Open-label Uncontrolled Non-Interventional Retrospective Study to Evaluate Molecular Determinants of Outcome to the Immune Checkpoint Inhibitors (Anti-PD-1/Anti-PD-L1 Monoclonal Antibodies) Treatment for Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 6, 2023
  • participants needed
    400
  • sponsor
    Asylia Diagnostics BV
Updated on 3 May 2021

Summary

The recent approval of ICB treatments targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death-1 (PD-1/PD-L1) by the US Food and Drug Administration has offered an improved treatment chance for a variety of malignant tumors, including those with a particularly poor prognosis. However, a growing number of studies and case reports show that immunotherapy may accelerate tumor progression in a significant subset of patients ranging from 9% to 27% across multiple histologies and lead to so-called hyperprogressive disease (HPD) that leads to a rapid patient death.

During this NIS study, Asylia Diagnostics aims to fill in the first layer of knowledge leading to the identification of predictive biomarkers and biological mechanisms that could be used for the prediction, diagnosis, and treatment of melanoma and NSCLC HPD patients.

The study is a retrospective clinical study. During this study basic historical medical information and scrolls from FFPE-preserved biopsies taken prior to immunotherapy treatment will be collected. The nature of the study is not invasive and non interruptive to the standard of care.

Details
Condition Pulmonary Disease, melanoma, Lung Neoplasm, skin cancer, Bronchial Neoplasm, Metastatic Melanoma, Lung Cancer, Malignant Melanoma, Lung Disease, carcinoma lung, lung carcinoma
Treatment Pembrolizumab
Clinical Study IdentifierNCT04860076
SponsorAsylia Diagnostics BV
Last Modified on3 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Females and males 18-95 y.o
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >/=70%)
Histologically or cytologically confirmed melanoma or lung cancer, the grade of the tumor, diagnosed before enrolment into the study
Treatment with anti-PD1/anti-PD-L1 drugs and anti-PD1/anti-PD-L1 drugs in combinations with other therapies
Subjects may have received any number of prior lines of chemotherapy or targeted therapies
Availability of FFPE tissue samples received prior to any type of antitumor treatment start
Complete medical records (stage, receptors status, demographic data)

Exclusion Criteria

Has had chemotherapy, targeted small molecule therapy, or radiation therapy >30 Gray within 14 days prior to the baseline biopsy or persistent adverse events (AE) related to prior therapy, which have not recovered (i.e., AEs should be Grade 1 or the value collected at baseline) from AEs due to a previously administered intervention
Any evidence of uncontrolled system pathology, active infections, active bleeding diathesis, renal graft, hepatitis B, C or HIV
Autoimmune diseases such as Addison's disease, thyroiditis, lupus (SLE), Sjogren's syndrome, scleroderma, myasthenia gravis, Grave's disease, and Goodpasture's syndrome, requiring active therapy with corticosteroids. If a patient has been taking steroids, at least 2 weeks must have passed since the last dose. Patients with a history of endocrinopathies (e.g. hypothyroidism, adrenal insufficiency, hypopituitarism) are eligible if they are stable on hormone replacement therapy
Patients with prior splenectomy, ocular melanoma
Recent (within 1 year) history of another cancer with the exceptions of non-melanoma skin cancer, superficial bladder cancer, or localized cervical cancer
Pregnant patients
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note