The primary objective of this study is to assess the frequency of human leukocyte antigen (HLA)-A*02:01genotype and tumoral expression of melanoma-associated antigen 1 (MAGE-A1) in subjects with relapsed/refractory, advanced-stage solid tumors that…
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Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to assess the frequency of HLA-A*02:01
genotype and tumoral expression of MAGE-A1 in subjects with
relapsed/refractory, advanced-stage solid tumors that may express MAGE-A1, are
in advanced, non-curable state, and have received at least one line of systemic
therapy for their disease.
The primary endpoints of this study are:
• Frequency of HLA-A*02:01 genotype
• Frequency of immunohistochemically MAGE-A1 positive tumors in subjects with
HLAA*02:01 genotype
Secondary outcome
The secondary objective of this study is to further explore the percentage of
positive tumor cells within the tumor and the overall intensity of target
expression.
The secondary endpoint of this study is:
• Percentage of positive tumor cells within the tumor, staining intensity (+,
++, +++) of the tumor cells, and derived histoscore for MAGE-A1 staining in the
tumor.
Background summary
Following the concept that the human immune system in principle is capable of
eliminating tumor cells, new T cell-based therapies have emerged that use
modification of the subject*s own immune cells to achieve an anti-tumor
response. One such promising approach is to make the subject*s own T cells
express a T cell receptor that recognizes a target antigen present via major
histocompatibility complex (MHC) on the subject*s tumor cells: a T cell
receptor (TCR) based therapy.
Such therapies, using autologous T cells, require that the target is expressed
by the tumor cells that are to be removed and that it is presented via MHC.
However, for many target antigens, the tumoral expression pattern has not been
well investigated across different indications and available research data may
only be partly reliable due to use of suboptimal techniques or reagents (e.g.,
use of non-specific antibodies) in many studies conducted so far.
One target antigen of interest is the melanoma-associated antigen 1 (MAGE-A1).
The presence of this antigen in a patient*s tumor may qualify them for
participation in currently ongoing clinical trials exploring TCR therapies
targeting this antigen. Yet, so far, no established standard screening methods
exist in clinical routine, assessing the presence of this antigen in tumors. At
of the date of initiation of this study, screening for this antigen is not
routinely done at clinical sites treating advanced-stage cancer patients who
may qualify for such treatments
Study objective
The primary objective of this study is to assess the frequency of human
leukocyte antigen (HLA)-A*02:01genotype and tumoral expression of
melanoma-associated antigen 1 (MAGE-A1) in subjects with relapsed/refractory,
advanced-stage solid tumors that may express MAGE-A1, are in advanced,
non-curable state, and have received at least one line of systemic therapy for
their disease.
The secondary objective of this study is to further explore the percentage of
positive tumor cells within the tumor and the overall intensity of target
expression.
Study design
This observational, non-interventional research study intends to assess the
overall frequency for positivity of HLA-A*02:01 genotype and the tumoral
expression of MAGE-A1 in subjects with relapsed/refractory, advanced-stage
solid tumors that may express MAGE-A1 (such as melanoma, squamous non-small
cell lung cancer [NSCLC], squamous cell carcinoma of the head and neck [SCCHN],
esophageal, gastric, breast [ductal, tubular,
medullary], ovarian, mesothelioma, bladder, anal, sarcomas, primitive
neuroectodermal [PNET], and other solid tumors), who are in advanced,
non-curable state, and have received at least one line of systemic therapy for
their disease.
A blood sample will be collected for HLA-A*02:01 genotyping (if not already
known from medical history) during a scheduled, routine blood draw and to have
a stored and accessible tumor sample available that can be stained for MAGE-A1
expression by immunohistochemistry (IHC).
Study burden and risks
This is a no treatment study, but the study has pure research purposes. The
single blood sample taken in this study will ideally be taken during a routine
blood draw. The usual possible risks associated with blood drawing are: pain,
bleeding, fainting, bruising, infection and/or hematoma (blood clot under the
skin) at the injection site.
The results from this research study may allow investigator to see if patient
can be qualified or not for clinical trials with novel immunotherapies. If
patient are not qualified, there is no other benefit in taking part in this
study. Either way, the collection of the test results and patient data may
provide valuable information to researchers on the number of certain genetic
constellations or tumor protein expression. This will help them to better
understand who may qualify for such treatments in the future and may help
future subjects suffering from cancer.
Robert-Roessle-Str. 10
Berlin 13125
DE
Robert-Roessle-Str. 10
Berlin 13125
DE
Listed location countries
Age
Inclusion criteria
1. Signed written informed consent.
2. Histologically or cytologically confirmed diagnosis of relapsed/refractory,
advanced stage solid tumor that may express MAGE-A1.
3. Subject received at least one line of approved systemic therapy and is
declared to be in a non-curable disease state as per treating physician*s
current assessment.
4. Availability of a stored, accessible tumor sample for IHC.
5. Ability to provide a blood sample.
6. Age >= 18 years.
7. Life expectancy > 6 months as per treating physician*s assessment.
Exclusion criteria
1. Any bleeding or coagulation disorder or other condition that would present
the subject with an undue risk when undergoing a venous blood draw.
2. Any other condition that could interfere with subject's safety, obtaining
informed consent, or compliance to the screening study procedures.
3. Presence of any organ toxicities or other conditions that would preclude
intense future anticancer treatments such as required for T cell receptor
therapy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83819.041.23 |