Unspecified Adult Solid Tumor, Protocol SpecificNCT02153151
Measuring Biomarker Response to AMP-514 in Blood Samples From Patients With Solid Tumors Undergoing Radiotherapy
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This pilot research trial studies the response in blood cells to AMP-514, a drug shown to increase immune response (capacity to fight against infections and cancer) against cancer in patients with solid tumors undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Cytology specimen and Laboratory biomarker analysis
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2013to 14 Jul 2016
- 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 diagnosed with solid malignancies to be treated with RT
Who may be able to join
- Patients 18 years of age or older
- Histological diagnosis of any solid malignancies and candidates to be treated with RT (with or without chemotherapy). Patients who have synchronous primary solid malignancies are eligible. When the risks associated with the diagnostic procedure are very high, due to different clinical reasons (e.g., severe chronic obstructive lung disease [COPD] when a CT-guided biopsy is associated with a very high risk of pneumothorax), and a biopsy is not feasible, then the patient may be enrolled to the study as per PI judgment.
- ECOG performance status score of 0-3.
- Life expectancy of 3 months or longer.
- Patients able to provide a written informed consent prior to study entry.
Who cannot join
- Patients with contraindication to RT.
- Major surgery within 1 month of starting the study treatment.
- Prior chemotherapy or radiotherapy for their solid malignancies.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection.
- Active infection with hepatitis B or hepatitis C (blood testing is not required for purpose of eligibility).
- Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated basal or squamous cell carcinoma of skin, superficial bladder cancer or carcinoma in situ of cervix, AJCC (version 7.0) stage 0 or I breast cancer, AJCC (version 7.0) stage I, or II prostate cancer.
- Patients are excluded if they have a history of autoimmune disease, as follows: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis) are excluded. Patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy.
- Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study to Evaluate the In-vitro Effect of AMP-514, a PD-1 Inhibitor, on Peripheral Blood T Cell Proliferation and Cytokine Production From Patients With Solid Malignancies Treated With Radiotherapy (RT)
This pilot research trial studies the response in blood cells to AMP-514, a drug shown to increase immune response (capacity to fight against infections and cancer) against cancer in patients with solid tumors undergoing radiotherapy. Measuring changes in biomarkers may help doctors decide if AMP-514 should be combined with radiotherapy and when is the best time to combine the drug with radiation.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the in-vitro effect of AMP-514, a programmed cell death 1 (PD-1) inhibitor, on peripheral blood T cell proliferation and cytokine production from patients with solid malignancies, treated with radiotherapy (RT).
OUTLINE:
Patients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT.
- Being tested
- Cytology specimen, Laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology specimenOther
Also called Cytologic sampling
Correlative studies
Laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| In vitro effect of AMP-514 | Patients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT Receives: Other: Cytology specimen; Other: Laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral blood T cell proliferation (stimulation) and cytokine production in vitro
Mixed effects linear regression used to model each marker. Markers measured under treated and control conditions at 4 time points. Saturated fixed effects model including fixed effects for treatment condition, evaluation time \& condition by time interaction used. Repeated measures covariance structure that accounts for correlation between treated \& control samples at each time \& correlation among repeated samples from the 4 measurement periods assumed. Overall effect of treatment as well as time-specific estimates of treatment effect estimated along with appropriate 95% confidence intervals.
Measured: Baseline to up to 1 month after the end of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study start11 Nov 2013
- Primary completion23 Feb 2016
- Study completion14 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Voichita Bar-Ad, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153151
- Sponsor's protocol ID
- 13D.374
- Other IDs
- 2013-021, JT 2609
- Status last verified
- May 2025
- First submitted
- 29 May 2014
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the In-vitro Effect of AMP-514, a PD-1 Inhibitor, on Peripheral Blood T Cell Proliferation and Cytokine Production From Patients With Solid Malignancies Treated With Radiotherapy (RT)
- ClinicalTrials.gov ID
- NCT02153151
- Acronym / sponsor ID
- 13D.374
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 23 Feb 2016 (actual)
- Study completion
- 14 Jul 2016 (actual)
- First posted
- 2 Jun 2014 (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 pilot research trial studies the response in blood cells to AMP-514, a drug shown to increase immune response (capacity to fight against infections and cancer) against cancer in patients with solid tumors undergoing radiotherapy. Measuring changes in biomarkers may help doctors decide if AMP-514 should be combined with radiotherapy and when is the best time to combine the drug with radiation.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the in-vitro effect of AMP-514, a programmed cell death 1 (PD-1) inhibitor, on peripheral blood T cell proliferation and cytokine production from patients with solid malignancies, treated with radiotherapy (RT).
OUTLINE:
Patients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In vitro effect of AMP-514 | – | Other: Cytology specimen, Other: Laboratory biomarker analysisPatients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with solid malignancies to be treated with RT
Key inclusion criteria (5 listed)
- Patients 18 years of age or older
- Histological diagnosis of any solid malignancies and candidates to be treated with RT (with or without chemotherapy). Patients who have synchronous primary solid malignancies are eligible. When the risks associated with the diagnostic procedure are very high, due to different clinical reasons (e.g., severe chronic obstructive lung disease [COPD] when a CT-guided biopsy is associated with a very high risk of pneumothorax), and a biopsy is not feasible, then the patient may be enrolled to the study as per PI judgment.
- ECOG performance status score of 0-3.
- Life expectancy of 3 months or longer.
- Patients able to provide a written informed consent prior to study entry.
Key exclusion criteria (8 listed)
- Patients with contraindication to RT.
- Major surgery within 1 month of starting the study treatment.
- Prior chemotherapy or radiotherapy for their solid malignancies.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection.
- Active infection with hepatitis B or hepatitis C (blood testing is not required for purpose of eligibility).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology specimenAlso: Cytologic samplingCorrelative studies | Other | In vitro effect of AMP-514 |
| Laboratory biomarker analysisCorrelative studies | Other | In vitro effect of AMP-514 |
Primary outcome
Change in peripheral blood T cell proliferation (stimulation) and cytokine production in vitro
Time frame: Baseline to up to 1 month after the end of RT
Mixed effects linear regression used to model each marker. Markers measured under treated and control conditions at 4 time points. Saturated fixed effects model including fixed effects for treatment condition, evaluation time \& condition by time interaction used. Repeated measures covariance structure that accounts for correlation between treated \& control samples at each time \& correlation among repeated samples from the 4 measurement periods assumed. Overall effect of treatment as well as time-specific estimates of treatment effect estimated along with appropriate 95% confidence intervals.
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 2 May 2025.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalsLink provided by the sponsor.
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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.
Voichita Bar-Ad, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site 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 5 inclusion and 8 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in peripheral blood T cell proliferation (stimulation) and cytokine production in vitro (time frame: Baseline to up to 1 month after the end of RT). 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 2 May 2025.