Solid TumorPhase 1UVA-AM-001NCT02987166

HDCRT Plus Pembrolizumab in Advanced Malignancies

A Phase 1 study testing High-Dose Conformal Radiation Therapy and Pembrolizumab in people with Solid Tumor, run by James Larner, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT) administered in combination with pembrolizumab in patients with solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: High-Dose Conformal Radiation Therapy and Pembrolizumab
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 21 Mar 2017to 10 Feb 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Subjects must have a histologically or cytologically proven advanced solid tumor malignancy for which palliative radiation is recommended. In solid tumors where pembrolizumab has been approved for use, patients may receive pembrolizumab as indicated, in the context of this protocol. In solid tumors where pembrolizumab has not been approved for use, the following criteria apply:
Patients must be resistant to at least 1 prior conventional chemotherapy regimen or other standard of care regimen,
Patient must have no remaining conventional treatment options proven to provide long-term disease control, and
Patient has declined other conventional treatment options
Palliative radiation therapy may be recommended for primary tumor and/or any metastatic site that is accessible to biopsy.
At least one site of disease that is accessible to radiation and multiple biopsies. Subjects may have disease that is encompassed within the radiation field or may have known disease both inside and outside of the radiation field.

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Must be able to provide tissue from 2-3 separate biopsy procedures that will be completed throughout the course of the study.
A performance status of 0, 1 or 2 on the ECOG Performance Scale.
Subjects must demonstrate adequate organ function.
A life expectancy ≥ 6 months.

Who cannot join

Requires urgent treatment with cytotoxic chemotherapy or other therapy is indicated.
A diagnosis of immunodeficiency.
A known history of active TB (Bacillus Tuberculosis).
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with untreated brain metastases and patients who have had brain metastases re-treated with radiation will be excluded. Patients whom have either midline shift, or any signs of herniation (even if disease has been treated with GK) will be excluded. Subjects with previously treated brain metastases may participate provided they are 1) stable (without clinical evidence of progression) 2) are out at least 10 days from CNS radiation and 3) and are not using steroids as part of treatment for their brain lesions for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Active autoimmune disease that has required systemic treatment in the past 2 years.
A history of (non-infectious) pneumonitis that required steroids or current pneumonitis.

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An infection requiring systemic therapy.
Pregnancy.
HIV positivity.
Evidence of active Hepatitis B virus or Hepatitis C virus.
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, uncontrolled arrhythmias, or severe valvular heart disease, or a myocardial infarction within 6 months prior to the first dose of study treatment.
Active bleeding disorders or evidence of chronic or acute disseminated intravascular coagulation (DIC).
Class III or IV heart disease (New York Heart Association classification).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: A Pilot Study to Assess the Combination of High-Dose Conformal Radiation Therapy (HDCRT) and Pembrolizumab in Modulating Local and Systemic T-cell Responses in Advanced Malignancies

This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT) administered in combination with pembrolizumab in patients with solid tumors.

Conditions: Solid Tumor
Being tested: High-Dose Conformal Radiation Therapy, Pembrolizumab
Keywords: immunotherapy, pembrolizumab, MK-3475, High-dose conformal radiation therapy, HDCRT, advanced solid tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High-Dose Conformal Radiation TherapyRadiation
Also called HDCRT
24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
PembrolizumabDrug
Also called Keytruda, MK-3475
200 mg

Study groups in NCT02987166
Study group	Role	What they receive
Arm A: HDCRT administered with first dose of pembrolizumab	Experimental	Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1. Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years. HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1. Receives: Radiation: High-Dose Conformal Radiation Therapy; Drug: Pembrolizumab
Arm B: HDCRT administered between doses 1& 2 of pembrolizumab	Experimental	Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22. Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years. HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22. Receives: Radiation: High-Dose Conformal Radiation Therapy; Drug: Pembrolizumab
Arm C: HDCRT administered prior to first dose of pembrolizumab	Experimental	Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1. Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years. HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1. Receives: Radiation: High-Dose Conformal Radiation Therapy; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: Adverse Event Profile
Adverse events related to HDCRT with immunotherapy, delivered concurrently (Arm A) or sequentially (Arms B and C)
Measured: up to 24 months for adverse events; up to 27 months for serious adverse events
Enumeration of T Cells in Tumor Tissue
Log-normalized enumeration of CD8+ T cells and FoxP3+ cells in untreated and treated tumor tissue by immunohistochemical analysis to estimate group differences and changes over time in immune assay parameters in tumor.
Measured: At Baseline, Day 22 of treatment, and Day 43 or treatment

Secondary outcomes (1)

Enumeration of Circulating Immune Cells
Enumeration of CD8+ and CD4+ T cells in untreated and treated blood samples to estimate group differences and changes over time in immune assay parameters in PBMC
Measured: at Baseline and at Days 22 , 43, 64, and 85 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201710 Feb 2020

First posted8 Dec 2016 (estimated)
Study start21 Mar 2017
Primary completion13 Jan 2020
Study completion10 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Solid TumorStudies 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: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02987166
Sponsor's protocol ID: 18488
Acronym: UVA-AM-001
Status last verified: May 2026
First submitted: 30 Nov 2016
Last updated: 15 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Assess the Combination of High-Dose Conformal Radiation Therapy (HDCRT) and Pembrolizumab in Modulating Local and Systemic T-cell Responses in Advanced Malignancies
ClinicalTrials.gov ID: NCT02987166
Acronym / sponsor ID: UVA-AM-001 / 18488
Conditions: Solid Tumor
Keywords: immunotherapy, pembrolizumab, MK-3475, High-dose conformal radiation therapy, HDCRT, advanced solid tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: James Larner, MDUniversity, hospital or other
Study start: 21 Mar 2017 (actual)
Primary completion: 13 Jan 2020 (actual)
Study completion: 10 Feb 2020 (actual)
First posted: 8 Dec 2016 (estimated)
Results: Posted 15 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT) administered in combination with pembrolizumab in patients with solid tumors.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm A: HDCRT administered with first dose of pembrolizumab	Experimental	Radiation: High-Dose Conformal Radiation Therapy, Drug: PembrolizumabPembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1. Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years. HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
Arm B: HDCRT administered between doses 1& 2 of pembrolizumab	Experimental	Radiation: High-Dose Conformal Radiation Therapy, Drug: PembrolizumabPembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22. Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years. HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
Arm C: HDCRT administered prior to first dose of pembrolizumab	Experimental	Radiation: High-Dose Conformal Radiation Therapy, Drug: PembrolizumabPembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1. Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years. HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects must have a histologically or cytologically proven advanced solid tumor malignancy for which palliative radiation is recommended. In solid tumors where pembrolizumab has been approved for use, patients may receive pembrolizumab as indicated, in the context of this protocol. In solid tumors where pembrolizumab has not been approved for use, the following criteria apply:
Palliative radiation therapy may be recommended for primary tumor and/or any metastatic site that is accessible to biopsy.
At least one site of disease that is accessible to radiation and multiple biopsies. Subjects may have disease that is encompassed within the radiation field or may have known disease both inside and outside of the radiation field.
Must be able to provide tissue from 2-3 separate biopsy procedures that will be completed throughout the course of the study.
A performance status of 0, 1 or 2 on the ECOG Performance Scale.

Key exclusion criteria (13 listed)

Requires urgent treatment with cytotoxic chemotherapy or other therapy is indicated.
A diagnosis of immunodeficiency.
A known history of active TB (Bacillus Tuberculosis).
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with untreated brain metastases and patients who have had brain metastases re-treated with radiation will be excluded. Patients whom have either midline shift, or any signs of herniation (even if disease has been treated with GK) will be excluded. Subjects with previously treated brain metastases may participate provided they are 1) stable (without clinical evidence of progression) 2) are out at least 10 days from CNS radiation and 3) and are not using steroids as part of treatment for their brain lesions for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Active autoimmune disease that has required systemic treatment in the past 2 years.

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
High-Dose Conformal Radiation TherapyAlso: HDCRT24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions 30 Gy in 5 fractions of 6 Gy each for prostate gland	Radiation	Arm A: HDCRT administered with first dose of pembrolizumab, Arm B: HDCRT administered between doses 1& 2 of pembrolizumab, Arm C: HDCRT administered prior to first dose of pembrolizumab
PembrolizumabAlso: Keytruda, MK-3475200 mg	Drug	Arm A: HDCRT administered with first dose of pembrolizumab, Arm B: HDCRT administered between doses 1& 2 of pembrolizumab, Arm C: HDCRT administered prior to first dose of pembrolizumab

Primary outcome

Safety: Adverse Event Profile
Time frame: up to 24 months for adverse events; up to 27 months for serious adverse events
Adverse events related to HDCRT with immunotherapy, delivered concurrently (Arm A) or sequentially (Arms B and C)
Enumeration of T Cells in Tumor Tissue
Time frame: At Baseline, Day 22 of treatment, and Day 43 or treatment
Log-normalized enumeration of CD8+ T cells and FoxP3+ cells in untreated and treated tumor tissue by immunohistochemical analysis to estimate group differences and changes over time in immune assay parameters in tumor.

1 secondary outcome

Enumeration of Circulating Immune Cells
Time frame: at Baseline and at Days 22 , 43, 64, and 85 of treatment

Results and safety

Results posted to the registry on 15 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: HDCRT Administered With First Dose of Pembrolizumab	7	7
Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab	6	6
Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab	8	8

Primary outcome: Safety: Adverse Event Profile

Time frame: up to 24 months for adverse events; up to 27 months for serious adverse events. Count of units. Unit: Number of Adverse Events

Measure	ARM A Grade 1 n = 7	ARM A Grade 2 n = 7	ARM A Grade 4 n = 7	ARM B Grade 1 n = 6	ARM B Grade 3 n = 6	ARM C Grade 1 n = 8	ARM C Grade 2 n = 8	ARM C Grade 3 n = 8	ARM C Grade 4 n = 8	ARM C Grade 5 n = 8
Anemia	0	0	–	1	0	1	1	1	–	–
Other Blood Lymphatic	0	0	–	0	0	1	0	0	–	–
Hyperthyroidism	0	0	–	1	0	0	0	0	–	–
Hypothyroidism	0	0	–	1	0	0	1	0	–	–
Nausea	2	0	–	1	0	1	0	0	–	–
Vomiting	0	0	–	0	0	1	0	0	–	–
Fatigue	0	1	–	2	1	2	1	0	–	–
Fever	0	1	–	0	0	0	0	0	–	–

Population analysed: The units analyzed are the number of adverse events experienced per arm.

Primary outcome: Enumeration of T Cells in Tumor Tissue

Time frame: At Baseline, Day 22 of treatment, and Day 43 or treatment. Mean (Standard Deviation). Unit: log(cells/ mm^2 of biopsy)

Measure	Arm A: HDCRT Administered With First Dose of Pembrolizumab n = 4	Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab n = 5	Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab n = 5
CD8+ Baseline	1.69 (0.49)	1.84 (0.5)	1.61 (0.89)
FoxP3 Baseline	0.89 (0.59)	0.88 (0.55)	1.13 (0.57)
CD8+ Day 22	1.55 (0.8)	2.11 (0.42)	1.93 (0.44)
FoxP3 Day 22	1.59 (0.09)	1.78 (0.7)	1.4 (0.61)
CD8+ Day 43	1.92 (0.58)	1.89 (0.69)	1.71 (0.78)
FoxP3 Day 43	1.53 (0.25)	1.26 (0.67)	1.3 (0.63)

Population analysed: 14 out of the 21 subjects completed all 3 protocol required tumor biopsy and were evaluable for immunological analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 24 months for adverse events; up to 27 months for serious adverse events. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: HDCRT Administered With First Dose of Pembrolizumab	2 of 7 (28.6%)	7 of 7 (100%)	3 of 7
Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab	1 of 6 (16.7%)	6 of 6 (100%)	1 of 6
Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab	2 of 8 (25%)	8 of 8 (100%)	3 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

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RecruitingPhase 1/2
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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.

James Larner, MD principal investigator

University of Virginia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing High-Dose Conformal Radiation Therapy and Pembrolizumab in people with Solid Tumor, run by James Larner, MD 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 10 inclusion and 13 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 15 Jun 2026. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety: Adverse Event Profile (time frame: up to 24 months for adverse events; up to 27 months for serious adverse events). 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?

On the ClinicalTrials.gov record for NCT02987166.

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 15 Jun 2026.