Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200)



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:9/29/2018
Start Date:July 3, 2014
End Date:April 30, 2023

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

A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the
efficacy and safety of avelumab in subjects with metastatic Merkel cell carcinoma (MCC).


Inclusion Criteria:

- Signed written informed consent

- Age 18 years and above

- Histologically proven MCC

- Subjects must have received at least 1 line of chemotherapy for metastatic MCC and
must have progressed after the most recent line of chemotherapy

- For Part B - Subjects must not have received any prior systemic treatment for
metastatic MCC. Prior chemotherapy treatment in the adjuvant setting (no clinically
detectable disease; no metastatic disease) is allowable if the end of treatment
occurred at least 6 months prior to study start)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST
Version 1.1 (including skin lesions)

- Adequate hematological, hepatic and renal function (renal function considered adequate
as per protocol definition)

- Highly effective contraception for both male and female subjects, if the risk of
conception exists

- Fresh Biopsy or Archival Tumor Tissue

- Estimated life expectancy of more than 12 weeks

Exclusion Criteria:

- Participation in another interventional clinical trial within the past 30 days
(participation in observational studies is permitted)

- Concurrent treatment with a non permitted drug

- Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune
checkpoints) such as antiprogrammed death 1 (PD-1), anti-PD-L1, or anticytotoxic
T-lymphocyte antigen-4 (CTLA-4) antibody; for Part B, the Investigator must consult
with the Medical Monitor and consider other co-regulatory targets such as 4-1BB

- Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy
[with the exception of palliative bone-directed radiotherapy, or radiotherapy
administered on non-target superficial lesions], immune therapy, or cytokine therapy
except for erythropoietin). Radiotherapy administered to superficial lesions is not
allowed if such lesions are considered target lesions in the efficacy evaluation or
may influence the efficacy evaluation of the investigational agent

- Major surgery for any reason, except diagnostic biopsy, within 4 weeks and/or if the
subject has not fully recovered from the surgery within 4 weeks

- Concurrent systemic therapy with steroids or other immunosuppressive agents, or use of
any investigational drug within 28 days before the start of trial treatment.
Short-term administration of systemic steroids (that is, for allergic reactions or the
management of immune-related adverse events [irAE]) while on study is allowed. Also,
subjects requiring hormone replacement with corticosteroids for adrenal insufficiency
are eligible if the steroids are administered only for the purpose of hormonal
replacement and at doses <= 10 mg or equivalent prednisone per day. Note: Subjects
receiving bisphosphonate or denosumab are eligible.

- Subjects with active central nervous system (CNS) metastases are excluded. Subjects
with a history of treated CNS metastases (by surgery or radiation therapy) are not
eligible unless they have fully recovered from treatment, demonstrated no progression
for at least 2 months, and do not require continued steroid therapy

- Previous malignant disease (other than MCC) within the last 5 years with the exception
of basal or squamous cell carcinoma of the skin and for Part A cervical carcinoma in
situ or for Part B carcinoma in situ (skin, bladder, cervical, colorectal, breast or
low grade prostatic intraepithelial neoplasia or Grade 1 prostate cancer)

- Prior organ transplantation, including allogeneic stem-cell transplantation

- Part A: Known history of testing positive for HIV or known acquired immunodeficiency
syndrome (AIDS) or any positive test for hepatitis B virus or hepatitis C virus
indicating acute or chronic infection. For Part B, known history of testing positive
for HIV or known AIDS in consultation with the Medical Monitor or HBV or HCV infection
at screening (positive HBV surface antigen or HCV RNA if anti- HCV antibody screening
test positive).

- Active or history of any autoimmune disease (except for subjects with vitiligo) or
immunodeficiencies that required treatment with systemic immunosuppressive drugs

- Known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than
or equal to (>=) 3 NCI CTCAE v 4.0), any history of anaphylaxis, or uncontrolled
asthma (that is, 3 or more features of partially controlled asthma)

- Persisting toxicity related to prior therapy Grade > 1 NCI-CTCAE v 4.0; however,
sensory neuropathy Grade <= 2 is acceptable 14. Pregnancy or lactation

- Known alcohol or drug abuse

- Clinically significant (that is, active) cardiovascular disease: cerebral vascular
accident / stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months
prior to enrollment), unstable angina, congestive heart failure (New York Heart
Association Classification Class >= II), or serious cardiac arrhythmia requiring
medication

- All other significant diseases (for example, inflammatory bowel disease), which, in
the opinion of the Investigator, might impair the subject's tolerance of trial
treatment

- Any psychiatric condition that would prohibit the understanding or rendering of
informed consent

- Legal incapacity or limited legal capacity

- Non oncology vaccine therapies for prevention of infectious disease (for example,
seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of trial drug
administration. Vaccination while on trial is also prohibited except for
administration of inactivated vaccines (for example, inactivated seasonal influenza
vaccine)
We found this trial at
15
sites
New Brunswick, New Jersey 08903
Phone: 732-235-6080
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-623-3483
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-3242
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
Aurora, Colorado 80045
Phone: 720-848-0590
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Bethesda, Maryland
Phone: 301-496-6770
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-3090
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
Los Angeles, California 90025
Phone: 310-230-2121
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Phone: 310-794-4955
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
New York, New York
?
mi
from
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4159
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
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
Phone: 215-214-4297
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Port Macquarie, New South Wales 2444
?
mi
from
Port Macquarie,
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Seattle, Washington 98109
Phone: 206-288-6765
?
mi
from
Seattle, WA
Click here to add this to my saved trials