Pan Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

This is a Phase 2, open-label, pan tumor, continuation, rollover study that
includes ongoing studies (Parent Study) selected by BMS and enrolls
participants either being treated with nivolumab or in follow-up having
participated in a trial investigating nivolumab. This study provides an
opportunity for uninterrupted nivolumab drug supply or extended survival
follow-up. Treatment regimens offered include either nivolumab at 480 mg IV
every 4 weeks or 240 mg IV every 2 weeks per Investigator*s choice. With
nivolumab administration of 480 mg IV every 4 weeks or 240 mg IV every 2 weeks,
participant convenience will be optimized; longitudinal collection of safety
data and survival follow-up may guide future development of anti PD-1 clinical
trials.

Primary:
Long-term safety of nivolumab in participants on treatment and in follow up

Exploratory:
To follow participants who have completed therapy and are in or have completed
follow-up on a parent study investigating nivolumab or nivolumab combination
therapy for long-term efficacy (including OS).

This is a Phase 2, open-label, continuation, rollover study of nivolumab for
participants who will be provided nivolumab as monotherapy or have finished
treatment and are now in or have completed follow up on another
company-sponsored nivolumab clinical trial (Parent Study) selected by BMS. The
Parent Study has completed database lock for its primary and where applicable
secondary endpoints. This study provides an opportunity for uninterrupted
nivolumab drug supply. There is no target number of participants to be enrolled
in this study. Treatment regimens offered include either nivolumab at 480 mg IV
every 4 weeks or 240 mg IV every 2 weeks per Investigator*s choice. Safety and
tolerability information will be collected through adverse event reporting.
Adverse events will be assessed by the NCI Common Terminology Criteria for
Adverse Events (CTCAE version, 5). Participants will be contacted for overall
survival every 3 months.

Imaging assessments for this study should be performed per the local standard
of care.

Participants will continue treatment until the Investigator deems that the
participant is no longer benefiting from treatment. Additional reasons for
discontinuation from treatment may include disease progression, unacceptable
toxicity, or other criteria for discontinuation as outlined in Protocol Section
8.1.

All treated participants in the rollover study will be followed for long-term
safety for a minimum of 100 days after their last dose of nivolumab, which will
continue through survival follow-up.

nivolumab at 480 mg IV every 4 weeks or 240 mg IV every 2 weeks per
Investigator*s choice

All subjects will complete screening. Procedures will include a physical exam
including vital signs, a blood sample for safety tests and tests for hepatitis
B, hepatitis C and pregnancy.

Subjects that ended nivolumab treatment in Parent Study will be followed for
safety only. Visits may be conducted over the telephone, per email, patient
portal, or in the hospital, and will occur approximately every 3 months.

Subjects that were on ongoing nivolumab treatment in the Parent Study will
continue using nivolumab in this follow up study. The duration of treatment is
variable and depends on the subject's response to treatment. Treatment is given
in 2-4 week cycles with a visit on day 1 of each cycle. Treatment ends when the
subject no longer benefits from treatment. Additionally, subjects will complete
an end of treatment visit and day 30 and day 100 follow-up visits. Procedures
during each visit will include a physical exam including vital signs, a blood
sample for safety tests and a pregnancy test.

Subjects that end nivolumab treatment in the follow up study will continue to
be followed for safety. Visits may be conducted over the telephone, per email,
patient portal, or in the hospital, and will occur approximately every 3 months
after end of treatment.

Nivolumab is approved for the treatment of several types of cancer in multiple
regions including the United States (US, Dec-2014), the European Union (EU,
Jun-2015), and Japan (Jul-2014). Nivolumab is also being investigated in
various other types of cancer as monotherapy or in combination with other
therapies. Single-dose nivolumab monotherapy was also investigated in a Phase
1b study and a Phase I/II study of patients with sepsis who were also managed
according to established best practice care for sepsis.

The overall safety experience with nivolumab, as a monotherapy or in
combination with other therapeutics, is based on experience in approximately
20,200 subjects treated to date.

For monotherapy, the safety profile is similar across tumor types. In Phase 3
controlled studies, the safety profile of nivolumab monotherapy is acceptable
in the context of the observed clinical efficacy, and manageable using
established safety guidelines. Clinically relevant AEs typical of stimulation
of the immune system were infrequent and manageable by delaying or stopping
nivolumab treatment and timely immunosuppressive therapy or other supportive
care.

Based on data from a completed Phase 1b study and a Phase I/II study, single
doses of either 480 mg or 960 mg nivolumab did not result in unexpected safety
findings for participants with sepsis or septic shock.

In several ongoing clinical trials, the safety of nivolumab in combination with
other therapeutics such as ipilimumab, cytotoxic chemotherapy,
anti-angiogenics, and targeted therapies is being explored. Most studies are
ongoing and, as such, the safety profile of nivolumab combinations continues to
evolve. The most advanced combination under development is nivolumab +
ipilimumab, which is approved in subjects with unresectable or metastatic
melanoma (see Investigator's Brochure (IB) Appendix 2 [USPI] and Appendix 3
[SmPC]), approved in subjects with intermediate or poor risk, previously
untreated advanced RCC (see IB Appendix 2 [USPI] and Appendix 3 [SmPC]),
approved in microsatellite instability-high or mismatch repair deficient CRC
(see IB Appendix 2 [USPI], and being studied in multiple tumor types (see IB
Section 5.5.2). Results to date suggest that the safety profile of nivolumab +
ipilimumab combination therapy is consistent with the mechanisms of action of
nivolumab and ipilimumab. The nature of the AEs is similar to that observed
with either agent used as monotherapy; however, both frequency and severity of
most AEs are increased with the combination.