AzTrials
AzTrials

Sarcoma, Soft TissueEarly Phase 1NCT05488366

Immunotherapy Combined With Radiotherapy for Metastatic Sarcoma

A Early Phase 1 study testing Pembrolizumab and Radiation therapy in people with Sarcoma, Soft Tissue, run by University of California, Irvine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a pilot study determining the feasibility of combination treatments, pembrolizumab and stereotactic ablative radiotherapy (SBRT) in subjects with soft-tissue sarcoma. These are subjects who have metastatic disease initially, or recurrent or progressive disease that is not eligible for curative surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
Pembrolizumab and Radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
3 Aug 2022to Nov 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • Patients must have histologically or cytologically confirmed soft-tissue sarcoma, or a soft-tissue sarcoma with tumor mutational burden ≥10 mut/Mb.
  • Patient must either have started a checkpoint inhibitor immunotherapy regimen within 60 days, or have a soft-tissue sarcoma histology amenable to pembrolizumab therapy (inclusive of undifferentiated pleomorphic sarcoma [formerly known as malignant fibrous histiocytoma], myxofibrosarcoma, dedifferentiated liposarcoma or undifferentiated sarcoma [unclassified histology]).
  • Patients with soft-tissue sarcoma must have advanced disease (stage IV) or previously treated disease that has become progressive, recurrent, or metastatic, and either previously received first-line systemic therapy or been deemed ineligible to receive first-line systemic therapy. Staging is by AJCC 8th Edition.
  • Must not have disease amenable to curative intent surgery.
  • Must have at least 2 measurable lesions per RECIST v1.1 assessed by CT scan. A measurable lesion is defined to mean at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
  • Must have at least 1 site of non-central nervous system (CNS) disease amenable to treatment with radiation therapy. This lesion may have been previously treated with radiation if the cumulative spinal cord dose will remain below a Biologically Effective Dose (BED)α/β 2Gy of 112 Gy (single fraction equivalent 14 Gy) and the radiation will be delivered at least 180 days after completion of the prior radiation course to the same site. BED will be calculated using the linear-quadratic formula: d * f * (1 + [d / (α/β)]), where d is the dose per fraction, f is the total number of fractions, and α/β is the property of irradiated tissue measured in Gray.
Show all 28Show fewer
  • Must be age ≥ 18 years. Because initial and subsequent therapies for pediatric sarcomas (<18 years of age) are different than those ≥18, children are excluded from this study. In addition, because no adverse event data are currently available on the use of SBRT combined with pembrolizumab in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
  • 1. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial
  • Performance status: ECOG performance status ≤2 (Karnofsky ≥50%).
  • Life expectancy of ≥3 months.
  • Adequate organ and marrow function as defined below. Labs should be performed within 14 days of treatment.
  • Leukocytes ≥2,000/mcL
  • Absolute neutrophil count ≥1,000/mcL
  • Platelets ≥75,000/mcL
  • AST(SGOT)/ALT(SPGT) ≤3 times institutional upper limit of normal (ULN), or ≤5 times ULN for patients with liver metastases
  • Total bilirubin ≤2.5 times institutional ULN
  • Serum creatinine ≤2.5 times institutional ULN, or calculated creatinine clearance ≥30 mL/min (if serum creatinine >2.5 times institutional ULN)
  • Thyroid stimulating hormone within institutional limits, or T4 is within institutional limits if TSH is outside of institutional limits
  • Female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours before receiving the first dose of pembrolizumab. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • The effects of pembrolizumab and ionizing radiation on the developing human fetus are known to have the potential for congenital abnormalities and fetal harm. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 120 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • 1. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Patients who are HIV-positive with undetectable HIV viral load are eligible provided they meet all other protocol criteria for participation.
  • Patients with HBV or HCV infection are eligible provided viral loads are undetectable. Patients on suppressive therapy are eligible.
  • Patients must not be on active immunosuppression within 7 days prior to the first dose of treatment.
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Ability to understand and willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 2 weeks prior to initiation of study therapy.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy administered.
  • Patients must not be receiving any other investigational agents.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Show all 12Show fewer
  • Pembrolizumab can cause fetal harm when administered to a pregnant woman based on the biological mechanism that PD-1/PD-L1 signaling is an important pathway in the maintenance of pregnancy through induction of maternal immune tolerance to fetal tissue.1 Human IgG4 is known to cross the placenta. Animal models have found that blocking PD-L1 signaling increases the risk of fetal loss, and immune-mediated disorders occurred in PD-1 knockout mice.
  • Although there are not data on the presence of pembrolizumab in either animal or human milk or its effects on breastfed children or on milk production, there is a potential for serious adverse reactions in breastfed children. Thus, women are advised not to breastfeed during treatment with pembrolizumab and for 120 days after the final dose.
  • Patients with disease amenable to curative intent surgery.
  • Patient has had a prior monoclonal antibody for treatment of sarcoma, unless the current regimen is checkpoint inhibitor immunotherapy.
  • Patient has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin.
  • Patient has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with resolved childhood asthma, hypothyroidism stable on hormone replacement, Sjogren's syndrome, or with vitiligo would not be excluded. Patients requiring intermittent bronchodilators, inhaled steroids, or local steroid injections would not be excluded. Patients requiring physiologic doses of corticosteroids may be approved after consultation with the protocol principal investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868

Other trials in United States

About this study

Official title: A Pilot Study of Immunotherapy Combined With Stereotactic Ablative Radiotherapy for Patients With Advanced or Metastatic Sarcoma

This is a pilot study determining the feasibility of combination treatments, pembrolizumab and stereotactic ablative radiotherapy (SBRT) in subjects with soft-tissue sarcoma. These are subjects who have metastatic disease initially, or recurrent or progressive disease that is not eligible for curative surgery.

Being tested
Pembrolizumab, Radiation therapy
Keywords
Sarcoma, Advanced Sarcoma, Metastatic Sarcoma, Pembrolizumab, Stereotactic Ablative Radiotherapy
Medical subject headings
Sarcoma

What participants receive

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

  • PembrolizumabDrug

    Also called MK-3475

    Given IV

  • Radiation therapyRadiation

    Also called RT

    Single target will be selected by the treating radiation oncologist. A lesion causing symptoms or expected to become symptomatic will be favored for target selection.

Study groups in NCT05488366
Study groupRoleWhat they receive
A: Pembrolizumab + Radiation TherapyExperimentalPatients receive pembrolizumab 400 mg intravenous every 42 days; Radiation therapy in 1 to 10 fractions.
Receives: Drug: Pembrolizumab; Radiation: Radiation therapy
B: Radiation Therapy with or without standard of care checkpoint inhibitor immunotherapyExperimentalPatients who are currently receiving a checkpoint inhibitor immunotherapy regimen will be allowed to continue their regimen at their treating oncologist's discretion. Radiation therapy will be delivered in 1 to 10 fractions starting on Day 1.
Receives: Radiation: Radiation therapy

What is being measured

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

  1. Feasibility, measured as the number of patients completing treatment.

    Number of patients completing treatment with at least one cycle of pembrolizumab and completion of RT (Arm A) or completion of RT (Arm B). Up to 6 replacements are allowed (total subjects 6-12)

    Measured: Up to 3 years

Secondary outcomes (9)

  1. Overall response rate (ORR) at non-irradiated sites

    The overall response rate (ORR) at non-irradiated sites will be measured by iRECIST and will exclude the irradiated tumor. ORR rate is defined as the number of patients with a best overall response (BOR/iBOR) of complete response (CR/iCR) or partial response (PR/iPR) divided by the total number of patients enrolled in the study.

    Measured: Up to 3 years.

  2. Local failure at the irradiated site

    Local failure rate at the irradiated site will be determined using cumulative incidence rates with death as a competing event at 12 months after initiation of treatment

    Measured: Up to 3 years

  3. Duration of response

    The duration of response is measured from the time measurement criteria are met for CR/PR or iCR/iPR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

    Measured: Up to 3 years

  4. Progression-free survival

    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.

    Measured: Up to 3 years.

  5. Overall survival

    The duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.

    Measured: Up to 3 years

  6. Number of grade 3-5 adverse events

    Severe toxicity will be measured by cumulative CTCAE v5.0 grade 3-5 events. Evaluation for toxicity will be made at Day 1 of each cycle, end of treatment, and in follow-up for up to 12 months following discontinuation of treatment.

    Measured: Up to 3 years.

  7. Patient reported health-related quality of life

    Mean summary score of the Functional Assessment of Cancer Therapy-General (FACT-G)

    Measured: Up to 3 years.

  8. Patient reported toxicity

    Mean summary score of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM).

    Measured: Up to 3 years.

  9. Patient reported treatment satisfaction

    Mean summary score of the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G).

    Measured: Up to 3 years.

Timeline

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

  1. First posted4 Aug 2022
  2. Study start3 Aug 2022
  3. Primary completion27 Jun 2025
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05488366
Sponsor's protocol ID
978
Other IDs
UCI 21-03
Status last verified
Oct 2026
First submitted
1 Aug 2022
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Harris JP, Park J, Ku E, Seyedin S, Stitzlein R, Goldin A, Chen WP, McLaren C, Chen AM, Chow W. A Pilot Study of Pembrolizumab Combined With Stereotactic Ablative Radiotherapy for Patients With Advanced or Metastatic Sarcoma. Cancer Control. 2024 Jan-Dec;31:10732748241237331. doi: 10.1177/10732748241237331.

    PubMed 38449377

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pembrolizumab and Radiation therapy in people with Sarcoma, Soft Tissue, run by University of California, Irvine 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 28 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Feasibility, measured as the number of patients completing treatment. (time frame: Up to 3 years). 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 NCT05488366, which also lists 1 linked publication.

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 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in