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

Completed · Phase 2

Conditions studied: Carcinoma, Merkel Cell

In brief

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

Key facts

Study ID: NCT02155647
Run by: EMD Serono Research & Development Institute, Inc.
People needed: 204
Starts: 2014-07-03
Expected to finish: 2023-05-03
Last updated by the study team: 2024-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed written informed consent
Age 18 years and above
Histologically proven MCC
Participants 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 - Participants 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 participants, if the risk of conception exists
Fresh Biopsy or Archival Tumor Tissue
Estimated life expectancy of more than 12 weeks

You may not qualify if…

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 participant 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, participants 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: Participants receiving bisphosphonate or denosumab are eligible.
Participants with active central nervous system (CNS) metastases are excluded. Participants 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 participants 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 participant'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)

Where it is running

The Angeles Clinic and Research Institute - West LA — Los Angeles, California, United States
University of Colorado — Aurora, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc — Tampa, Florida, United States
National Cancer Institute — Bethesda, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Washington University School of Medicine — St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Mount Sinai — New York, New York, United States
Peggy & Charles Stephenson Oklahoma Cancer Center — Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
University of Pittsburgh — Pittsburgh, Pennsylvania, United States
University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States
Port Macquarie Base Hospital — Port Macquarie, New South Wales, Australia
Royal North Shore Hospital — St Leonards, New South Wales, Australia
Tasman Oncology Research Ltd — Southport, Queensland, Australia
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre — East Melbourne, Victoria, Australia
St John of God Subiaco Hospital — Perth, Western Australia, Australia
CHU Nice - Hopital de l Archet 2 — Nice, Alpes Maritimes, France
Hôpital de la Timone — Marseille, Bouches-du-Rhône, France
CHU Besançon - Hôpital Jean Minjoz — Besançon, Doubs, France
CHU Nantes - Hôtel Dieu — Nantes, Loire Atlantique, France
Hopital Claude Huriez - CHU Lille — Lille, Nord, France
UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.