Trial Outcomes & Findings for Immune Checkpoint Inhibitor and MR-guided SBRT for Limited Progressive Metastatic Carcinoma. (NCT NCT04376502)

Last Updated: 2025-01-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2025-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	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 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).
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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 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).
Overall Study Deemed ineligible after being enrolled	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy (RT) n=12 Participants 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 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	64.92 years STANDARD_DEVIATION 9.74 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Six participants did not receive 6-month imaging and response evaluation. Five were taken off study due to disease progression (two), new AE that made them ineligible to continue (one), other ineligibility (one), or expiration (one). One participant had missed imaging.

Outcome measures

Outcome measures
Measure	Radiation Therapy (RT) n=6 Participants 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 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).
Change in Overall Response Rate (ORR) According to RECIST 1.1 Criteria	1 Participants

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

Population: One participant was deemed ineligible after being considered enrolled and was thus withdrawn.

Treatment related adverse events are defined as those possibly, probably, or definitely related to the study treatment. These events will be tabulated and reported by grade of severity.

Outcome measures

Outcome measures
Measure	Radiation Therapy (RT) n=11 Participants 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 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).
Number of Treatment Related Adverse Events Mild (Grade 1)	19 events
Number of Treatment Related Adverse Events Moderate (Grade 2)	7 events
Number of Treatment Related Adverse Events Severe (Grade 3)	6 events
Number of Treatment Related Adverse Events Life-threatening (Grade 4)	0 events
Number of Treatment Related Adverse Events Death (Grade 5)	0 events

SECONDARY outcome

Timeframe: 6 month

irORR is the percent of patients with best overall response of irCR or irPR from the start of the study until 6 months later. Only index and measurable new lesions are taken into account in irRC and response is defined over at least 4 weeks. irCR is defined as the disappearance of all lesions in two observations at least 4 weeks apart. irPR is defined as at least 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.

Outcome measures

Outcome measures
Measure	Radiation Therapy (RT) n=6 Participants 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 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).
Change in Immune-related ORR (irORR) According to Immune-related Response Criteria (irRC)	1 Participants

SECONDARY outcome

Timeframe: 6 month

Population: Only two participants ever had PR. None had CR. Out of the two participants with PR, one did not have progression during the time points when response was assessed, thus was not included in this calculation.

Duration of response is defined as the time from when CR or PR is first determined until the first date of documented progressive disease (PD) or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Radiation Therapy (RT) n=1 Participants 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 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).
Duration of Response	55 days

SECONDARY outcome

Timeframe: 2 years

Population: One participant was deemed ineligible after being considered enrolled and was thus withdrawn.

OS is defined as the percent of participants who are alive at the end of the study. Death due to any cause will be considered.

Outcome measures

Outcome measures
Measure	Radiation Therapy (RT) n=11 Participants 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 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).
Overall Survival (OS)	5 Participants

SECONDARY outcome

Timeframe: 6 month

Population: One participant was deemed ineligible after being considered enrolled and was thus withdrawn.

PFS is defined as the amount of time from first treatment to disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Radiation Therapy (RT) n=11 Participants 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 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).
Progression-free Survival (PFS)	2.5 months Interval 1.0 to Upper bound was not reached for time to event analysis due to lack of enough events observed in the study population by the end of follow-up. Specifically, due to small sample size to start, compounded by censoring of data, many patients did not have the event. Therefore, the upper bound of the 95% confidence interval could not be calculated.

Adverse Events

Radiation Therapy (RT)

Serious events: 3 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Radiation Therapy (RT) n=11 participants at risk 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 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).
Gastrointestinal disorders Abdominal Pain	9.1% 1/11 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Number of events 2 • 2 years
Vascular disorders Hypotension	9.1% 1/11 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	9.1% 1/11 • Number of events 1 • 2 years
Vascular disorders Thromboembolic event	9.1% 1/11 • Number of events 1 • 2 years

Other adverse events

Other adverse events
Measure	Radiation Therapy (RT) n=11 participants at risk 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 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).
General disorders Fatigue	45.5% 5/11 • Number of events 10 • 2 years
Gastrointestinal disorders Nausea	36.4% 4/11 • Number of events 5 • 2 years
Infections and infestations Infections and infestations - Other, COVID-19	36.4% 4/11 • Number of events 4 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	27.3% 3/11 • Number of events 5 • 2 years
Gastrointestinal disorders Abdominal Pain	27.3% 3/11 • Number of events 3 • 2 years
Metabolism and nutrition disorders Anorexia	27.3% 3/11 • Number of events 3 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • Number of events 4 • 2 years
General disorders Edema limbs	18.2% 2/11 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Lung infection	18.2% 2/11 • Number of events 2 • 2 years
Nervous system disorders Peripheral neuropathy	18.2% 2/11 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumonia	18.2% 2/11 • Number of events 2 • 2 years
Investigations Weight loss	18.2% 2/11 • Number of events 2 • 2 years
Investigations Aspartate aminotransferase increase	9.1% 1/11 • Number of events 4 • 2 years
Investigations Alanine aminotransferase increase	9.1% 1/11 • Number of events 3 • 2 years
Injury, poisoning and procedural complications Dermatitis radiation	9.1% 1/11 • Number of events 2 • 2 years
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 2 • 2 years
Gastrointestinal disorders Ascites	9.1% 1/11 • Number of events 1 • 2 years
Infections and infestations Bacteremia	9.1% 1/11 • Number of events 1 • 2 years
Cardiac disorders Cardiac arrest	9.1% 1/11 • Number of events 1 • 2 years
Investigations Creatinine increased	9.1% 1/11 • Number of events 1 • 2 years
Psychiatric disorders Depression	9.1% 1/11 • Number of events 1 • 2 years
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • 2 years
Nervous system disorders Dizziness	9.1% 1/11 • Number of events 1 • 2 years
Skin and subcutaneous tissue disorders Erythema	9.1% 1/11 • Number of events 1 • 2 years
General disorders Generalized edema	9.1% 1/11 • Number of events 1 • 2 years
General disorders Generalized muscle weakness	9.1% 1/11 • Number of events 1 • 2 years
Hepatobiliary disorders Hepatobiliary disorders - Other, Biliary ductal dilation	9.1% 1/11 • Number of events 1 • 2 years
Endocrine disorders Hypothyroidism	9.1% 1/11 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Hypoxia	9.1% 1/11 • Number of events 1 • 2 years
Infections and infestations Infections and infestations - Other, Metapneumovirus	9.1% 1/11 • Number of events 1 • 2 years
Investigations Investigations - Other, Hyperbilirubinemia	9.1% 1/11 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • Number of events 1 • 2 years
General disorders Pain	9.1% 1/11 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	9.1% 1/11 • Number of events 1 • 2 years
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 1/11 • Number of events 1 • 2 years
Vascular disorders Thromboembolic event	9.1% 1/11 • Number of events 1 • 2 years
Nervous system disorders Tremor	9.1% 1/11 • Number of events 1 • 2 years
Eye disorders Watering eyes	9.1% 1/11 • Number of events 1 • 2 years

Additional Information

Director, Research Concept & Protocol Development

Miami Cancer Institute at Baptist Health, Inc.

Phone: (786) 527-9546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place