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CancerPhase 1C4-MOSARTNCT03431948

Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer

A Phase 1 study testing Nivolumab, Cabiralizumab and Urelumab in people with Cancer, run by University of Chicago 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

Study to determine the best dose of stereotactic body radiation therapy (SBRT) to be administered in combination with immunotherapy drugs including urelumab, cabiralizumab and nivolumab . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Nivolumab, Cabiralizumab and Urelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
15 Mar 2018to 11 Apr 2022
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

  • Willingness and ability to provide written informed consent
  • Willingness and ability to comply with required study visits and procedures
  • For Biopsy Patients: Willingness to undergo repeat biopsy of tumor before and after treatment
  • Men or women ≥ 18 years of age.
  • Histologically confirmed advanced solid tumor for which curative treatment is not available.
  • Have undergone appropriate standard of care treatment options (in the opinion of the treating investigator). Participants with NSCLC must have undergone EGFR and ALK testing and have received appropriate initial therapy.
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  • Measurable disease, including at least one tumor lesion that meets criteria for multi-organ site ablative radiation therapy (MOSART) SBRT radiation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Adequate organ function, as defined by the following:
  • Absolute neutrophil count (ANC) ≥ 1,500/µL
  • Platelets ≥ 100 x 10^3/µL
  • Hemoglobin ≥ 8 g/dL without transfusion or EPO dependency
  • Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCL) > 50 mL/min (creatinine clearance should be calculated per institutional standard). GFR can also be used in place of creatinine of CrCl.
  • Serum total bilirubin ≤1.5 x institutional ULN (except subjects with Gilbert's Syndrome, who must have normal direct bilirubin).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x institutional ULN OR ≤ 5x ULN for subjects with liver metastases.
  • Albumin > 3.2 mg/dL.
  • Prior immuno-oncology (IO) therapy
  • Have a physician determined life expectancy of at least 6 months.
  • Negative pregnancy test for women of childbearing potential (WOCBP) within 72 hours of starting therapy
  • Must not be breastfeeding
  • Woman of childbearing potential: Must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) and up to 5 months post last dose of study drug(s).
  • Men: Must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) and up to 7 months post last dose of study drug(s). Must be willing to refrain from sperm donation during this time.

Who cannot join

  • Must not be currently receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Must not have had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or have not recovered (i.e. < grade 1 at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Must not have had prior chemotherapy, targeted small molecule therapy, radiation or other anti-cancer therapy (with exceptions for disease-specific hormone treatments considered standard of care) within 2 weeks prior to study Day 1 or have not recovered (i.e. < grade 1 or at baseline) from adverse events due to a previously administered agent. Exception for ≤ grade 2 neuropathy. If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Must not have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
  • Must not have had prior radiation therapy (defined as >10% of prior prescription dose) to the area planning to be treated with SBRT.
  • Must not have a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a dose of >10 mg prednisone daily or equivalent at time of first dose of trial treatment.
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  • Must not have a known history of active TB (Bacillus Tuberculosis)
  • Must not have hypersensitivity to nivolumab, urelumab, cabiralizumab or any of their excipients.
  • Must not have a known additional malignancy that could confuse analysis of on-study treatment. Inclusion of all study participants with more than one malignancy must be discussed and approved by the PI.
  • Must not have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroids replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Must not have a known history of non-infectious pneumonitis that required steroids for treatment.
  • Must not have evidence of interstitial lung disease.
  • Must not have an active infection requiring systemic therapy.
  • Must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • If known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) then patient is not eligible for cohorts including SBRT to liver lesions.
  • Participants must not have had prior organ allograft or allogeneic bone marrow transplantation.
  • Participants must not have had uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
  • Myocardial infarction or stroke/transient ischemic attack within the past 6 months
  • Uncontrolled angina within the past 3 months
  • Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  • History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, significant pericardial effusion, or myocarditis)
  • Cardiovascular disease-related requirement for daily supplemental oxygen therapy
  • Has received a live vaccine within 30 days of planned start of study therapy.
  • Participants may not concomitantly use statins while on study. However, a patient using statins for over 3 months prior to study drug administration and in stable status without CK rise may be permitted to enroll.
  • Participants may not have current or history of clinically significant muscle disorders (eg, myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
  • Must not have a history of allergy to nivolumab, urelumab or cabiralizumab.
  • Must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity) to prior anti-cancer immune-modulating therapies (eg, checkpoint inhibitors and T-cell co-stimulatory antibodies).
  • Must not be prisoners or be involuntarily incarcerated.
  • Must not be compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Platform Phase 1 Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Immuno-oncology Agents for the Treatment of Multiple Metastases in Advanced Solid Tumors

Study to determine the best dose of stereotactic body radiation therapy (SBRT) to be administered in combination with immunotherapy drugs including urelumab, cabiralizumab and nivolumab .

Conditions
Cancer
Being tested
Nivolumab, Cabiralizumab, Urelumab, Stereotactic Body Radiation Therapy
Medical subject headings
Neoplasms

What participants receive

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

  • NivolumabDrug

    Also called OPDIVO, BMS-936558

    Nivolumab 240 mg given by intravenous infusion every 2 weeks

  • CabiralizumabDrug

    Also called BMS-986227, FPA008

    Cabiralizumab 4 mg/kg given by intravenous infusion every 2 weeks

  • UrelumabDrug

    Also called BMS-663513

    Urelumab 8 mg given by intravenous infusion every 4 weeks

  • Stereotactic Body Radiation TherapyRadiation

    Radiation to metastatic lesion(s) given at assigned dose levels based on lesion location and dose level being tested at time of enrollment. Doses range from 30 - 50 Gy.

Study groups in NCT03431948
Study groupRoleWhat they receive
SBRT with Nivolumab and UrelumabExperimentalPatients will receive stereotactic body radiation therapy (SBRT) in combination with nivolumab and urelumab.
Receives: Drug: Nivolumab; Drug: Urelumab; Radiation: Stereotactic Body Radiation Therapy
SBRT with Nivolumab and CabiralizumabExperimentalPatients will receive stereotactic body radiation therapy (SBRT) in combination with nivolumab and cabiralizumab .
Receives: Drug: Nivolumab; Drug: Cabiralizumab; Radiation: Stereotactic Body Radiation Therapy

What is being measured

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

  1. Recommended dose of SBRT given in combination with immunotherapy

    Dose of stereotactic body radiation therapy (SBRT) that can safety be given with immunotherapy.

    Measured: 3 months

Secondary outcomes (6)

  1. Rates of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher side effects

    Rate of side effects seen in study participants.

    Measured: 3 months

  2. Rates of long term side effects

    Rate of long term (occurring 6 month or more after treatment) side effects seen in study participants.

    Measured: 6 - 24 months

  3. Response rate

    Rates of response (tumor shrinkage).

    Measured: 6 months

  4. Progression free survival rate

    Number of participants that do not have disease worsening.

    Measured: 6 months

  5. Overall survival rate

    Number of participants still alive.

    Measured: 6 - 24 months

  6. Local disease control of SBRT treated lesions

    Rate of disease control (tumor shrinkage) of radiation treated lesions.

    Measured: 6 months

Timeline

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

  1. First posted13 Feb 2018
  2. Study start15 Mar 2018
  3. Primary completion29 Feb 2020
  4. Study completion11 Apr 2022

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
Non-randomised
Intervention model
Parallel groups
Model description
Patients will be enrolled in parallel based on physician preference and slot availability.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03431948
Sponsor's protocol ID
IRB17-1317
Other IDs
CA025-002
Acronym
C4-MOSART
Status last verified
Feb 2023
First submitted
7 Feb 2018
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nivolumab, Cabiralizumab and Urelumab in people with Cancer, run by University of Chicago 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 22 inclusion and 31 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 16 Feb 2023. 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 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?

Recommended dose of SBRT given in combination with immunotherapy (time frame: 3 months). 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 NCT03431948.

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 16 Feb 2023.

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