Solid and Hematological MalignanciesNCT02636855
Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
An observational study of Solid and Hematological Malignancies, run by Adaptimmune at 36 sites in 4 countries.
Trial summary
This screening study is intended for men and women ≥ 18 to ≤ 75 years of age who have advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen (HLA) subtype and tumor antigen expression profile. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid and Hematological Malignancies
- How many people
- 9,122 participants
- Where
- 36 sitesin 4 countries
- Study dates
- Dec 2015to 28 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease
Who may be able to join
- Signed written informed consent;
- Histologically or cytologically confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease, as described in the respective Adaptimmune clinical treatment protocol (including, but not limited to myeloma, melanoma, NSCLC, head and neck, gastric and bladder cancer);
- Male or female ≥ 18 to ≤75 years of age;
- Life expectancy > 3 months;
- Ability to provide a blood sample;
- Ability to provide one of the following tumor tissue samples:
Show all 9Show fewer
- formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, OR
- a fresh biopsy is feasible, OR;
- a FFPE archival primary tumor block or tissue sections
Who cannot join
- Any bleeding diathesis or coagulopathy, which at the discretion of the Investigator may put the subject at risk.
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the screening study procedures.
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
United States25 sites
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21157
Upper Chesapeake Medical Center, Patricia D. and M. Scot Kaufman Cancer Center
Bel Air, Maryland, 21014
Boca Raton Regional Hospital, Lynn Cancer Institute, 701 NW 13th Street
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14040
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91101
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina, 27710
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46033
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Oncology- Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Orlando Health
Orlando, Florida, 32806
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Northwest Oncology and Hematology
Rolling Meadows, Illinois, 60008
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Institute (Stanford University)
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
UMD St. Joseph Medical Center
Towson, Maryland, 21204
Spain8 sites
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital 12 De Octubre
Madrid, 28041
Hospital Universitario 12 Octubre Avda. de Córdoba s/n
Madrid, 28041
Centro Integral Oncológico Clara Campal, HM CIOCC (START MADRID-CIOCC)
Madrid, 28050
University Hospital of Navarra (Pamplona)
Pamplona, Navarre, 31008
Hospital Virgen del Rocio, Sevillia
Seville, 41013
Hospital Clinico Universitario de Valencia
Valencia
United Kingdom2 sites
University College Hospital Macmillan Cancer Centre
London, WC1E 6AG
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects With Solid and Hematological Malignancies
This screening study is intended for men and women ≥ 18 to ≤ 75 years of age who have advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen (HLA) subtype and tumor antigen expression profile. Based on the results, it will be determined if a subject is eligible to be considered for Adaptimmune sponsored clinical trials testing the safety and efficacy of genetically changed T cells targeting specific tumor antigens. No treatment intervention will occur as part of this screening study.
Upon enrollment, subjects will be required to provide a blood sample for HLA subtype analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion criteria and do not express the HLA subtypes that are exclusionary for the available interventional clinical trial(s), then the subject will be required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at a central laboratory for the expression (protein or gene) of multiple antigens which may include, but are not limited to MAGE-A4. Based upon the results of these diagnostic analyses, if eligible, subjects will be referred to an appropriate available interventional clinical trial(s) at the discretion of the Investigator.
Following screening, tumor samples will be retained by Adaptimmune for the purpose of developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling which is required for regulatory approval of a new therapeutic product indication.
Read the detailed description
This multicenter screening study will be conducted in order to determine a subject's tumor antigen expression profile and HLA subtype, and subsequent eligibility for Adaptimmune sponsored clinical treatment trials studying the safety and efficacy of autologous genetically modified T-cells engineered with enhanced TCRs targeting specific antigens. No treatment intervention will occur as part of this screening study. Specific Adaptimmune sponsored interventional protocols have been designated to utilize this screening protocol to determine preliminary eligibility. Therefore, details of the available interventional clinical trial(s) (e.g., HLA subtype, tumor antigen, and other eligibility criteria) should be understood before consenting subjects for this screening protocol.
For this screening study, subjects with confirmed advanced solid or hematologic malignancy or recurrent disease, as described in the respective Adaptimmune clinical trial protocol(s), will be required to provide a blood sample for diagnostic analysis. The blood sample will be used for HLA subtype analysis. If the results of the analysis match the HLA subtype specified in the available interventional clinical trial(s), then the subject will be required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at a central laboratory for the expression (gene or protein) of multiple antigens using Clinical Trial Assays. The Clinical Trial Assays to be used in this protocol have undergone CLIA validation to establish the sensitivity, specificity and performance of the assays. The antigens to be screened may include, but are not limited to the following: NY-ESO-1 and/or LAGE-1a and MAGE-A10. Based upon both the tumor antigen expression and the HLA subtype, if eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.
The secondary objective of the study is the collection and analysis of tumor tissue specimens to enable the development and validation of single and/or multiple-marker ('multiplex') IVD assay(s) for antigen expression profiling. It is a regulatory requirement to develop the IVD(s) as a companion diagnostic(s) to accompany a future new indication drug application(s). Therefore all tumor specimens from this study will be retained by Adaptimmune for companion diagnostic validation purposes.
- Conditions
- Solid and Hematological Malignancies
- Keywords
- Solid and Hematological Malignancies, Screening, Metastatic, Previously Treated, MAGE-A4, Neoplasms
- Medical subject headings
- Hematologic Neoplasms, Neoplasm Metastasis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of subjects with the expression (gene or protein) of multiple antigens (including, but are not limited to MAGE-A4 , and others) [ Time Frame: 10 years ]
To screen subject tumor tissue in order to determine their tumor antigen expression profile, and HLA subtype, for subsequent assessment of eligibility for various Adaptimmune sponsored targeted T cell therapy clinical trials.
Measured: 10 years
Secondary outcomes (1)
Retention of screening tumor tissue for the future development and validation of single and/or multi-plex companion diagnostic platforms for the detection of tumor antigen expression. [ Time Frame: 10 years ]
Following screening for the antigen expression profile, remaining screening tissue will be used for the purpose of developing and validating companion diagnostic assays for antigen screening for regulatory approval. Tumor tissue will be used for the analytical validation (which includes testing for efficiency, sensitivity, specificity, exclusivity, accuracy and precision), as well as the clinical validation of such diagnostic assays.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid and Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636855
- Sponsor's protocol ID
- ADP-0000-001
- Status last verified
- Feb 2025
- First submitted
- 23 Nov 2015
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects With Solid and Hematological Malignancies
- ClinicalTrials.gov ID
- NCT02636855
- Acronym / sponsor ID
- ADP-0000-001
- Conditions
- Solid and Hematological Malignancies
- Keywords
- Solid and Hematological Malignancies, Screening, Metastatic, Previously Treated, MAGE-A4, Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,122 participants (actual)
- Lead sponsor
- AdaptimmuneIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This screening study is intended for men and women ≥ 18 to ≤ 75 years of age who have advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen (HLA) subtype and tumor antigen expression profile. Based on the results, it will be determined if a subject is eligible to be considered for Adaptimmune sponsored clinical trials testing the safety and efficacy of genetically changed T cells targeting specific tumor antigens. No treatment intervention will occur as part of this screening study.
Upon enrollment, subjects will be required to provide a blood sample for HLA subtype analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion criteria and do not express the HLA subtypes that are exclusionary for the available interventional clinical trial(s), then the subject will be required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at a central laboratory for the expression (protein or gene) of multiple antigens which may include, but are not limited to MAGE-A4. Based upon the results of these diagnostic analyses, if eligible, subjects will be referred to an appropriate available interventional clinical trial(s) at the discretion of the Investigator.
Following screening, tumor samples will be retained by Adaptimmune for the purpose of developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling which is required for regulatory approval of a new therapeutic product indication.
Detailed description
This multicenter screening study will be conducted in order to determine a subject's tumor antigen expression profile and HLA subtype, and subsequent eligibility for Adaptimmune sponsored clinical treatment trials studying the safety and efficacy of autologous genetically modified T-cells engineered with enhanced TCRs targeting specific antigens. No treatment intervention will occur as part of this screening study. Specific Adaptimmune sponsored interventional protocols have been designated to utilize this screening protocol to determine preliminary eligibility. Therefore, details of the available interventional clinical trial(s) (e.g., HLA subtype, tumor antigen, and other eligibility criteria) should be understood before consenting subjects for this screening protocol.
For this screening study, subjects with confirmed advanced solid or hematologic malignancy or recurrent disease, as described in the respective Adaptimmune clinical trial protocol(s), will be required to provide a blood sample for diagnostic analysis. The blood sample will be used for HLA subtype analysis. If the results of the analysis match the HLA subtype specified in the available interventional clinical trial(s), then the subject will be required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at a central laboratory for the expression (gene or protein) of multiple antigens using Clinical Trial Assays. The Clinical Trial Assays to be used in this protocol have undergone CLIA validation to establish the sensitivity, specificity and performance of the assays. The antigens to be screened may include, but are not limited to the following: NY-ESO-1 and/or LAGE-1a and MAGE-A10. Based upon both the tumor antigen expression and the HLA subtype, if eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.
The secondary objective of the study is the collection and analysis of tumor tissue specimens to enable the development and validation of single and/or multiple-marker ('multiplex') IVD assay(s) for antigen expression profiling. It is a regulatory requirement to develop the IVD(s) as a companion diagnostic(s) to accompany a future new indication drug application(s). Therefore all tumor specimens from this study will be retained by Adaptimmune for companion diagnostic validation purposes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease
Key inclusion criteria (9 listed)
- Signed written informed consent;
- Histologically or cytologically confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease, as described in the respective Adaptimmune clinical treatment protocol (including, but not limited to myeloma, melanoma, NSCLC, head and neck, gastric and bladder cancer);
- Male or female ≥ 18 to ≤75 years of age;
- Life expectancy > 3 months;
- Ability to provide a blood sample;
Key exclusion criteria (2 listed)
- Any bleeding diathesis or coagulopathy, which at the discretion of the Investigator may put the subject at risk.
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the screening study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of subjects with the expression (gene or protein) of multiple antigens (including, but are not limited to MAGE-A4 , and others) [ Time Frame: 10 years ]
Time frame: 10 years
To screen subject tumor tissue in order to determine their tumor antigen expression profile, and HLA subtype, for subsequent assessment of eligibility for various Adaptimmune sponsored targeted T cell therapy clinical trials.
1 secondary outcome
Retention of screening tumor tissue for the future development and validation of single and/or multi-plex companion diagnostic platforms for the detection of tumor antigen expression. [ Time Frame: 10 years ]
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid and Hematological Malignancies, run by Adaptimmune at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Spain, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of subjects with the expression (gene or protein) of multiple antigens (including, but are not limited to MAGE-A4 , and others) [ Time Frame: 10 years ] (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.