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

NCT04376502 | Terminated Results DMC

• 1 other identifier: 2018-CHU-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Carcinoma

Keywords

radiation

Outcome Measures

Primary Outcomes (1)

• Change in Overall Response Rate (ORR) According to RECIST 1.1 Criteria

  ORR is defined as the percent of participants who have a partial response (PR) or complete response (CR) to therapy of non-irradiated lesions according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria assessed on CT imaging. CR is defined as the disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of the longest diameters of target lesions AND for non-target lesions, no progression of existing lesions or appearance of new lesions.

  6 months

Secondary Outcomes (5)

• Number of Treatment Related Adverse Events

  through study completion, an average of 1 year

• Change in Immune-related ORR (irORR) According to Immune-related Response Criteria (irRC)

  6 month

• Duration of Response

  6 month

• Overall Survival (OS)

  2 years

• Progression-free Survival (PFS)

  6 month

Study Arms (1)

radiation therapy (RT)

OTHER

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

Interventions

Radiation Therapy RADIATION

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).

radiation therapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Viewray Inc.: collaborator

Study Sites (1)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Related Links

• Miami Cancer Institute website

MeSH Terms

Conditions

Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

The study was terminated early because of poor enrollment. Because the study did not accrue the intended sample of participants, there was not enough power to conduct statistical analysis or calculate accurate estimates.

Results Point of Contact

• Title: Director, Research Concept & Protocol Development
• Organization: Miami Cancer Institute at Baptist Health, Inc.

MCIResearchConceptAndProtocolDev@baptisthealth.net

(786) 527-9546

Study Officials

• Michael D Chuong, MD

  Miami Cancer Institute (MCI) at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 6, 2020
• Study Start: April 8, 2020
• Primary Completion: June 16, 2023
• Study Completion: October 4, 2023
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Locations

US (1)