- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03220854
SBRT + PD-1/PDL-1 Inhibiting Therapy for Advanced Solid Tumors After Dz Control on PD-1/PDL-1 Tx
Phase 2 Clinical Trial of Stereotactic Radiotherapy (SRT) and PD-1 or PD-L1 Inhibiting Therapy for Treatment of Advanced Solid Tumors After Disease Control on PD-1 or PD-L1 Inhibiting Therapy
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A: 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
|
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.
Other Names:
Standard of Care - patient will continue to be given the same PD-1 inhibitor they were receiving prior to study registration
Other Names:
Standard of Care - patient will continue to be given the same PD-L1 inhibitor they were receiving prior to study registration
Other Names:
|
Experimental: 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
|
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.
Other Names:
Standard of Care - patient will continue to be given the same PD-1 inhibitor they were receiving prior to study registration
Other Names:
Standard of Care - patient will continue to be given the same PD-L1 inhibitor they were receiving prior to study registration
Other Names:
|
Experimental: 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
|
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.
Other Names:
Standard of Care - patient will continue to be given the same PD-1 inhibitor they were receiving prior to study registration
Other Names:
Standard of Care - patient will continue to be given the same PD-L1 inhibitor they were receiving prior to study registration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Improved Disease Control
Time Frame: Up to 24 weeks following SRT
|
|
Up to 24 weeks following SRT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
Time Frame: 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) |
Up to 24 weeks following SRT
|
Number of Participants With Treatment Response in Irradiated Tumor Sites
Time Frame: Up to 24 weeks following SRT
|
Number of participants with treatment response in irradiated tumor sites at 24 weeks post-RT.
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Up to 24 weeks following SRT
|
Number of Participants With Treatment Response in Non-irradiated Tumor Sites
Time Frame: Up to 24 weeks post-RT
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Number of participants with treatment response in non-irradiated tumor sites at 24 weeks post-RT
|
Up to 24 weeks post-RT
|
Number of Patients Alive
Time Frame: 2 years following SRT
|
Number of patients who are alive at 2 years after completion of SRT
|
2 years following SRT
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Number of Participants With Grade 3 or Greater Toxicity
Time Frame: Through 8 weeks following SRT
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Number of participants with grade 3 or greater toxicity from the regimen through 8 weeks following RT
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Through 8 weeks following SRT
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Number of Participants With Immune-related Toxicity From the Regimen
Time Frame: Up to 2 years following RT
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Number participants with immune-related AEs (irAEs) that require both checkpoint-inhibitor discontinuation and initiation of steroids reported per CTCAE v5.0
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Up to 2 years following RT
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Radiobiological Signatures Associated With the Regimen
Time Frame: Up to 52 weeks post SRT
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Number participants with samples collected and number of participants with samples analyzed for immunologic effects of the regimen
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Up to 52 weeks post SRT
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alfredo Urdaneta, M.D., Massey Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-16-12436
- P30CA016059 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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