosis, the dose of nivolumab to
be given and how many doses are received, underlying co-morbidities, and other medications
you are also taking. This collected information about you is called “Data” in this document.
16B. Confidentiality and use of Program Data
Your Data will be used within this program and will be shared with the Scientific Opinion Holder
Bristol-Myers Squibb Pharmaceutical Limited, for demographics reports to the MHRA.
You do have the right to access, rectify and object to processing of you Data in accordance
with the UK Data Protection Act (1988) by contacting your program doctor.
17)
Questions/Information




If you or your representative(s) have any questions regarding this program or in case of
program-related injuries, you should contact your program doctor at the telephone number
given on page one of this form.
If you or your representative(s) have any questions regarding your patient rights as they relate
to this program, you should contact your study doctor
If you seek emergency care or are admitted to the hospital, please inform the treating doctor
that you are receiving treatment with an investigational drug and show them your Patient
Alert Card
If any new information becomes available during the course of this program that may change
your willingness to participate, you will be informed.
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18) SIGNATURE




I have read and understand the information presented in this Informed Consent Form. I have
been given the opportunity to ask questions and all my questions have been answered.
I shall receive a signed and dated copy of this Informed Consent Form.
Please tick one of the boxes below:
 I agree that the program doctor may tell my personal doctor that I am taking part in this
program.
 I do not want the program doctor to tell my personal doctor that I am taking part in this
program.
I FREELY ACCEPT TO PARTICIPATE IN THIS PROGRAM
To be signed simultaneously, (i.e. on same date), by all parties:
__________________________
____________________
_______________________________
Print Name of Patient
Date (to be entered by
Patient)
Signature
____________________________
____________________
_______________________________
Print Name of person obtaining the
consent
Date
Signature
Distribution: original for Program Doctor, signed copy to Patient
For programs that may include special populations (eg, mentally incapacitated, illiterate persons) the following
additional signature lines should be provided as appropriate to the patient population.
If the participant (or, if applicable, the legally acceptable representative) is unable to read the ICF, then the
signature of an impartial witness is needed. An impartial witness is a person who is independent of the program
and who is not influenced by the program staff or people involved with the program. The impartial witness must
attend the entire informed consent process and read the informed consent document and any other written
information.
The information in this informed consent document was read to the patient or his/her legally acceptable
representative. I believe he/she understands what was read and explained and is freely agreeing to participate
in the program. The patient has signed or made his/her mark on the signature line above.
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Name of Impartial Witness
Date
(to be entered by witness)
Signature
For situations in which consent of an adult patient cannot be obtained (<eg, emergency situations, dementia>),
the signature of a legally acceptable representative is required:
Name of <patient’s> legally
acceptable representative
____________________________
Date
(to be entered by
<patient’s> legally
acceptable representative
Signature
State relationship to the patient
At any given time an incapacitated individual may explicitly refuse to participate in or request to be withdrawn
from the program. The program doctor must respect the request.
If protocol provides for interim signatory when legally acceptable representative is not immediately available,
refer to ICH 4.8.15 and provide additional signatory text box, with the following text below it:
Where possible, the patient will be informed as soon as possible and his/her consent will be requested for the
continuation of the program.
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