Refractory CancerNCT03760952
Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling
An observational study of Refractory Cancer and Recurrent Cancer, run by Immatics US, Inc. at 4 sites in United States.
Trial summary
This screening study will identify HLA molecular subtype positive and tumor antigen target(s) positive patients who may be eligible for enrollment into Immatics clinical studies. This screening study is intended for patients with advanced and/or metastatic solid cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Cancer, Recurrent Cancer, Adult Solid Tumor
- How many people
- 242 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Feb 2019to 15 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed advanced and/or metastatic solid tumors
Who may be able to join
- Signed an Informed Consent Form (ICF)
- Patients ≥ 18 years of age
- Patients with confirmed advanced and/or metastatic solid tumors.
- For liver cancer patients, the diagnosis must be confirmed
- Pathological diagnosis of liver cancer based on biopsy/resection is required
- For patients without pathological diagnosis, an imaging technique obtained by computed tomography (CT) scan or magnetic resonance imaging (MRI) is needed.
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 0-1
- Life expectancy > 6 months
- There is no limitation for prior anti-cancer treatments
- HLA molecular phenotype positive.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)1.1
- At least one lesion considered accessible for biopsy unless fresh tumor tissue is being collected during a surgical procedure directed towards tumor treatment or palliative therapy or the patient has uterine cancer (including endometrial cancer or uterine carcinosarcoma) or melanoma
- Patient has adequate pulmonary function
- Acceptable organ and marrow function
- Acceptable coagulation status
- Adequate hepatic function
- Acceptable levels of serum creatinine
- For liver cancer patients only, Child-Pugh score of < 6
Who cannot join
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
- Patients with primary central nervous system (CNS)/brain tumors
- Patients whose tumors have very low expression of tumor antigen targets such as kidney chromophobe, thyroid carcinoma, and prostate adenocarcinoma
- Patients who are pregnant or are breastfeeding
- Patients with serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents
- Patients with prior stem cell transplantation or solid organ transplantation
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- Any condition contraindicating leukapheresis
- Patients with any of the following cardiac conditions: uncontrolled hypertension despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure, baseline left ventricular ejection fraction ≤ 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate > 100 bpm, unstable ischemic heart disease
- Patients with active diverticulitis, intra-abdominal abscess, or GI obstruction
- Patients with active pneumonitis
- Patients with active (uncontrolled/untreated) brain metastases NOTE: Patients with a history of brain metastases may be eligible, if an imaging scan with contrast enhancement not older than 4 weeks is able to exclude the existence of currently active brain metastasis.
- History of hypersensitivity on fludarabine (FLU), cyclophosphamide (CY), or interleukin (IL)-2
- History of current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator.
- Patients with Grade 3 or Grade 4 immune-related toxicities related to checkpoint inhibitors or patients requiring corticosteroid treatment (≥ 10 mg/day prednisone or equivalent dose).
- Patients with bleeding diathesis or coagulopathy
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with patient's safety
- HIV infection, active hepatitis B or C infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and/or nucleic acid testing
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Chicago
Chicago, Illinois, 60637
Oncology Consultants
Houston, Texas, 77030
Columbia University Medical Center
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
This screening study will identify HLA molecular subtype positive and tumor antigen target(s) positive patients who may be eligible for enrollment into Immatics clinical studies. This screening study is intended for patients with advanced and/or metastatic solid cancers. No treatment intervention will occur as part of this screening study.
Read the detailed description
The purpose of this screening study is to identify human leukocyte antigen (HLA) molecular subtype positive and tumor antigen target(s) positive patients. No treatment intervention will occur as part of this screening study.
After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA molecular subtype positivity. Patients that are HLA molecular subtype positive are then assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh tumor tissue obtained by a biopsy for this screening study will be required. If the patient is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be collected during the procedure to avoid the patient being subjected to another biopsy.
Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic (IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker analyses and validation studies for regulatory approval.
Immatics is conducting clinical studies which target patients with advanced and/or metastatic solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies of adoptive cell therapy (ACT).
- Conditions
- Refractory Cancer, Recurrent Cancer, Adult Solid Tumor, Neoplasms
- Keywords
- T-cell therapy, Immunotherapy, Screening, Metastatic, Previously Treated
- Medical subject headings
- Neoplasms, Recurrence, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with protocol-specified HLA subtype
Measured: 3 years
Frequency of patients with expression of analyzed tumor antigen targets
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start26 Feb 2019
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory CancerStudies 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immatics US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cedrik Britten, M.D., Study director, Immatics US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760952
- Sponsor's protocol ID
- IMA-SCREENING
- Status last verified
- Feb 2025
- First submitted
- 29 Nov 2018
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling
- ClinicalTrials.gov ID
- NCT03760952
- Acronym / sponsor ID
- IMA-SCREENING
- Conditions
- Refractory Cancer, Recurrent Cancer, Adult Solid Tumor, Neoplasms
- Keywords
- T-cell therapy, Immunotherapy, Screening, Metastatic, Previously Treated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Immatics US, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 3 Dec 2018 (actual)
- 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 will identify HLA molecular subtype positive and tumor antigen target(s) positive patients who may be eligible for enrollment into Immatics clinical studies. This screening study is intended for patients with advanced and/or metastatic solid cancers. No treatment intervention will occur as part of this screening study.
Detailed description
The purpose of this screening study is to identify human leukocyte antigen (HLA) molecular subtype positive and tumor antigen target(s) positive patients. No treatment intervention will occur as part of this screening study.
After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA molecular subtype positivity. Patients that are HLA molecular subtype positive are then assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh tumor tissue obtained by a biopsy for this screening study will be required. If the patient is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be collected during the procedure to avoid the patient being subjected to another biopsy.
Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic (IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker analyses and validation studies for regulatory approval.
Immatics is conducting clinical studies which target patients with advanced and/or metastatic solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies of adoptive cell therapy (ACT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed advanced and/or metastatic solid tumors
Key inclusion criteria (18 listed)
- Signed an Informed Consent Form (ICF)
- Patients ≥ 18 years of age
- Patients with confirmed advanced and/or metastatic solid tumors.
- For liver cancer patients, the diagnosis must be confirmed
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 0-1
Key exclusion criteria (17 listed)
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
- Patients with primary central nervous system (CNS)/brain tumors
- Patients whose tumors have very low expression of tumor antigen targets such as kidney chromophobe, thyroid carcinoma, and prostate adenocarcinoma
- Patients who are pregnant or are breastfeeding
- Patients with serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents
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 patients with protocol-specified HLA subtype
Time frame: 3 years
Frequency of patients with expression of analyzed tumor antigen targets
Time frame: 3 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 Feb 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.
Cedrik Britten, M.D. study director
Immatics US
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Cancer and Recurrent Cancer, run by Immatics US, Inc. at 4 sites in United States.
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 18 inclusion and 17 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 patients with protocol-specified HLA subtype (time frame: 3 years). The study lists 2 primary outcomes in all. 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 Feb 2025.