We encourage participation in clinical trials
for research leading to a cure for mesothelioma. It is known that nationally
the statistics for participation in adult cancer trials is between 3-5% of
adults who have a cancer diagnosis.
For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov
Our goal is to feature one mesothelioma clinical
trial monthly and break it down to understandable terms, to decipher the
eligibility requirements, and to possibly encourage participation in these trials.
The official title to the Clinical Trial; Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of
Malignant Mesothelioma.
Purpose: The purpose of
this study is to find out whether the combination of avelumab and Stereotactic Body
Radiation Therapy- SBRT is safe and what effect avelumab has on mesothelioma
when given in combination with SBRT. In addition, a goal of this protocol is to
study the effect of radiation therapy on the immune system. It is thought that radiation treatment may
create a form of “vaccine” against cancer inside the body and immunotherapy may
improve this effect. The combination of radiation treatment and immunotherapy
may be more effective against cancer than either radiation or immunotherapy
alone.
Sponsor: Memorial Sloan
Kettering Cancer Center in collaboration with Pfizer.
Start Date: December 20, 2017
Completion Date: December 2020
Estimated Enrollment: 27 participants
How it Works: Treatment consists of one dose of avelumab every other week as well as a short
course of SBRT after the first two doses of avelumab. The drug, avelumab is
delivered by IV infusion. The SBRT is given after the first two doses of
avelumab.
Criteria:
Inclusion: Over age 18
Be willing and able to provide written
informed consent
Histologically or
cytologically confirmed malignant pleural or peritoneal mesothelioma.
No plans for
surgical resection
At least one prior
line of systemic therapy. Patients on prior immunotherapy are eligible.
At least one
targetable lesion appropriate for palliative SBRT and one non-target lesion.
Karnofsky
Performance Score > 70%
If of childbearing
potential, must be willing to use highly effective mode of contraception
For at least one
month prior, during, and for 2 months after the end of active therapy
Adequate organ function demonstrated by lab tests- see www.clinicaltrials.gov for parameters
If the patient
received major surgery, they must have recovered adequately from the toxicity
and/or complications from the intervention prior to starting therapy.
Exclusion:
Currently participating
and receiving another study therapy or has participated in a study of an
investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment.
Prior radiation therapy
precluding SBRT
Continuous oxygen use
Current use of immunosuppressive medications- for exceptions see www.clinicaltrials.gov
Active autoimmune disease
that might deteriorate when receiving an immunostimulatory agent.
Known prior severe
hypersensitivity to investigational product or Ny component in its
formulations, including known severe hypersensitivity reactions to monoclonal
antibodies.
Patient who rapidly
progressed on prior immunotherapy, as determined by the treating physician, are
not eligible.
Prior Therapies:
- Treatment
with a monoclonal antibody within 4 weeks prior to study Day 1 or has not
recovered from adverse events due to agents administered.
- Prior
chemotherapy, targeted small molecule therapy, within 4 weeks prior to study
Day 1 or has not recovered from adverse events due to previously administered
agent.
- Prior
therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-Cytotoxic T-lymphocyte- associated antigen-4 (CTLA-4) antibody (including
ipiliumab or any other antibody or drug specifically targeting T-cell
co-stimulation or checkpoint pathways) within 4 weeks prior to study Day 1or
has not recovered from adverse events.
Comorbidities or Prior Conditions
- Known
psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial.
- Prior
organ transplantation including allogenic stem-cell transplantation.
- Known
additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of
the skin, or in situ cervical cancer that has undergone potentially curative
therapy.
- Known
history of active TB
- Known
history of HIV or known acquired immunodeficiency syndrome.
- Active
Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection at screening or
positive serologies indicating prior infection.
- Active
infection requiring systemic therapy.
- Evidence
of interstitial lung disease or active, non-infectious pneumonitis.
- Clinically
significant cardiovascular disease, cerebro vascular accidents/stroke,
myocardial infarction, unstable angina, congestive heart failure, or serious
cardiac arrythmia requiring medication.
Pregnant women or women who are breastfeeding or of
childbearing potential and not using a highly effective means of birth control.
Vaccinations within 4 weeks prior to the first dose of
avelumab and while on trial is prohibited except for administration of
inactivated vaccines.
Concomitant use of the following medications
- Any
investigational anticancer therapy
- Any
concurrent chemotherapy, immunotherapy, or biologic therapy. Concurrent use of hormones for non-cancer
related conditions (e.g. Insulin for diabetes and hormone replacement therapy)
is acceptable.
- Immunosuppressive
medications including, but not limited to systemic corticosteroids,
methotrexate, azathioprine, and tumor necrosis factor alpha blockers. Use of
immunosuppressive medications for the management of investigational
product-related AEs, in subjects with contrast allergies is acceptable. In
addition, use of inhaled and intranasal corticosteroids is permitted.
Known contraindications to radiotherapy.
| | | | |
| Contact:
Andreas Rimner, MD | 212-639-6025 | rimnera@mskcc.org | |
| Contact:
Marjorie Zauderer, MD | 646-888-4656
| | |
Definitions from www.cancer.gov
With any
clinical trial, all participation is voluntary.
Before enrollment a detailed consent form will be reviewed with the
participant and signed. The participant
can withdraw from a clinical trial at any point in time. Think about
participating if able, the only way to progress to a cure for mesothelioma is
through clinical trials.
Immunotherapy
A type
of therapy that uses substances to stimulate or suppress the immune system to
help the body fight cancer, infection, and other diseases. Some types of
immunotherapy only target certain cells of the immune system. Others affect the
immune system in a general way. Types of immunotherapy include cytokines,
vaccines, bacillus Calmette-Guerin (BCG), and some monoclonal antibodies.
Stereotactic
Body Radiation Therapy
A type
of external radiation therapy that uses special equipment to position a patient
and precisely deliver radiation to tumors in the body (except the brain). The
total dose of radiation is divided into smaller doses given over several days.
This type of radiation therapy helps spare normal tissue.
Avelumab
A drug
used with axitinib to treat advanced renal cell carcinoma (a type of kidney
cancer) that has not already been treated. It is also used to treat urothelial
carcinoma (a type of bladder cancer) that is locally advanced or has spread to
other parts of the body. It is used in patients whose disease got worse during
or after treatment with anticancer drugs that included platinum. Avelumab is
also used to treat Merkel cell carcinoma (a rare type of skin cancer) that has
spread to other parts of the body. It is also being studied in the treatment of
other types of cancer. Avelumab binds to a protein called PD-L1, which is found
on some cancer cells. Avelumab may block PD-L1 and help the immune system kill
cancer cells. It is a type of monoclonal antibody and a type of immune
checkpoint inhibitor. Also called Bavencio.
Immune
system
A
complex network of cells, tissues, organs, and the substances they make that
helps the body fight infections and other diseases. The immune system includes
white blood cells and organs and tissues of the lymph system, such as the
thymus, spleen, tonsils, lymph nodes, lymph vessels, and bone marrow.
Clinical Trials are where new drugs or treatments are evaluated, which is ultimately how progress is made in treating diseases. Theories are tested, and through the rigorous scientific process, evaluated. The findings must stand up to peer reviews and be duplicatable. Clinical Trials are done in stages and require rigorous adherence to the approved protocols.