Treating Unresectable Mesothelioma with Durvalumab and Chemotherapy
Status: No Longer Recruiting
Type: Pleural Mesothelioma
This trial tests durvalumab with chemotherapy for patients with unresectable pleural mesothelioma.
Using Durvalumab and Chemotherapy
The goal of this clinical trial is to see if adding durvalumab to standard chemotherapy will help improve overall survival. Participants in this clinical trial will receive the drug durvalumab and standard first-line chemotherapy of pemetrexed and cisplatin.
Components of This Trial
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Immunotherapy– is a treatment that uses the immune system to fight cancer. During this type of therapy the immune system is either stimulated or is given man-made proteins to attack the cancer cells.
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Chemotherapy – is a treatment that includes a medication or combination of medications to either stop or slow the growth of cancer cells. This type of treatment has many side effects because it affects a patient’s entire body.
Research has revealed that chemotherapy and immunotherapy work well when combined. They work together by destroying any dormant cancer cells. Destroying these cancer cells helps eliminate the chances of a patient’s cancer occurring again.
Get Help Enrolling in This Trial
Reasons to get involved in this trial include:
- Receive proven life-extending treatment
- Get treated with both chemotherapy and immunotherapy
- Participants can remain in study until their disease progresses
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PrECOG, LLC.
SponsorOpen Label, Phase II Study of Anti - Programmed Death - Ligand 1 Antibody, Durvalumab (MEDI4736), in Combination With Chemotherapy for the First-Line Treatment of Unresectable Mesothelioma
Official TitleNCT02899195
Clinical Trial IDPleural
Mesothelioma55
ParticipantsLocations
- United States
Drugs Used in the Trial
Patients will receive the immunotherapy drug, durvalumab, along with standard chemotherapy of pemetrexed and cisplatin. Patients who have a bad reaction with cisplatin may be given carboplatin as a substitute.
Here is some information about each of the drugs in this trial:
Durvalumab – this anti-PD-L1 antibody helps the immune system to detect cancer and to reactivate the immune response. Researchers believe that this drug may help slow down the growth of cancer or it may aide in killing cancer cells.
Pemetrexed – this chemotherapy drug interferes with cell metabolism and stops cells from dividing. Pemetrexed has been used in treatments for malignant mesothelioma and advanced or metastatic nonsquamous non small cell lung cancer.
Cisplatin – this chemotherapy drug works by damaging the DNA of a cell. By doing this, it stops a cell from duplicating. Cisplatin is combined with pemetrexed as first line therapy for mesothelioma.
If a participant in the study is ineligible to use cisplatin due to impaired renal function or is experiencing cisplatin related toxicity, the drug carboplatin will be used instead.
Carboplatin – this drug interferes with the DNA of a cell. By doing this, it prohibits cancer cells to grow. Some cancers that carboplatin has been used to treat are ovarian, lung, bladder, breast, and esophageal.
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What to Expect
Participants will be given durvalumab, followed by pemetrexed and then cisplatin on day 1 of a 3 week cycle. If a participant cannot have cisplatin, it will be substituted with carboplatin for the same length of time.
After cycle 6 of treatment, if a participant’s disease is stable and is responding to the therapy, they will be able to continue receiving durvalumab. They will continue receiving treatment with durvalumab every 3 weeks or until their disease progresses. Researchers anticipate that participants will be able to do this for up to 12 months.
Side Effects
Participants in this clinical trial may experience a variety of different types of side effects because of the drugs that are involved in this study. Some side effects may be more severe than others.
Some side effects patients may experience are:
- Fatigue
- Constipation
- Nausea
- Cough
- Loss of appetite
Trial Eligibility
To participate in this clinical trial an individual must have:
- Confirmed malignant pleural mesothelioma
- Unresectable disease
- Not participated in another clinical trial for an investigational drug in the last 4 weeks
- No prior systemic therapy, including chemotherapy
When it comes to finding a clinical trial that is best for you, it is always best to consult your doctor and to talk it over with your loved ones. If you have any questions or need help finding the right clinical trial for you, please contact Jenna Campagna.