Hematopoietic and Lymphoid Cell NeoplasmPhase 2NCT02710253

Salvage Radiation Therapy in Treating Patients With Metastatic Cancer That Has Progressed After Systemic Immunotherapy

A Phase 2 study testing External Beam Radiation Therapy, Laboratory Biomarker Analysis and Stereotactic Body Radiation Therapy in people with Hematopoietic and Lymphoid Cell Neoplasm and Metastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 5 sites 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm
What is being tested?: External Beam Radiation Therapy, Laboratory Biomarker Analysis and Stereotactic Body Radiation Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 5 sitesUnited States
Study dates: 25 May 2016to 24 Jun 2026
Phase: Phase 2
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

Who may be able to join

Pathologically confirmed diagnosis of cancer.
Progressive disease via irRC on prior study or standard of care therapy utilizing an immunotherapy agent OR a clinical status that requires salvage radiation treatment (e.g.: palliative RT) at the discretion of treating Physician and/or PI.
Previous progression of disease while on treatment of an immunotherapy agent or cell-based therapy.
Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation.
Have at least one site of metastatic disease amenable to radiation. All lesions amenable to radiation may be irradiated at the discretion of treating Radiation Oncologist, depending on the location, size and number of lesions.
Be willing and able to provide written informed consent-for the trial.

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Be ≥ 18 years of age on day of signing informed consent.
Have a performance status of 0-2 on the ECOG performance scale.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 28 days prior to first fraction of radiation.
Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
We will allow prior radiation to other sites, with no washout period, prior to study entry as long as the high dose regions of the prior and proposed radiation fields do not overlap or it can overlap, as long as the area being treated is getting low dose radiation; this can be done alone or in combination with high dose to a previously un-irradiated area.
Non-English speakers may enroll on the protocol.

Who cannot join

The subject must be excluded from participating in the trial if the subject:
Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
Has had prior radiation therapy within the past 3 months where the high dose area of the prior radiation would overlap with the high dose area of the intended radiation based on the judgment of the treating radiation oncologist.
Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previous treatment.
Note: Subjects with permanent ≤ Grade 2 toxicities (e.g. neuropathy) or toxicities corrected through routine medical management (e.g. thyroid replacement for hypothyroidisim) are an exception to this criterion and may qualify for the study.
Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

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Note: Subjects with asymptomatic ≤ Grade 2 laboratory or dermatologic abnormalities are an exception to this criterion and may qualify for the study pending the judgment of the treating radiation oncologist.
Has an active infection requiring intravenous systemic therapy or hospital admission.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or expecting to conceive or within the projected duration of the trial, starting with the screening visit through 60 days after the last fraction of radiation.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

MD Anderson in The Woodlands
Conroe, Texas, 77384
M D Anderson Cancer Center
Houston, Texas, 77030
MD Anderson West Houston
Houston, Texas, 77079
MD Anderson League City
League City, Texas, 77573
MD Anderson in Sugar Land
Sugar Land, Texas, 77478

Other trials in United States

About this study

Official title: Phase II Trial of Salvage Radiation Therapy to Induce Systemic Disease Regression After Progression on Systemic Immunotherapy

This phase II trial studies the side effects and best dose of radiation therapy and to see how well it works in treating patients with cancer that has spread to other places in the body (metastatic) or has increased in size after being treated with immunotherapy. Giving radiation therapy may help to control the cancer after the disease has gotten worse after receiving immunotherapy in patients with cancer that has spread to the other places in the body.

Read the detailed description

PRIMARY OBJECTIVES:

To identify immunotherapy-based treatments where salvage radiation produces systemic disease control after initial progressive disease.

II. To identify immunotherapy-based treatments where salvage radiation produces a high rate of treatment-related toxicities.

SECONDARY OBJECTIVES:

To determine the frequency of systemic disease control (objective response or stable disease) after salvage radiation following progression on immunotherapy among all patients and within each treatment group.

II. Determine the frequency of dose limiting toxicities (DLTs) with salvage radiation after progression on treatment with an immunotherapy agent among all patients and within each treatment group.

III. To determine the rate of systemic objective response among all patients and within each treatment group among all patients and within each treatment group.

IV. To determine the duration of response in patients who achieve disease control among all patients and within each treatment group.

To determine the overall survival after salvage radiation among all patients and within each treatment group.

VI. To determine the systemic progression free survival after salvage radiation among all patients and within each treatment group.

OUTLINE:

Patients undergo either 4, 5, or 10 fractions of stereotactic body radiation therapy (SBRT), or 5-15 fractions of external beam radiation therapy (EBRT) to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least stable disease (SD) after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions.

After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 1 year.

Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm
Being tested: External Beam Radiation Therapy, Laboratory Biomarker Analysis, Stereotactic Body Radiation Therapy
Medical subject headings: Hematologic Neoplasms, Neoplasm Metastasis

What participants receive

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

External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy
Undergo EBRT
Laboratory Biomarker AnalysisOther
Correlative studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT

Study groups in NCT02710253
Study group	Role	What they receive
Treatment (SBRT or EBRT)	Experimental	Patients undergo either 4, 5, or 10 fractions of SBRT, or 5-15 fractions of EBRT to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least SD after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions. Receives: Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis; Radiation: Stereotactic Body Radiation Therapy

What is being measured

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

Number of patients with stable disease
To be evaluable for efficacy patients must receive at least one set of systemic imaging >= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing immune-related response criteria (ir-RC). Significance testing will assess differences in the frequency of disease control rate via Fisher Exact (if n =< 20) or Chi-squared (if n > 20) test.
Measured: At 4 months
Objective response (partial response or complete response)
To be evaluable for efficacy patients must receive at least one set of systemic imaging >= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing ir-RC. Significance testing will assess differences in the frequency of objective response via Fisher exact (if n =< 20) or Chi-squared (if n > 20) test.
Measured: Up to 1 year
Incidence of adverse events
Assessed with Common Terminology Criteria for Adverse Events version 4.0. To be evaluable for toxicity, patients must be on the trial for at least 8 weeks. For a toxicity to be considered a dose limiting toxicity, the toxicity must be grade 3+ non-dermatologic and non-laboratory, grade 4+ laboratory, or grade 4+ dermatologic. In addition the toxicity must meet the following criteria:
1. The toxicity must be immune-related.
2. The toxicity must be attributable to radiation. Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Significance testing will assess differences in dose limiting toxicities via Fisher Exact (if n =< 20) or Chi-Squared (if n > 20) test.
Measured: Up to 1 year

Secondary outcomes (2)

Overall survival
Will be calculated utilizing the method of Kaplan and Meier. Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Differences in overall survival will be compared utilizing Log-Rank test and Cox proportional hazards regression adjusting for factors including treatment group, disease histology, previous response with the most recent immunotherapy based treatment.
Measured: Up to 1 year
Progression free survival
Will be calculated via RECIST 1.1 utilizing the method of Kaplan and Meier. Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Differences in progression free survival will be compared utilizing Log-Rank test and Cox proportional hazards regression adjusting for factors including treatment group, disease histology, previous response with the most recent immunotherapy based treatment.
Measured: Up to 1 year

Timeline

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

25 May 201624 Jun 2026

First posted16 Mar 2016 (estimated)
Study start25 May 2016
Primary completion24 Jun 2026
Study completion24 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02710253
Sponsor's protocol ID: 2015-0936
Other IDs: NCI-2016-00682, 2015-0936
Status last verified: Jul 2026
First submitted: 11 Mar 2016
Last updated: 7 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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

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All Hematopoietic and Lymphoid Cell Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Salvage Radiation Therapy to Induce Systemic Disease Regression After Progression on Systemic Immunotherapy
ClinicalTrials.gov ID: NCT02710253
Acronym / sponsor ID: 2015-0936
Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 214 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: Artidis
Study start: 25 May 2016 (actual)
Primary completion: 24 Jun 2026 (actual)
Study completion: 24 Jun 2026 (actual)
First posted: 16 Mar 2016 (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.

Detailed description

PRIMARY OBJECTIVES:

To identify immunotherapy-based treatments where salvage radiation produces systemic disease control after initial progressive disease.

II. To identify immunotherapy-based treatments where salvage radiation produces a high rate of treatment-related toxicities.

SECONDARY OBJECTIVES:

To determine the frequency of systemic disease control (objective response or stable disease) after salvage radiation following progression on immunotherapy among all patients and within each treatment group.

II. Determine the frequency of dose limiting toxicities (DLTs) with salvage radiation after progression on treatment with an immunotherapy agent among all patients and within each treatment group.

III. To determine the rate of systemic objective response among all patients and within each treatment group among all patients and within each treatment group.

IV. To determine the duration of response in patients who achieve disease control among all patients and within each treatment group.

To determine the overall survival after salvage radiation among all patients and within each treatment group.

VI. To determine the systemic progression free survival after salvage radiation among all patients and within each treatment group.

OUTLINE:

After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 1 year.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (SBRT or EBRT)	Experimental	Radiation: External Beam Radiation Therapy, Other: Laboratory Biomarker Analysis, Radiation: Stereotactic Body Radiation TherapyPatients undergo either 4, 5, or 10 fractions of SBRT, or 5-15 fractions of EBRT to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least SD after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions.

Who may qualify

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

Key inclusion criteria (12 listed)

Pathologically confirmed diagnosis of cancer.
Progressive disease via irRC on prior study or standard of care therapy utilizing an immunotherapy agent OR a clinical status that requires salvage radiation treatment (e.g.: palliative RT) at the discretion of treating Physician and/or PI.
Previous progression of disease while on treatment of an immunotherapy agent or cell-based therapy.
Have at least one site of metastatic disease amenable to radiation. All lesions amenable to radiation may be irradiated at the discretion of treating Radiation Oncologist, depending on the location, size and number of lesions.
Be willing and able to provide written informed consent-for the trial.

Key exclusion criteria (10 listed)

Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
Has had prior radiation therapy within the past 3 months where the high dose area of the prior radiation would overlap with the high dose area of the intended radiation based on the judgment of the treating radiation oncologist.
Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previous treatment.
Has an active infection requiring intravenous systemic therapy or hospital admission.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

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
External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam RadiotherapyUndergo EBRT	Radiation	Treatment (SBRT or EBRT)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (SBRT or EBRT)
Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT	Radiation	Treatment (SBRT or EBRT)

Primary outcome

Number of patients with stable disease
Time frame: At 4 months
To be evaluable for efficacy patients must receive at least one set of systemic imaging >= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing immune-related response criteria (ir-RC). Significance testing will assess differences in the frequency of disease control rate via Fisher Exact (if n =< 20) or Chi-squared (if n > 20) test.
Objective response (partial response or complete response)
Time frame: Up to 1 year
To be evaluable for efficacy patients must receive at least one set of systemic imaging >= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing ir-RC. Significance testing will assess differences in the frequency of objective response via Fisher exact (if n =< 20) or Chi-squared (if n > 20) test.
Incidence of adverse events
Time frame: Up to 1 year
Assessed with Common Terminology Criteria for Adverse Events version 4.0. To be evaluable for toxicity, patients must be on the trial for at least 8 weeks. For a toxicity to be considered a dose limiting toxicity, the toxicity must be grade 3+ non-dermatologic and non-laboratory, grade 4+ laboratory, or grade 4+ dermatologic. In addition the toxicity must meet the following criteria: 1. The toxicity must be immune-related. 2. The toxicity must be attributable to radiation. Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Significance testing will assess differences in dose limiting toxicities via Fisher Exact (if n =< 20) or Chi-Squared (if n > 20) test.

2 secondary outcomes

Overall survival
Time frame: Up to 1 year
Progression free survival
Time frame: Up to 1 year

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 7 Jul 2026.
MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Hematopoietic and Lymphoid Cell Neoplasm

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Hematologic Cancer, MACE
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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Active, not recruitingPhase 1
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Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
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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 Welsh principal investigator

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 10 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

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?

Number of patients with stable disease (time frame: At 4 months). The study lists 3 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 NCT02710253.

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 7 Jul 2026.