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Immune Checkpoint Inhibitor and MR-guided SBRT for Limited Progressive Metastatic Carcinoma.

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ClinicalTrials.gov Identifier: NCT04376502
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Viewray Inc.
Information provided by (Responsible Party):
Baptist Health South Florida

Brief Summary:
This is an open label single arm phase 2 clinical trial in patients with metastatic solid malignancy of any histology who have previously experienced limited progression in at least 1 and up to 5 lesions while on immune checkpoint inhibitors monotherapy.

Condition or disease Intervention/treatment Phase
Metastatic Carcinoma Radiation: Radiation Therapy Not Applicable

Detailed Description:

All potential subjects are required to undergo screening evaluation to determine eligibility within 28 days of study enrollment.

Eligible subjects will continue the same immune checkpoint inhibitors on which they experienced limited progression and will also receive radiation therapy. radiation therapy for all subjects will consist of treating one tumor of the treating physician's preference, and after a 1-week interval during which immune checkpoint inhibitor is continued alone, radiation therapy will be given to a second and separate tumor. No additional radiation therapy will be delivered. immune checkpoint inhibitors will be continued until disease progression or unacceptable toxicity. Diagnostic imaging studies will be performed to determine treatment response at baseline/screening, 8 weeks after initiation of radiation therapy to the first lesion and every 8 weeks thereafter.

Peripheral blood mononuclear cell composition will be evaluated at various time points within 14 days of starting radiation therapy, on Day 8 (1 week after starting radiation therapy to the first lesion), Day 23 (1 week after starting radiation therapy to the second lesion), and 8 weeks after treatment initiation.

A total of 52 subjects will be enrolled on this trial. The expected rate of accrual is 2 patients per month at a single institution over 26 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Radiation therapy for all subjects will consist of treating one tumor of the treating physician's preference (40 Gray (GY) in 5 fractions), and after a 1-week interval during which Immune checkpoint inhibitor is continued alone, radiation therapy will be given to a second and separate tumor (30 Gy in 5 fractions).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Immune Checkpoint Inhibitor and Novel in Situ Radiation "Booster Shot" Tumor Vaccination in Patients With Metastatic Carcinoma
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : November 17, 2023
Estimated Study Completion Date : November 17, 2024

Arm Intervention/treatment
radiation therapy (RT)
RT for all subjects will consist of treating one tumor of the treating physician's preference (40 Gy in 5 fractions), and after a 1-week interval during which Immune checkpoint inhibitor (ICI) is continued alone, RT will be given to a second and separate tumor (30 Gy in 5 fractions).
Radiation: Radiation Therapy
Radiation therapy for all subjects will consist of treating one tumor of the treating physician's preference (40 Gray (Gy) in 5 fractions), and after a 1-week interval during which ICI is continued alone, radiation therapy will be given to a second and separate tumor (30 Gy in 5 fractions).




Primary Outcome Measures :
  1. Change in overall response rate according to RECIST 1.1 criteria [ Time Frame: 6 month ]
    Change in overall response rate according to RECIST 1.1 criteria of non-irradiated lesions in metastatic cancer patients receiving immune checkpoint inhibitor and radiation therapy during a 6-month period.


Secondary Outcome Measures :
  1. Number of treatment related adverse events [ Time Frame: through study completion, an average of 1 year ]
    Treatment related adverse events will be tabulated and summarized by grade.

  2. Change in immune-related response criteria [ Time Frame: 6 month ]
    Change in Immune-related response criteria in non-irradiated lesion(s).

  3. Duration of response [ Time Frame: 6 month ]
    Duration of response from the time complete (CR) or partial response (PR) rate is first determined until the first date of documented progressive disease.

  4. Number of overall survival [ Time Frame: 6 month ]
    Number of overall survival from the start of radiation therapy of the first lesion to the date of death for any cause.

  5. Measure the number of progression free survival [ Time Frame: 6 month ]
    Measuring the number of progression free survival from the start of radiation therapy of the first lesion to the date of progressive disease or death for any causing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age at the time of study entry.
  2. Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
  3. Life expectancy of .12 weeks as estimated by the treating physician.
  4. Metastatic carcinoma confirmed by biopsy or imaging study if biopsy is not deemed feasible.
  5. Most recent anti-cancer therapy consists of a single ICI drug including but not limited to ipilimumab, nivolumab, pembrolizumab, atezolizumab.
  6. Radiographic evidence of progression while on a single ICI drug in 1 and up to 5 lesions.
  7. Eligible to continue ICI during and after radiation therapy.
  8. 3 radiographically distinct and measurable lesions (primary and/or metastatic lesions) by RECIST 1.1 criteria, with .3 lesions separated from each other by .5 cm
  9. Subjects must consent to all study procedures described in the protocol including radiographic evaluation and blood draws.
  10. Immunosuppressive doses of systemic medication including steroids must be discontinued at least 14 days prior to the start of radiation therapy.
  11. Adequate normal organ and marrow function
  12. Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: .60 years old and no menses for .1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy), have a negative serum pregnancy test within 14 days of study enrollment, and not be breastfeeding.

Exclusion Criteria:

  1. Any contraindication to having an MRI scan.
  2. Chemotherapy, biologic agent, investigational therapy, or radiation therapy given within 14 days of study enrollment.
  3. Symptomatic or uncontrolled brain metastasis requiring treatment.
  4. The need for palliative radiation therapy to a non-target lesion prior to radiation therapy to one of 2 target lesion on this study.
  5. Prior radiation therapy to any lesion that would receive radiation therapy on this protocol.
  6. Prior radiation therapy to a lesion located within 4 cm of previously irradiated structures: spinal cord that previously received >45 Gy; brachial plexus that previously received >45 Gy; small/large intestine or stomach that previously received >45 Gy; prior total lung V20 >30%.
  7. Prior radiation therapy that could lead to an unacceptably high risk of clinically significant normal tissue injury due to high cumulative normal tissue dose as determined by the investigator.
  8. History of any primary malignancy with the exception of

    1. Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study.
    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    3. Adequately treated carcinoma in situ without evidence of disease (i.e. cervical carcinoma in situ; superficial bladder cancer).
  9. Any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to worsen by treatment on this study are permitted to enroll on this study.
  10. Active or prior documented autoimmune disease within the past 2 years. Subjects with vitiligo, type I diabetes mellitus, Graves disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
  11. Subjects requiring systemic corticosteroid (>10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of study enrollment.
  12. Contraindication to IV contrast despite premedication for iodine allergy, which would limit the ability to assess radiographic response to study treatment.
  13. Prior allogeneic organ transplantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376502


Contacts
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Contact: Michael D Chuong, MD 786-596-2000 MichaelChu@baptisthealth.net

Locations
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United States, Florida
Miami Cancer Institute at Baptist Health South Florida Recruiting
Miami, Florida, United States, 33176
Contact: Michael Chuong, MD    786-596-2000    michalchu@baptisthealth.net   
Principal Investigator: Michael Chuong, MD         
Sponsors and Collaborators
Baptist Health South Florida
Viewray Inc.
Investigators
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Principal Investigator: Michael D Chuong, MD Miami Cancer Institute (MCI) at Baptist Health, Inc.
Additional Information:
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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT04376502    
Other Study ID Numbers: 2018-CHU-001
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baptist Health South Florida:
radiation
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms