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Radiation and immunotherapy combo shows promise in small cancer study

NCT ID NCT02987166

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether combining high-dose radiation therapy with the immunotherapy drug pembrolizumab (Keytruda) could boost the immune system's ability to fight advanced solid tumors. Twenty-one patients with various advanced cancers received the combination either at the same time or one after the other. The main goals were to check safety and measure changes in immune cells in tumors and blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab (Keytruda) and high-dose conformal radiation therapy
What this could lead to
If successful, this approach could improve how well immunotherapy works against advanced solid tumors by using radiation to help the immune system attack cancer cells throughout the body.
What could go wrong
This was a very small, early-phase pilot study (21 people) focused on safety and immune markers, not on curing cancer. The combination may cause side effects and may not shrink tumors or extend survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Mar 2017

Finished

Feb 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.