Solid Tumor
Conditions
Brief summary
The purpose of this study is to find out if having radiation therapy and continuing immunotherapy can improve the benefit of immunotherapy. There have been reports of patients who were treated with radiation therapy that not only caused the treated tumors to shrink or stop growing, but also resulted in tumors that had not been treated in other parts of the body to shrink or stop growing. This effect is thought to be brought about by cells in the body's immune system that become active as a result of the effects of radiation therapy. If radiation therapy can stimulate the immune system, it may be possible for immunotherapy to be helpful again in treating a cancer that the immunotherapy drug helped treat before. This study will also check if receiving immunotherapy at the end of radiation therapy has any effect on the side effects of radiation therapy or immunotherapy.
Detailed description
Stereotactic radiotherapy (SRT) will be delivered in up to 10 treatment fractions over 1 to 2 weeks. Patients will continue to receive the same FDA-approved programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor that they had been receiving at the time of disease progression through 52 weeks following completion of SRT. Correlative blood samples will be collected at baseline, prior to the second SRT fraction, after the last SRT fraction (on the same day), and at 8, 24, and 52 weeks after the last SRT fraction. These samples will be used to determine the mechanistic immunologic effects of therapy.
Interventions
RADIATIONStereotactic radiotherapy
Treatment will be planned to deliver a total of 18 to 60 Gy to the planning target volume (PTV) in 3 to 5 fractions over 1 to 2 weeks.
OTHERBiological: humanized anti-PD-1 monoclonal antibody
Standard of Care - patient will continue to be given the same PD-1 inhibitor they were receiving prior to study registration
OTHERBiological: humanized anti-PD-L1 monoclonal antibody
Standard of Care - patient will continue to be given the same PD-L1 inhibitor they were receiving prior to study registration
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Steriotactic Radiotherapy followed by a commercially available PD-1 or PD-L1 inhibitor drug
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically-proven diagnosis of a solid tumor malignancy * One of the following criteria must be met: * Clinical or radiographic evidence of disease control (defined as best response of stable disease (SD) or partial response (PR) or combination of both for ≥ 16 weeks) without evidence of complete response (CR) or progression OR * Clinical or radiographic evidence of disease progression during treatment with PD-1 or PD-L1 inhibiting therapy, following previous tumor response (CR, PR, or SD for ≥ 16 weeks) to PD-1 or PD-L1 inhibiting therapy, and, for patients who discontinued PD-1 or PD-L1 inhibiting therapy during response to therapy, disease progression must have occurred following at least 8 weeks of re-treatment with PD-1 or PD-L1 inhibiting therapy Note: Both the treating medical oncologist and radiation oncologist must be in agreement with determination of disease progression. * Administration of a PD-1 or PD-L1 inhibitor within 60 days prior to study registration * Determination by the treating radiation oncologist that the patient is a candidate for SRT (ie, radiation therapy with a stereotactic setup) Note: All brain metastases will receive stereotactic radiotherapy (SRT). * The total number of tumors requiring SRT must be ≤ 5 Note: Regardless of the number of brain metastases that will be treated with SRT, the brain metastases will be considered to be one tumor. * Measurable disease by RECIST v1.1 that will not undergo SRT and that is amenable to monitoring Note: all brain metastases will receive SRT. Therefore, a patient with brain metastases that will be treated with SRT must also have extracranial disease that will not undergo SRT and that is amenable to monitoring * Determination by the treating medical oncologist that the patient is a candidate to continue the PD-1 or PD-L1 inhibiting therapy that had previously provided disease control * Age ≥ 18 years * Karnofsky Performance Status score of ≥ 60 % * A woman of childbearing potential (WCBP), defined as a woman who is \< 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 14 days prior to initiating study treatment * Ability to understand and willingness to sign the consent form
Exclusion criteria
* Other anti-cancer therapy administered between the time of tumor response to PD-1 or PD-L1 therapy and time of study enrollment Note: Patients treated with a combination of PD-1 or PD-L1 inhibiting therapy and other immunotherapy are eligible; patients taking hormonal anti-cancer therapies or steroids for central nervous system (CNS) edema management that, in the opinion of the investigator, are appropriate to continue are eligible. * Any prior PD-1/PD-L1 therapy-related AE that, in the opinion of the investigator, warrants exclusion from participation in this trial * Administration of any investigational agent within 4 weeks prior to initiating study treatment * Known active hepatitis B or C * Pregnancy or breastfeeding * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Improved Disease Control | Up to 24 weeks following SRT | 1. Number of patients with improved disease control at 24 weeks following RT \[Time Frame: up to 24 weeks following RT\] 1a. Number of participants with improved disease control (SD, PR or CR) at 24 weeks per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 1b. For participants enrolled with brain metastases: number of participants with improved disease (SD, PR or CR) control at 24 weeks per per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Response in Irradiated Tumor Sites | Up to 24 weeks following SRT | Number of participants with treatment response in irradiated tumor sites at 24 weeks post-RT. |
| Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Up to 24 weeks post-RT | Number of participants with treatment response in non-irradiated tumor sites at 24 weeks post-RT |
| Number of Patients Alive | 2 years following SRT | Number of patients who are alive at 2 years after completion of SRT |
| Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | Up to 24 weeks following SRT | Number of participants alive and without progression (irSD+irPR+irCR) at 24 weeks post-RT per unidimensional immune-related response criteria (irRC) 1b. For participants enrolled with brain metastases: number of participants alive and without progression (SD+PR+CR) at 24 weeks post-RT per immune Response Assessment in Neuro-Oncology (iRANO) |
| Number of Participants With Immune-related Toxicity From the Regimen | Up to 2 years following RT | Number participants with immune-related AEs (irAEs) that require both checkpoint-inhibitor discontinuation and initiation of steroids reported per CTCAE v5.0 |
| Radiobiological Signatures Associated With the Regimen | Up to 52 weeks post SRT | Number participants with samples collected and number of participants with samples analyzed for immunologic effects of the regimen |
| Number of Participants With Grade 3 or Greater Toxicity | Through 8 weeks following SRT | Number of participants with grade 3 or greater toxicity from the regimen through 8 weeks following RT |
Countries
United States
Participant flow
Recruitment details
No participants enrolled in Arm B.
Participants by arm
| Arm | Count |
|---|---|
| A: Patients Receiving SBRT (Body) Irradiation Only Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations. | 4 |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations. | 0 |
| C: Patients Receiving SRS (Brain) Irradiation Only Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations. | 1 |
| Total | 5 |
Baseline characteristics
| Characteristic | B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Total | C: Patients Receiving SRS (Brain) Irradiation Only | A: Patients Receiving SBRT (Body) Irradiation Only |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Continuous | — | 67.8 years | 67 years | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | — | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | — | 5 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | — | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | — | 4 Participants | 0 Participants | 4 Participants |
| Region of Enrollment United States | — | 5 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | — | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | — | 3 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 3 / 4 | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 | 0 / 1 |
Outcome results
Primary
Number of Patients With Improved Disease Control
1. Number of patients with improved disease control at 24 weeks following RT \[Time Frame: up to 24 weeks following RT\] 1a. Number of participants with improved disease control (SD, PR or CR) at 24 weeks per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 1b. For participants enrolled with brain metastases: number of participants with improved disease (SD, PR or CR) control at 24 weeks per per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM)
Time frame: Up to 24 weeks following SRT
Population: No participants enrolled in Arm B
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Not Evaluable | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Partial Response | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Complete Response | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Not Evaluable | 2 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Complete Response | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Partial Response | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Stable Disease | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Progression at or before 24 Weeks | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Stable Disease | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Progression at or before 24 Weeks | 2 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Partial Response | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Complete Response | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Partial Response | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Progression at or before 24 Weeks | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Stable Disease | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Progression at or before 24 Weeks | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Complete Response | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Not Evaluable | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Not Evaluable | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Stable Disease | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Not Evaluable | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Complete Response | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Partial Response | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Partial Response | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Stable Disease | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Stable Disease | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Complete Response | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Progression at or before 24 Weeks | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1a: Number of participants with improved disease control | Progression at or before 24 Weeks | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients With Improved Disease Control | 1b: Participants enrolled with brain metastases number of participants with improved disease control | Not Evaluable | 0 Participants |
Secondary
Number of Participants With Grade 3 or Greater Toxicity
Number of participants with grade 3 or greater toxicity from the regimen through 8 weeks following RT
Time frame: Through 8 weeks following SRT
Population: No participants enrolled in Arm B
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A: SBRT (Body) Irradiation Only | Number of Participants With Grade 3 or Greater Toxicity | 1 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Participants With Grade 3 or Greater Toxicity | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Grade 3 or Greater Toxicity | 0 Participants |
Secondary
Number of Participants With Immune-related Toxicity From the Regimen
Number participants with immune-related AEs (irAEs) that require both checkpoint-inhibitor discontinuation and initiation of steroids reported per CTCAE v5.0
Time frame: Up to 2 years following RT
Population: No participants enrolled on Arm B
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: SBRT (Body) Irradiation Only | Number of Participants With Immune-related Toxicity From the Regimen | Participants with no immune related AE's (irAEs) | 2 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Immune-related Toxicity From the Regimen | Not Evaluable | 1 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Immune-related Toxicity From the Regimen | Participants with immune-related AEs (irAEs) | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Immune-related Toxicity From the Regimen | Participants with no immune related AE's (irAEs) | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Immune-related Toxicity From the Regimen | Not Evaluable | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Immune-related Toxicity From the Regimen | Participants with immune-related AEs (irAEs) | 0 Participants |
Secondary
Number of Participants With Treatment Response in Irradiated Tumor Sites
Number of participants with treatment response in irradiated tumor sites at 24 weeks post-RT.
Time frame: Up to 24 weeks following SRT
Population: No participants enrolled on Arm B.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Partial Response at Irradiated Sites | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Not assessed at week 24 due to overall progression | 2 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Stable Disease at Irradiated Sites | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Not Evaluable | 2 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Complete Response at Irradiated Sites | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Not Evaluable | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Complete Response at Irradiated Sites | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Partial Response at Irradiated Sites | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Stable Disease at Irradiated Sites | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Irradiated Tumor Sites | Not assessed at week 24 due to overall progression | 0 Participants |
Secondary
Number of Participants With Treatment Response in Non-irradiated Tumor Sites
Number of participants with treatment response in non-irradiated tumor sites at 24 weeks post-RT
Time frame: Up to 24 weeks post-RT
Population: No participants enrolled on Arm B
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Partial Response at non-irradiated sites | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Progression at non-irradiated sites at or before 24 weeks | 2 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Stable Disease at non-irradiated sites | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Not Evaluable | 2 Participants |
| A: SBRT (Body) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Complete Response at non-irradiated sites | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Not Evaluable | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Complete Response at non-irradiated sites | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Partial Response at non-irradiated sites | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Stable Disease at non-irradiated sites | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Participants With Treatment Response in Non-irradiated Tumor Sites | Progression at non-irradiated sites at or before 24 weeks | 1 Participants |
Secondary
Number of Patients Alive
Number of patients who are alive at 2 years after completion of SRT
Time frame: 2 years following SRT
Population: No participants enrolled on Arm B
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: SBRT (Body) Irradiation Only | Number of Patients Alive | Not evaluable | 1 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients Alive | Number of participants not meeting 2 year survival threshold | 1 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients Alive | Number of participants meeting 2 year survival threshold | 2 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive | Not evaluable | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive | Number of participants meeting 2 year survival threshold | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive | Number of participants not meeting 2 year survival threshold | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive | Number of participants not meeting 2 year survival threshold | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive | Number of participants meeting 2 year survival threshold | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive | Not evaluable | 0 Participants |
Secondary
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
Number of participants alive and without progression (irSD+irPR+irCR) at 24 weeks post-RT per unidimensional immune-related response criteria (irRC) 1b. For participants enrolled with brain metastases: number of participants alive and without progression (SD+PR+CR) at 24 weeks post-RT per immune Response Assessment in Neuro-Oncology (iRANO)
Time frame: Up to 24 weeks following SRT
Population: No participants were enrolled in Arm B
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| A: SBRT (Body) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Progression per irRC at or before 24 Weeks | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Not Evaluable | 3 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Not Evaluable | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Progression Free Survival per irRC at 24 wks | 0 Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Progression Free Survival per irRC at 24 wks | NA Participants |
| A: SBRT (Body) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Progression per irRC at or before 24 Weeks | 1 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Progression Free Survival per irRC at 24 wks | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Progression per irRC at or before 24 Weeks | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Not Evaluable | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Progression per irRC at or before 24 Weeks | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Progression Free Survival per irRC at 24 wks | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Not Evaluable | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Not Evaluable | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Progression Free Survival per irRC at 24 wks | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Progression per irRC at or before 24 Weeks | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1a. Number of participants alive and without progression | Not Evaluable | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Progression Free Survival per irRC at 24 wks | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC) | 1b.For participants enrolled with brain metastases | Progression per irRC at or before 24 Weeks | 0 Participants |
Secondary
Radiobiological Signatures Associated With the Regimen
Number participants with samples collected and number of participants with samples analyzed for immunologic effects of the regimen
Time frame: Up to 52 weeks post SRT
Population: No participants enrolled on Arm B
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: SBRT (Body) Irradiation Only | Radiobiological Signatures Associated With the Regimen | Number of participants with samples collected | 3 Participants |
| A: SBRT (Body) Irradiation Only | Radiobiological Signatures Associated With the Regimen | Number of participants with no samples collected | 1 Participants |
| A: SBRT (Body) Irradiation Only | Radiobiological Signatures Associated With the Regimen | Number of participants with samples analyzed for immunologic effects of the regimen | 0 Participants |
| B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation | Radiobiological Signatures Associated With the Regimen | Number of participants with samples analyzed for immunologic effects of the regimen | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Radiobiological Signatures Associated With the Regimen | Number of participants with samples analyzed for immunologic effects of the regimen | 0 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Radiobiological Signatures Associated With the Regimen | Number of participants with samples collected | 1 Participants |
| C: Patients Receiving SRS (Brain) Irradiation Only | Radiobiological Signatures Associated With the Regimen | Number of participants with no samples collected | 0 Participants |