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AzTrials

Solid TumorPhase 1NCT06416436

Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients

A Phase 1 study testing Atezolizumab and Stereotactic Ablative Radiotherapy (SBRT) in people with Solid Tumor, run by University of Kansas Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether cytoreduction of bulky metastatic disease using ultra high dose SBRT in combination with immunotherapy is tolerable and feasible In patients who have exhausted SoC treatment options. 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?
Atezolizumab and Stereotactic Ablative Radiotherapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Jul 2024to 15 Jul 2024
Phase
Phase 1
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

  • Ability of participant to understand this study, and participant willingness to sign a written informed consent
  • Males and females age ≥ 18 years
  • Measurable disease by RECIST 1.1 Participants must have at least two radiographically identifiable lesions measurable by RECIST v1.1 criteria and one of those lesions must be ≥65 cc. NOTE: 'cc' equals (width x length x height)/2 to provide rough approximation. For example, a 5.1 x 5.1 x 5.1 cm tumor would be 66.3 cc and appropriate for trial enrollment
  • Participants must have washout period of 5 elimination half-lives or 28 days (whichever is longer) from time of last systemic therapy to start of study treatment
  • Women of childbearing potential must have a negative serum pregnancy test at time of enrollment (at screening and up to 48 hours prior to start of radio- or immuno- therapy)
  • Participants with biopsy and radiographically confirmed metastatic cancer (i.e., Lung, head and neck, ovarian, colorectal, sarcoma)
Show all 30Show fewer
  • At least 1st line (1L) systemic therapy or immunotherapy must have failed for participants and standard of care therapy options must also be exhausted. Standard of care options that have been discontinued for reasons other than disease progression are eligible. NOTE: Participants who are off systemic therapy who are being monitored with surveillance imaging, who then develop disease progression and are without standard of care therapy options are eligible for enrollment.
  • At least one lesion (and up to a maximum of four lesions) must be ≥65 cc (calculated using tumor length x width x height to closest approximation)
  • Prior RT is permitted if the lesion to be treated and surrounding region (no appreciable dosimetric overlap, assessed on case-by-case basis as needed) with ultra-high dose SBRT was not previously treated
  • Participants with CNS metastatic disease will be allowed on protocol if all lesions are managed prior to starting extra-CNS ablative therapy
  • Availability of a representative (FFPE) tumor specimen from metastatic diagnosis of cancer done prior to any study intervention for exploratory study-related biomarker research
  • Adequate organ function, defined as the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
  • Leukocytes ≥ 3K/µL
  • Lymphocyte count ≥ 0.5 x 10^9/L (500/µL)
  • Absolute Neutrophil Count ≥1.5K/µL without granulocyte colony-stimulating factor support. NOTE: Participants with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the participant
  • Platelets ≥100K/μL) without transfusion
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) [calculated using the Cockcroft-Gault formula]
  • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN. Participants with known Gilbert disease: serum bilirubin ≤ 3 x ULN
  • Serum albumin ≥ 35 g/L (3.5 g/dL)
  • Aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  • For participants not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN
  • For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/µL, and have an undetectable viral load. *** NOTE: A participant may be eligible if test is positive and will be left to the investigator to determine appropriateness for trial enrollment if medically stable and without signs of active, uncontrolled disease. Prior to formal enrollment, please contact protocol study PI to review.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test must be performed for participants who have a positive HCV antibody test.*** NOTE: A participant may be eligible if test is positive and will be left to the investigator to determine appropriateness for trial enrollment if medically stable and without signs of active, uncontrolled disease. Prior to formal enrollment, please contact protocol study PI to review.
  • Negative hepatitis B surface antigen (HbsAg) test at screening. Negative total hepatitis B core antibody (HbcAb) test at screening, or positive total HbcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for participants who have a negative HbsAg test and a positive total HbcAb test. *** NOTE: A participant may be eligible if test is positive and will be left to the investigator to determine appropriateness for trial enrollment if medically stable and without signs of active, uncontrolled disease. Prior to formal enrollment, please contact protocol study PI to review.
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section and below for the duration of study participation and for 180 DAYS/6 MONTHS following completion of therapy. Men must refrain from donating sperm during this same period.
  • A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
  • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.

Who cannot join

  • Simultaneously enrolled in any therapeutic clinical trial
  • Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Is pregnant or breastfeeding
  • Female of childbearing potential planning to become pregnant while receiving study treatment or for less than 180 DAYS/6 MONTHS after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result at time of enrollment (at screening and up to 48 hours prior to start of radio- or immuno- therapy).
  • Male of childbearing potential planning to father a child or donate sperm while receiving study treatment or for less than 180 DAYS / 6 MONTHS after the last dose of study treatment
Show all 52Show fewer
  • Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
  • COVID-19: Participants with active COVID-19 symptoms and/or hospitalized for severe or critical COVID-19 symptoms
  • Participants with uncontrolled concurrent illness or infection (i.e., active pneumonia or infection)
  • Participants with only bone metastatic disease
  • Immunosuppressive disorders (i.e., solid organ transplant recipient, allogeneic stem cell transplant) (please refer Appendix D for full list)
  • Participants who are enrolled in hospice or felt to have less than 6 months life expectation
  • Uncontrolled or untreated CNS metastases
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Asymptomatic participants with treated CNS lesions are eligible, provided that all of the following criteria are met:
  • Measurable disease, per RECIST v1.1, must be present outside the CNS
  • The participant has no history of intracranial hemorrhage or spinal cord hemorrhage
  • The participant has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
  • The participant has no ongoing requirement for corticosteroids as therapy for CNS disease
  • If the participant is receiving anti-convulsant therapy, the dose is considered stable
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). • Participants with indwelling catheters (e.g., PleurX) are allowed.
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN
  • Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry.
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
  • Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
  • Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
  • Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • See also Appendix D for list of autoimmune diseases and immune deficiencies
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Active tuberculosis
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact participant safety
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • Current treatment with anti-viral therapy for HBV
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with checkpoint blockade therapy
  • History of prior immunotherapy induced pneumonitis and/or peritonitis that is Grade ≥3 is not permitted (instance of Grade 1 or 2 that have fully recovered and tolerated subsequent immunotherapy is permitted)
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
  • Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study
  • Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • Known allergy or hypersensitivity to any component of the atezolizumab formulation
  • Has a known allergic reaction to any excipient contained in the study drug formulation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: Immunotherapy in Combination With Ablative Radiosurgery to Ultra-high DoSes (ICARUS): A Phase I Dose-escalation Radiosurgery Study in Metastatic Cancers

The purpose of this study is to determine whether cytoreduction of bulky metastatic disease using ultra high dose SBRT in combination with immunotherapy is tolerable and feasible In patients who have exhausted SoC treatment options.

Read the detailed description

Patients that provide informed consent will undergo a 30-day screening period to determine eligibility for the trial. If eligible, patients will begin treatment on SBRT (delivered to metastases over 3-5 fractions within 1-2 weeks) with concurrent and adjuvant atezolizumab (1680 mg on Day 1 of each 28-day cycle) immunotherapy regimen for up to one year.

Conditions
Solid Tumor
Being tested
Atezolizumab, Stereotactic Ablative Radiotherapy (SBRT)
Keywords
Stereotactic Ablative Radiotherapy, SBRT, Atezolizumab, Tecentriq, Metastatic, Phase I
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • AtezolizumabDrug

    Atezolizumab will be administered at a fixed dose of 1680 mg IV route every 4 weeks (1680 mg on Day 1 of each 28-day cycle), which is an approved dosage for atezolizumab, as outlined in the prescribing information.

  • Stereotactic Ablative Radiotherapy (SBRT)Radiation

    Ultra-High Doses of Ablative Radiosurgery

    SBRT is delivered to metastases over 3-5 fractions within 1-2 weeks

Study groups in NCT06416436
Study groupRoleWhat they receive
SBRT with concurrent and adjuvant atezolizumab immunotherapyExperimentalNot described
Receives: Drug: Atezolizumab; Radiation: Stereotactic Ablative Radiotherapy (SBRT)

What is being measured

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

  1. Maximum tolerated dose of ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) for 3 different body sites

    Maximum tolerated dose of ultra-high dose SBRT for 3 different body sites (i.e., peripheral lung, mediastinum-central lung, and abdomen-pelvis)

    Measured: 1 Month

Secondary outcomes (4)

  1. Evaluate the number of participants receiving ultra-high dose ablative radiosurgery with immunotherapy who develop treatment-related adverse events as assessed by CTCAE v4.0

    To assess the safety of ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options

    Measured: Enrollment to 1 month after end of SBRT treatment (approximately 2 months)

  2. Overall tumor response rate to ultra-high dose SBRT for 3 different body sites

    To assess the overall tumor response rate of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab

    Measured: Pre-treatment to 3 and 6 months after SBRT (approximately 7 months)

  3. Progression-Free Survival of participants receiving ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) with concurrent and adjuvant atezolizumab

    To assess the progression-free survival of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options.

    Measured: Up to 2 years

  4. Overall Survival of participants receiving ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) with concurrent and adjuvant atezolizumab

    To assess the overall survival of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options

    Measured: Up to 2 years

Timeline

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

  1. First posted16 May 2024
  2. Study start15 Jul 2024
  3. Primary completion15 Jul 2024
  4. Study completion15 Jul 2024

Why it stopped: Impasse during contract negotitations

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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Traditional 3+3 model
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06416436
Sponsor's protocol ID
IIT-2022-ICARUS
Status last verified
Jun 2025
First submitted
3 May 2024
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.

    PubMed 21376230

  • Ganesh K, Massague J. Targeting metastatic cancer. Nat Med. 2021 Jan;27(1):34-44. doi: 10.1038/s41591-020-01195-4. Epub 2021 Jan 13.

    PubMed 33442008

  • Corkum MT, Rodrigues GB. Patient selection for thoracic radiotherapy in extensive-stage small-cell lung cancer. Lung Cancer Manag. 2017 Nov;6(2):47-53. doi: 10.2217/lmt-2017-0006. Epub 2017 Nov 17.

    PubMed 30643570

  • Lutz ST, Jones J, Chow E. Role of radiation therapy in palliative care of the patient with cancer. J Clin Oncol. 2014 Sep 10;32(26):2913-9. doi: 10.1200/JCO.2014.55.1143. Epub 2014 Aug 11.

    PubMed 25113773

  • Rodrigues G, Videtic GM, Sur R, Bezjak A, Bradley J, Hahn CA, Langer C, Miller KL, Moeller BJ, Rosenzweig K, Movsas B. Palliative thoracic radiotherapy in lung cancer: An American Society for Radiation Oncology evidence-based clinical practice guideline. Pract Radiat Oncol. 2011 Apr-Jun;1(2):60-71. doi: 10.1016/j.prro.2011.01.005. Epub 2011 Apr 8.

    PubMed 25740118

  • 8 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomised comparison with a multifraction schedule over 12 months of patient follow-up. Bone Pain Trial Working Party. Radiother Oncol. 1999 Aug;52(2):111-21.

    PubMed 10577696

  • Waldman AD, Fritz JM, Lenardo MJ. A guide to cancer immunotherapy: from T cell basic science to clinical practice. Nat Rev Immunol. 2020 Nov;20(11):651-668. doi: 10.1038/s41577-020-0306-5. Epub 2020 May 20.

    PubMed 32433532

  • Hendry S, Salgado R, Gevaert T, Russell PA, John T, Thapa B, Christie M, van de Vijver K, Estrada MV, Gonzalez-Ericsson PI, Sanders M, Solomon B, Solinas C, Van den Eynden GGGM, Allory Y, Preusser M, Hainfellner J, Pruneri G, Vingiani A, Demaria S, Symmans F, Nuciforo P, Comerma L, Thompson EA, Lakhani S, Kim SR, Schnitt S, Colpaert C, Sotiriou C, Scherer SJ, Ignatiadis M, Badve S, Pierce RH, Viale G, Sirtaine N, Penault-Llorca F, Sugie T, Fineberg S, Paik S, Srinivasan A, Richardson A, Wang Y, Chmielik E, Brock J, Johnson DB, Balko J, Wienert S, Bossuyt V, Michiels S, Ternes N, Burchardi N, Luen SJ, Savas P, Klauschen F, Watson PH, Nelson BH, Criscitiello C, O'Toole S, Larsimont D, de Wind R, Curigliano G, Andre F, Lacroix-Triki M, van de Vijver M, Rojo F, Floris G, Bedri S, Sparano J, Rimm D, Nielsen T, Kos Z, Hewitt S, Singh B, Farshid G, Loibl S, Allison KH, Tung N, Adams S, Willard-Gallo K, Horlings HM, Gandhi L, Moreira A, Hirsch F, Dieci MV, Urbanowicz M, Brcic I, Korski K, Gaire F, Koeppen H, Lo A, Giltnane J, Rebelatto MC, Steele KE, Zha J, Emancipator K, Juco JW, Denkert C, Reis-Filho J, Loi S, Fox SB. Assessing Tumor-infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method From the International Immunooncology Biomarkers Working Group: Part 1: Assessing the Host Immune Response, TILs in Invasive Breast Carcinoma and Ductal Carcinoma In Situ, Metastatic Tumor Deposits and Areas for Further Research. Adv Anat Pathol. 2017 Sep;24(5):235-251. doi: 10.1097/PAP.0000000000000162.

    PubMed 28777142

  • Miyashita M, Sasano H, Tamaki K, Hirakawa H, Takahashi Y, Nakagawa S, Watanabe G, Tada H, Suzuki A, Ohuchi N, Ishida T. Prognostic significance of tumor-infiltrating CD8+ and FOXP3+ lymphocytes in residual tumors and alterations in these parameters after neoadjuvant chemotherapy in triple-negative breast cancer: a retrospective multicenter study. Breast Cancer Res. 2015 Sep 4;17(1):124. doi: 10.1186/s13058-015-0632-x.

    PubMed 26341640

  • Yang C, Jin J, Yang Y, Sun H, Wu L, Shen M, Hong X, Li W, Lu L, Cao D, Wang X, Sun J, Ye Y, Su B, Deng L. Androgen receptor-mediated CD8+ T cell stemness programs drive sex differences in antitumor immunity. Immunity. 2022 Jul 12;55(7):1268-1283.e9. doi: 10.1016/j.immuni.2022.05.012. Epub 2022 Jun 13.

    PubMed 35700739

  • Ying L, Yan F, Meng Q, Yu L, Yuan X, Gantier MP, Williams BRG, Chan DW, Shi L, Tu Y, Ni P, Wang X, Chen W, Zang X, Xu D, Hu Y. PD-L1 expression is a prognostic factor in subgroups of gastric cancer patients stratified according to their levels of CD8 and FOXP3 immune markers. Oncoimmunology. 2018 Feb 20;7(6):e1433520. doi: 10.1080/2162402X.2018.1433520. eCollection 2018.

    PubMed 29872566

  • Ribas A, Wolchok JD. Cancer immunotherapy using checkpoint blockade. Science. 2018 Mar 23;359(6382):1350-1355. doi: 10.1126/science.aar4060. Epub 2018 Mar 22.

    PubMed 29567705

  • Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. Immunol Rev. 2010 Jul;236:219-42. doi: 10.1111/j.1600-065X.2010.00923.x.

    PubMed 20636820

  • Baumeister SH, Freeman GJ, Dranoff G, Sharpe AH. Coinhibitory Pathways in Immunotherapy for Cancer. Annu Rev Immunol. 2016 May 20;34:539-73. doi: 10.1146/annurev-immunol-032414-112049. Epub 2016 Feb 25.

    PubMed 26927206

  • Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239.

    PubMed 22437870

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab and Stereotactic Ablative Radiotherapy (SBRT) in people with Solid Tumor, run by University of Kansas Medical Center 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 30 inclusion and 52 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: withdrawn, as of the sponsor's last update on 29 Jun 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.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Maximum tolerated dose of ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) for 3 different body sites (time frame: 1 Month). 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 NCT06416436, which also lists 92 linked publications.

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 29 Jun 2025.

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