An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/24/2018
Start Date:January 5, 2015
End Date:November 4, 2022

Use our guide to learn which trials are right for you!

A Multi-Center Phase 2 Open-Label Study to Evaluate Safety and Efficacy in Subjects With Melanoma Metastatic to the Brain Treated With Nivolumab in Combination With Ipilimumab Followed by Nivolumab Monotherapy

This is a study of Nivolumab combined with Ipilimumab followed by Nivolumab by itself for the
treatment of patients with Melanoma that has spread to the brain. Patients with
histologically confirmed Malignant Melanoma and asymptomatic brain metastases are eligible
for the study.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

1. Target Population

1. Histologically confirmed malignant melanoma with measurable metastases in the brain.
Both asymptomatic and symptomatic patients.

2. Cohort A (asymptomatic patients): At least 1 measurable brain metastasis ≥ 0.5 cm in
and ≤ 3 cm in longest diameter that has not been previously irradiated. No clinical
requirement for local intervention (surgery, radiosurgery, corticosteroid therapy) or
other systemic therapy

Cohort B (symptomatic patients): Subjects with neurologic signs and symptoms related
to metastatic brain lesions are eligibile. Subjects must have at least 1 measurable
brain metastasis ≥ 0.5 cm in and ≤ 3 cm in longest diameter that has not been
previously irradiated. No immediate requirement (within 3 weeks prior to first
treatment) for local intervention (surgery, radiosurgery, corticosteroid therapy).
Steroid use is permitted as defined in the protocol.

3. Prior stereotactic radiotherapy (SRT) and prior excision of up to 3 melanoma brain
metastases is permitted if there has been complete recovery, with no neurologic
sequelae, and measurable lesions remain. Growth or change in a lesion previously
irradiated will not be considered measurable. Regrowth in cavity of previously excised
lesion will not be considered measurable. lesions or prior excision must have occurred
≥ 3 weeks before the start of dosing for this study

4. Must have tumor tissue available for biomarker analysis. Biopsy should be excisional,
incisional, punch, or core needle

5. Cohort A (asymptomatic): Subjects must be free of neurologic signs and symptoms
related to metastatic brain lesions and must not have required or received systemic
corticosteroid therapy within 10 days prior to first treatment.

Cohort B (symptomatic): Subjects with neurologic signs and symptoms related to
metastatic brain lesions are eligible per Amendment 02. Subjects with neurologic signs
and symptoms may be treated with a total daily dose of no more than 4 mg of
dexamethasone that is stable or tapering for 10 days prior to first treatment.
Subjects with neurologic signs and symptoms who are not being treated with steroids
are eligible for Cohort B and should have no experience of seizure within 10 days
prior to first treatment.

6. Allowable prior therapy:

1. Approved adjuvant therapies, which may include molecularly-targeted agents, IFN
α, and ipilimumab. Patients who received ipilimumab as adjuvant therapy must have
a 6 month washout before receiving any dosing on this study

2. For advanced disease, interleukin-2 at any dose and/or IFN-α (any formulation, no
washout required); MEK and BRAF inhibitors: washout for at least 4 weeks prior to
the start of dosing in this study

3. Steroids for physiological replacement are allowed.

7. Cohort A (asymptomatic): ECOG performance status ≤1 Cohort B (symptomatic): ECOG
performance status ≤2

Exclusion Criteria:

2. Target Disease Exceptions

1. History of known leptomeningeal involvement (lumbar puncture not required)

2. Previous stereotactic or highly conformal radiotherapy within 3 weeks before the start
of dosing for this study. Note the stereotactic radiotherapy field must not have
included the brain index lesion(s)

3. Brain lesions >3 lesions which were previously treated with SRT

4. Brain lesion size > 3cm 3. Medical History and Concurrent Diseases

a) History of whole brain irradiation b) Subjects with an active, known or suspected
autoimmune disease c) Subjects with major medical, neurologic or psychiatric condition who
are judged as unable to fully comply with study therapy or assessments should not be
enrolled d) Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in
situ of the cervix. For any prior invasive malignancy, at least 5 years must have elapsed
since curative therapy and patients must have no residual sequelae of prior therapy e)
Cohort A (asymptomatic): The use of corticosteroids is not allowed within 10 days prior to
first treatment (based upon 5 times the expected half life of dexamethasone) except
patients who are taking steroids for physiological replacement. If alternative
corticosteroid therapy has been used, consultation with the sponsor Medical Monitor is
required to determine the washout period prior to initiating study treatment Cohort B
(symptomatic): Subjects with neurologic sign and symptoms related to brain metastases who
are being treated with a total daily dose of higher than 4 mg dexamethasone or equivalent
within 10 prior to the start of treatment with study drug are excluded.

4. Physical and Laboratory Test Findings

1. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus
ribonucleic acid (HCV antibody) indicating acute or chronic infection

2. Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on ART—due to
the unknown effects of HIV on the immune response to combined nivolumab plus
ipilimumab or the unique toxicity spectrum of these drugs in patients with HIV

5. Allergies and Adverse Drug Reaction

a) History of allergy to study drug components b) History of severe hypersensitivity
reaction to any monoclonal antibody

6. Other Exclusion Criteria

1. Prisoners or subjects who are involuntarily incarcerated

2. Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (e.g., infectious disease) illness Eligibility criteria for this study have
been carefully considered to ensure the safety of the study subjects and that the
results of the study can be used. It is imperative that subjects fully meet all
eligibility criteria

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
36
sites
1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Phone: 404-778-4520
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-3754
?
mi
from
Boston, MA
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-5283
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Allentown, Pennsylvania 18105
Phone: 610-402-0636
?
mi
from
Allentown, PA
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
2845 Northeast 199th Street
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts 02115
Phone: 617-632-9293
?
mi
from
Boston, MA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4503
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chicago, Illinois 60141
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2109 Adelbert Road
Cleveland, Ohio 44106
Phone: 216-844-5393
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Detroit, Michigan 48201
Phone: 313-576-9730
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duarte, California 91010
Phone: 626256467380572
?
mi
from
Duarte, CA
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-686-1654
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
1872 Saint Luke's Boulevard
Easton, Pennsylvania 18045
Phone: 484-503-4153
?
mi
from
Easton, PA
Click here to add this to my saved trials
8505 Arlington Boulevard
Fairfax, Virginia 22031
Phone: 703-970-6548
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-792-2923
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90025
Phone: 310-231-2182
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
Phone: 310-794-3883
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
Phone: 732-235-8780
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4497
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Phone: 412-623-6130
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94115
Phone: 415-600-3613
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
?
mi
from
Washington,
Click here to add this to my saved trials