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

  • STATUS
    Recruiting
  • End date
    Nov 17, 2024
  • participants needed
    52
  • sponsor
    Baptist Health South Florida
Updated on 11 April 2021

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.

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.

Details
Condition Metastatic Carcinoma
Treatment radiation therapy
Clinical Study IdentifierNCT04376502
SponsorBaptist Health South Florida
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Metastatic Carcinoma?
Do you have any of these conditions: Do you have Metastatic Carcinoma??
Do you have any of these conditions: Do you have Metastatic Carcinoma??
Do you have any of these conditions: Do you have Metastatic Carcinoma??
18 years of age at the time of study entry
Eastern Cooperative Oncology Group performance status of 0, 1, or 2
Life expectancy of .12 weeks as estimated by the treating physician
Metastatic carcinoma confirmed by biopsy or imaging study if biopsy is not deemed feasible
Most recent anti-cancer therapy consists of a single ICI drug including but not limited to ipilimumab, nivolumab, pembrolizumab, atezolizumab
Radiographic evidence of progression while on a single ICI drug in 1 and up to 5 lesions
Eligible to continue ICI during and after radiation therapy
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
Subjects must consent to all study procedures described in the protocol including radiographic evaluation and blood draws
Immunosuppressive doses of systemic medication including steroids must be discontinued at least 14 days prior to the start of radiation therapy
Adequate normal organ and marrow function
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

Any contraindication to having an MRI scan
Chemotherapy, biologic agent, investigational therapy, or radiation therapy given within 14 days of study enrollment
Symptomatic or uncontrolled brain metastasis requiring treatment
The need for palliative radiation therapy to a non-target lesion prior to radiation therapy to one of 2 target lesion on this study
Prior radiation therapy to any lesion that would receive radiation therapy on this protocol
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%
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
History of any primary malignancy with the exception of
Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease (i.e. cervical carcinoma in situ; superficial bladder cancer)
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
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
Subjects requiring systemic corticosteroid (>10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of study enrollment
Contraindication to IV contrast despite premedication for iodine allergy, which would limit the ability to assess radiographic response to study treatment
Prior allogeneic organ transplantation
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